robert m. isackson
Did you know that we have a voice and people who matter listen? Indeed, since 1922, the NYIPLA has been your voice on all matters of intellectual property law. For example, since June 2021, we’ve seen:
The U.S. Supreme Court’s recent decision in Minerva Surgical, Inc. v. Hologic, Inc. et al. No. 20-440, June 29, 2021, come down on all fours with the position advanced in NYIPLA’s amicus brief, prepared by Amicus Brief Committee volunteers, and filed in February 2021;
U.S. Senators Tillis and Cotton hold Patent Eligibility Roundtable sessions to explore stakeholder views on potential patent eligibility reform, and NYIPLA’s Legislative Action Committee sent several representatives to participate;
The U.S. House Judiciary Committee staff hold roundtable discussions concerning the introduction of the SHOP Safe Act, to address liability for online counterfeiting, and again NYIPLA’s Legislative Action Committee sent a representative to participate;
Our PTAB committee has had senior PTAB judges attend its monthly meetings, to exchange information with our members regarding PTAB operations and procedures; and
Our Trademark Law Committee is having a Deputy Chief Judge at the TTAB present an update at the upcoming Hot Topics CLE series.
My point here is that that the NYIPLA does some pretty cool stuff involving the hottest issues in IP. We are known and we get around.
As a member driven organization based in NY/CT/VT/NJ, NYIPLA members have the opportunity to tell us what they really think is important and why, so that our voice fairly reflects our constituency. If you’re already involved, you know what I mean, thank you, and consider bringing a colleague along to a next event If you’re a member but not yet involved, or not yet a member, consider this an open invitation to join one or more of our twenty-six standing committees (one of them will interest you). And participate, tell us what you’re really thinking, help set policy and drive consensus, and make a difference. Our regional IP association sits in the most exciting, diverse and challenging IP ecosphere, and with your talented help we will reflect the personal and professional diversity of our region. As applied to NYIPLA, Groucho Marx had it backwards – we embrace those who want to have us as their IP association.
As the incoming President, I learned that it’s now my responsibility to actually write this column in The Report. Nothing like a deadline to motivate a lawyer into action. Rather than recap matters The Report already covers, I figured that I’d open with a soft membership sell. This will be a focus of my efforts for this year, to expand our active membership base and strengthen our voice. Check. Now, on to the this is my first column issues before addressing that little elephant of a pandemic that we’ve all been dealing with.
No, when I joined the NYIPLA in 1982, I never dreamed that I would be President of NYIPLA. Truth be told, I only planned to stay in New York “for a couple of years.” I was going to get some experience working at a then prestigious IP boutique (of blessed memory), before returning “home” to Michigan with some serious New York IP law firm credentials on my resume. But I caught the NY IP bug and the vitality of practicing IP law here, and stayed. Sort of. Meaning I moved out to New Jersey. And after decades of crossing the George Washington Bridge to work, shifted to the Tappan Zee/Mario Cuomo Bridge when I joined my current firm in White Plains in 2018.
NYIPLA can certainly claim some of the stickiness that kept me here. My first experience was attending periodic luncheons held at some club in Manhattan (can’t remember which one). There, we’d socialize, chat about work or with opposing counsel and hear from senior lawyers on various IP issues or cases then of interest. Always some educational component. My second exposure was the annual dinner in honor of the Federal Judiciary (fka the Patent Prom), where the bets were on who would bring in a portable TV to watch the NCAA basketball playoffs, whether someone would try to buy a bottle of vodka or scotch for the table, and whether we would be able to hear the speeches. Truly a special experience, then and now. My third exposure was joining a committee focused on unfair competition and patent misuse, because I wanted to learn more about the topic. It worked, well. The lesson I took away early was how NYIPLA was the place where lawyers, who in other circumstances won’t hesitate to shred opposing counsel to advance their clients’ interests, could come together as friends (okay, at least as cordial and respectful colleagues), debate and learn from one another, and have some fun. These NYIPLA traditions, except the luncheons, are worthy of continuing.
As for the dark cloud of the pandemic, it’s been hugely disruptive, demanded flexibility and required a pivot to virtual operations. Not only for our day jobs, but also for the NYIPLA. Tragically, we had to cancel the 2020 Judges’ Dinner, with insufficient time to make it virtual on the scheduled day of, and with a false hope that maybe we could just reschedule it for October 2020. Plainly that didn’t work out. With all in-person events cancelled, by May 2020 we were rolling out virtual platforms for our various CLE events and held our first virtual Annual Meeting. Life at NYIPLA thus continued on the internet and telephone; we just hummed along (I’d say “zoomed” but I don’t want to confuse the great work of our committees with the now eponymous brand).
With high vaccination rates and declining incidents of COVID-19 infections in our region, our local governments are easing many of the social restrictions previously in place. Many of us have workplaces that are considering, if not already implementing, a phased (or total) reopening process. Folks once again are going into an office with other co-workers and co-working there, in contrast to my five transient visits to my office since March 2020 just to pick up a file. Anecdotally, most workplaces seem to be targeting after summer for their rolling reopening process. Yet all are keeping an eye on COVID-19 variants, like the Delta variant, to see whether that will stimulate a wave and reinstate any restrictions.
NYIPLA’s concerne about the safety and welfare of our members extends as well as the greater community with whom our members interact. We are conscious that while we enhance our members’ professional experience, we don’t cut any paychecks and should not unfairly increase anyone’s risk of exposure or transmission until we have reasonable assurances we can resume in person activities safely, consistent with government guidelines. So we will watch how the reopening process unfolds, and take a cautious wait and see approach.
In the short term, we will continue with our committees meeting and our CLE and other events happening virtually, and least through the summer. If the lights stay green, we will figure out a path to resume in person activities. So, yes, we have begun to cautiously plan for an in person Judges’ Dinner on March 25, 2022, and please save that date. And no, I don’t plan to be cooking at the dais or anywhere – no way I’m going to try and top immediate past president Colman Ragan’s masterful exposition this past April. Until the next Report.
NYIPLA President's Corner
In This Issue:
Q&A with Laura Chubb and Mark Schildkraut Co-Chairs of NYIPLA’s Trade Secrets Committee
A Look at the Data: PTAB Successes, Outcomes and Results
By: Charles R. Macedo, Ken Adamo, Chris Lisiewski, Thomas Hart, and Amy Towell
Beyond Copyright: Protecting Software APIs in the Wake of Google v. Oracle
By: Eugene Chang, Devon Edwards, and Mary Stottele
Notable Trademark Decisions, June 2021
By: Scott Greenberg and Anna Antonova
"As Time Goes By - It Took a Village"
By Dale Carlson
Global Diagnosis: The Future of Diagnostic Method Patents in Precision Medicine
By: Charlotte Geaghan-Breiner
Moving Up and Moving On
Welcome New Members
What is one issue that the Trade Secrets Committee is focusing on this year?
This year the trade secrets committee focused on providing a CLE program to discuss the intersection of trade secret protection with patent protection. This intersection is important for companies across a broad spectrum of industries to consider when seeking to create strong and broad protection for their know-how and inventions. To tackle this issue, our committee put together a great CLE program as well as drafted a white paper focusing on artificial intelligence-related technologies.
Why did you pursue a career in intellectual property law?
Laura: I pursued a career in intellectual property law because I truly enjoyed my science studies in undergrad (molecular biology), however, I did not envision myself working in a traditional research setting. I enjoy the advocacy of law and the teamwork environment of litigation. So marrying the challenge of a scientific problem with the law gave me the best of both worlds.
Mark: I’ve always enjoyed learning about cutting edge technology and I therefore pursued an electrical engineering undergraduate degree. Similar to Laura, at some point (my junior year in college to be precise), I recognized that did not want to seek a conventional R&D career path, and therefore looked into going to law school or pursuing an MBA. When I learned about IP law, which allowed me to work with a host of technologies, advance the innovation process and impact business strategy, I had felt I found my professional calling. I have been practicing IP law for 25 years and I am so happy with the my career choice and the experiences it has afforded me.
Do you work with a particular type of intellectual property in your practice?
Laura: Throughout my career I have worked in all areas of intellectual property – patents, trademarks, copyrights, and trade secrets – in both procurement and litigation. Most of my time is spent in patent litigation although I also regularly help clients with trademark procurement and enforcement matters. A lot of my patent litigation work has been focused in the life sciences, but I have also handled matters related to a wide spectrum of other technologies like software and building materials. For brand protection matters, my clients have offered a broad range of products like jewelry, mattresses, specialty food, and clothing.
Mark: After graduating law school, I worked in private practice (IP law firm then multinational general practice law firm) focusing primarily on patent litigation and some patent prosecution. At the risk of sounding a bit cliché, I truly believe my prosecution background made me a better litigator and my litigation experience made me a better prosecutor. Several years later, in 2005, I moved in-house and joined the Law Group of med-tech leader Becton, Dickinson and Company (BD) – a global, 70,000 employee company that develops lifesaving medical devices and diagnostic instruments (including syringes and diagnostic equipment widely used for combatting the COVID-19 pandemic). And, from that point, my practice immediately expanded and has continually evolved through today. For example, given that BD is a multinational company, my practice moved from being US-focused to one that is worldwide. (In my first month at BD, I flew to Dusseldorf for a Germany patent litigation.) In addition, my thinking and strategy shifted from protecting a given technology or innovation to advancing critical business strategies– whether it’s ensuring business continuity through freedom to operate, protecting sensitive information by perfecting and enforcing critical trade secrets, seeking relief from parties practicing our proprietary technology, or the like.
What do you see as a current challenge facing intellectual property attorneys?
Laura: Intellectual property attorneys have to navigate hot to protect clients’ inventions at the forefront of any industry. Although it is not a new challenge, we constantly have to address the questions of how to best protect new technologies and whether that protection fits within the construct of the current intellectual property laws. For example, what intellectual property should be used to protect artificial intelligence-related inventions.
Mark: In addition, as the marketplace is essentially global, IP attorneys need to think broadly when devising strategies for protecting a client’s technology and commercial offerings. For example, when advising a US client on trade secret misappropriation occurring overseas, should the approach involve the extra-territorial nature of the relatively new Defend Trade Secrets Act (DTSA), the laws of the foreign country, or both? When a client’s patents are infringed, should the litigation strategy be on a single front (one country) or multi-jurisdictional? Although the US is often an important market and has an established legal system, an ex-US or global strategy may afford your client with best opportunity to achieve the desired business outcomes.
Are there any recent or foreseen changes (in the law or market) that will have an impact on your practice?
Laura: Although not a recent case, the TC Heartland case and its many follow-on cases changed the patent litigation venue landscape. Because of that decision and in order to avoid disputes about venue, the most popular venues for patent litigation have changed and narrowed in recent years. If you are representing the plaintiff, the result of TC Heartland is less choice for where to file your lawsuit without a potential dispute. This is important since venue can affect things like the timeline to trial, amount of damages likely to be awarded, and whether there are specific local rules related to patent litigation to control the schedule.
Mark: And, turning to trade secrets, we have recently passed the five year anniversary of the implementation of DTSA. This has afforded trade secret litigants access to federal court, advanced more consistency and certainty in trade secret cases, and as mentioned above established global reach in some cases. While the full impact arising from DTSA is yet to be seen, with the steep rise in trade secret cases over the past five years, it is quite apparent that DTSA has been well received and I expect this will continue.
What do you love to do other than work?
Laura: Outside of work my favorite thing to do is spend time with my husband and two little girls. We love to explore the city, travel to see family, play games together and read good books.
Mark: My children (one in college and another heading to law school) are a bit older than Laura’s, so they are out of the house. With some more free time, my wife and I have been enjoying the outdoors – going on hikes – and I have taken up running; in fact, I ran my first (and perhaps last?) marathon. Recently, I decided to pursue additional education, and this September I am embarking on a two-year online LL.M. program in Information Technology Law at the University of Edinburgh School of Law (Scotland, UK).
What advice would you give to someone considering a career in intellectual property law?
Laura: My advice to someone considering a career in intellectual property law would be to explore all areas of intellectual property at the beginning of their career because even if they feel certain that they want to focus on patent prosecution, for example, they may end up loving trademark litigation. No matter what area an attorney later focuses their practice, having a breadth of experience in intellectual property will prove useful as most of a company’s technology and know-how is not necessarily protected by one type of intellectual property in isolation. Also, picking a career in intellectual property law can almost guarantee that you will be working with a company’s assets that are driving real value, and that is exciting!
Mark: Oftentimes, young attorneys are strictly thinking about litigation vs. prosecution or considering whether they should be a “patent lawyer” or a “trademark lawyer”. Yet, there is so much more. IP law has evolved and we are seeing civil trade secret misappropriation actions brought in state and federal court, as well as in criminal proceedings through referrals made to law enforcement. In addition, cybersecurity, big data and privacy law considerations often require consideration when sensitive and often critical information has been misappropriated. Further, technology is changing – such as AI – and may require new protection and enforcement strategies. Also, as I previously mentioned, think globally. And, finally, while this does not apply to IP law only . . . make sure you are providing best in class legal service and value. As in-house counsel, I look for three things from my outside counsel: (i) strong legal and business advice (don’t stop short at the legal advice and say “well, that’s a business decision”); (ii) value (need to find a fee arrangement that’s win/win); and (iii) easy to work with (for example, make sure your phone number is at the bottom of your email). If you perfect this criteria, your colleagues and clients will seek you out.
Q&A with Laura Chubb and Mark Schildkraut Co-Chairs of NYIPLA’s Trade Secrets Committee
On June 1, the PTAB Committee presented a webinar entitled “PTAB Success, Outcomes and Results” analyzing key trends of petitions for IPR, PGR, and CBMs at the PTAB. The USPTO provided its latest statistics as reported in their quarterly roundup, found on their website, and Docket Navigator prepared a special report for this presentation reporting on comparable statistics over the life the PTAB since 2012, when IPR, PGR and CBM proceedings first commenced. To view the full presentation please go to https://www.nyipla.org/assnfe/ev.asp?ID=1397. In this article, we report on some of the highlights of what the statistics show.
Petitions by Trial Type
Over the course of the life of the Patent, IPRs have been the dominant form of petitions filed with the PTAB for institution of a trial. According to the USPTO’s most recent statistics, in the first six months of the USPTO’s Fiscal 2021 (October 1, 2020 – March 31, 2021), roughly 91% of the petitions filed with the PTAB for trial were IPRs, and 9% of the petitions filed were PGRS. Since the sunset period for filing CBMs expired in September 2020, no CBMs were filed.
The USPTO’s current data is consistent with historical filing rates as reported by Docket Navigator. Docket Navigator’s figures show that the ratio of IPRs to PGRs (including CBMs when they were available) is fairly consistent. Generally, IPRs represent roughly 90% of the petitions filed, with IPRs and CBMs (combined), reflecting roughly 10%.
While there has been a slight uptick in petitions filed for PGRs since CBMs have been discontinued, as both the USPTO statistics and Docket Navigator statistics demonstrate, PGRs, despite providing an option for post-Alice § 101 precedent, continue to be relatively unused.
Petitions Filed by Technology Type
According to the USPTO, petitions in the first six months of FY2021 are overwhelmingly in the field of electrical/computer technology, with mechanical and business methods constituting a significant portion of petitions filed as well:
Docket Navigator’s analysis confirms that this is an ongoing trend – Computers, Semiconductors, and Networking constitute a large portion of the challenges raised by Petitioners:
One interesting trend in particular is the increase in Networking, Multiplexing, and Cable category in the past few years. It’s possible that this is a result of the number of patents which have been issued that relate to 5G and a concomitant rise in post-grant challenges.
Outcomes by Petition, Patents, and Challenged Claim
According to the USPTO, for the first half of 2021, roughly a third of petitions were denied institution and roughly a third were settled. Of the remainder, 19% of petitions resulted in all claims being held as unpatentable, with only 5% resulting in all claims being held patentable and 4% resulting in some claims being patentable. A handful were dismissed or had adverse judgements. When looking at the same numbers, but by patent instead of by petition, the institutions denial rate goes down slightly; this helps to show the impact of multiple petitions (i.e. normally only one of them will be instituted).
As the outcomes by claim challenged graph shows, for those petitions which received a final written decision, roughly twice as many claims were held unpatentable as those that were held to be patentable.
Docket Navigator, meanwhile, shows that there is a disparity in the success rates between different types of trials, with challenges using PGR being less successful than IPRs (this may help to explain the relative lack of use of PGRs discussed earlier). It appears that only one-third of PGR petitions will result in at least one claim being held unpatentable, but this ratio is one-half for IPR petitions.
The overview of ‘PTAB Outcomes’ from Docket Navigator seems to paint a slightly rosier picture for patent owners than the USPTO’s data. However, this may be because Docket Navigator separately counts each failed petition, even if the same claims of the same patent is ultimately knocked out by a second successful petition.
Looking next to the data on final written decision, Docket Navigator shows that once a trial is instituted, and a final written decision issued patent owners are unlikely to succeed. Because Docket Navigator counts each final written decision issued on the same claim separately, the statistics may be even worse for Patent Owners to the extent that multiple petitions are granted on the same patent.
The data from the USPTO and Docket Navigator both show that PTAB trials, once instituted, are difficult for patent owners to win, especially if a final written decision is instituted.
Lifecycle of PTAB Cases
Docket Navigator offers a unique perspective on the life cycle of a PTAB proceeding, and when and how a petition is likely to be resolved.
The flow chart above aggregates the individual lifecycles of patent challenges at the PTAB since 2012, including petitions currently pending. Note that because of the Supreme Court’s decision in SAS, there have been no partial institutions since 2018.
Furthermore, as year-by year data shows, patent challengers win a fair amount of the time once a trial is instituted, but petitions are also frequently denied. Settlements, even prior to Institution, are also relatively frequent. This aggregated data provides an interesting complement to the data on outcomes discussed earlier.
One of the statistics that is often difficult to determine is how many PTAB APJs there are and how many decisions each one signs onto. Docket Navigator tracks the lead APJ for each decision or opinion issued in a PTAB proceeding.
In a special report for NYIPLA, Docket Navigator tabulated the number of PTAB APJs who signed an opinion for each year from 2012 through present. As can be seen, the number of active APJs has increased significantly since 2012, although it decreased marginally in 2020.
Another interesting analysis performed by Docket Navigator is in how many decisions each of the APJs were lead APJs. In this regard, Docket Navigator showed that approximately 24 APJs signed more than 80 decisions as Lead APJs during the life of the PTAB, while roughly 90 APJs signed less than 30 PTAB decisions during their tenure so far with the PTAB.
Settlements and Requests for Adverse Judgements
Settlements are one of the more common outcomes in PTAB proceedings, and the USPTO tracks the average settlement rate of petitions. As this table from USPTO shows, the raw number of settlements is similar both before and after institution. Given that many patents are knocked out prior to institution, however, the rate of settlement for petitions which never reach institution may be higher.
Another outcome includes requests for adverse judgements, and Docket Navigator provided us with the number of requests for adverse judgements – it’s fairly low, and has been decreasing almost annually. This is in contrast to the number of settlements, which has remained fairly consistent each year.
Decisions on Institution
Of course, one of the most important points of data is the number of institutions granted. These USPTO charts, depicting institution rates, help to show a point made earlier – that trials are instituted on patents more often than petitions.
The institution rate when measured on a per-patent basis, is still fairly high – somewhere near 60% – regardless of whether one looks at the USPTO or Docket Navigator data.
Whether or not this marginally downward trend continues remains to be seen. Docket Navigator’s early data from 2021 suggests that it will not. Curiously, the PTAB’s decision in Fintiv, which was made precedential in 2020, has not seemed to have made an impact on the institution rate of patents, although it likely has reduced the institution rate of petitions.
Impact of Fintiv
Docket Navigator is capable of text-specific filtering of data, and this can help to show the impact that certain cases, like Fintiv, have on PTAB trials. The below graph depicts the level of success in all PTAB cases which mention Fintiv in the text.
As the chart from Docket Navigator shows, roughly 64% of cases mentioning Fintiv were instituted (“granted”). This is remarkably similar to overall rate of institution (potentially even higher) and is inconsistent with the general sentiment that Fintiv was a sea change.
Request for Rehearingat the PTAB
Data on the number of rehearings that the PTAB grants related to the decision to institute shows a low chance of success.
This bar graph and corresponding data table confirm that the overwhelming number of the requests for rehearing are denied. 2019 and 2020 may be as high as it is because of requests related to rehearing on partial institutions after SAS was decided in 2018.
Motions to Amend
Another route that patent owners can take is pursuing motions to amend. As with requests for rehearing, success is infrequent, although the Federal Circuit’s decision in Aqua Products seems to have increased the rate of success.
Despite Aqua Products, which shifted the burden of proof in motions to amend to the petitioner, the number of grants on these motions continues to be relatively low (10 in 2019 and 9 in 2020). The PTAB’s pilot program, where the PTAB gives preliminary guidance on the motion to amend, may also be having some level of impact here.
PTAB Appeals in the Federal Circuit
As Docket Navigator shows, patent owners, are more likely, by a significant margin, than petitioners to seek review at the Federal Circuit. This may be because patent owners are more likely to be facing an adverse, appealable, decision – as discussed earlier, claims are more likely than not to be cancelled once a final written decision is issued, and appeal is not available for the PTAB’s decision to institute.
That said, success rates remain low. As Docket Navigator shows, in the typical case, the Federal Circuit will affirm the PTAB’s decision (note that the ‘vacated’ categories are likely due to Arthrex).
The number of reversals (even in part) are less than 5% of the total for IPRs, for example. The odds for PGRs are better, but the sample size is too small to draw any conclusions.
Review of Supreme Court Cases
Finally,the number of petitions for certiorari granted by the Supreme Courtis surprisingly high. In most areas of law,the Supreme Court receives roughly 7,000 to 8,000 certiorari petitions each term, with a grant rate of roughly 1%. Data from Docket Navigator tells a different story with respect to PTAB petitions. While the number of cert. petitions granted is only about 10%, this is surprisingly high given the average rate in other areas of law.
Some of the cases which the Court granted cert. on include: Cuozzo Speed Techns. LLC v. Lee, 136S.Ct. 2131 (2016), SAS Inst. Inc. v. Iancu, 138S.Ct. 1348 (2018), Oil States Energy v. Greene’s Energy Group, 138S.Ct. 1365 (2018), Return Mail v. U.S. Postal Services, 139S.Ct. 1853 (2019), Thryv, Inc. v. Click-to-Call Techn., LP, 140S.Ct. 1367 (2020), and United States v. Arthrex, No. 19-1434 (US 2020). Additionally, SAS ad one follow one case and Thryv had three.
The data from the USPTO and Docket Navigator both help to show important trends at the PTAB, from general outcomes to the impact of cases and decisions being designated precedential.
Sincere thanks to Janet Gongola, the Vice Chief Judge for Engagement at the USPTO, for providing as with the most recent USPTO data.
About the Authors
Charles R. Macedo is a partner, Chris Lisiewski is an associate, and Thomas Hart is a law clerk at Amster, Rothstein & Ebenstein LLP. Their practices specialize in intellectual property issues, including litigating copyright, trademark, patentand other intellectual property disputes.
Ken Adamo is the owner of the Law Offices of Kenneth R. Adamo and provides counselling regarding trial and appellate strategy and tactics in litigation and trials before US courts, the Federal Circuit, USITC and the PTAB, with particular attention to IP trials, post grant proceedings and ADR law.
Mr. Macedo and Mr. Adamo are the Co-Chairs of the PTAB Committee. Mr. Lisiewski is the Co-Chair of the Inventor of the Year Committee and Coordinator of the PTAB committee. Mr. Robert Rando is the First Vice President of the NYIPLA and Board Liaison for the PTAB committee.
Amy Towell is Chief Operations Office and co-founder of Docket Navigator, and manages information procurement and workflow, assists customers with training and research questions, and helps direct the development of new products and features.
For more information, see PTAB Trial Statistics: FY21 Q2 Outcome Roundup, USPTO, https://www.uspto.gov/sites/default/files/documents/ptab_aia_fy2021_q2_roundup_.pdf
To see the full binder on Docket Navigator, visit https://search.docketnavigator.com/patent/binder/427447. A Docket Navigator account is required to access the data.
Supreme Court Procedure, SCOTUSBlog, https://www.scotusblog.com/supreme-court-procedure/.
A Look at the Data: PTAB Successes, Outcomes and Results
By: Charles R. Macedo, Ken Adamo, Chris Lisiewski, Thomas Hart, and Amy Towell
Disclaimer: The Docket Navigator graphics are being replicated and used with Docket Navigator's permission for NYIPLA publication in The Report Summer 2021.
Source: Docket Navigator
Source: Docket Navigator (Bottom)
Beyond Copyright: Protecting Software APIs in the Wake of Google v. Oracle
By: EUGENE CHANG , Devon Edwards, and Mary Stottele
In today’s connected world, in which more and more businesses are moving their operations and services to the “cloud,” APIs (application programming interfaces) are becoming increasingly important. APIs are the tools used to create connections between online platforms, gain access to data, and deliver functionality to a broad range of users. In a recent decision, the Supreme Court has clarified the limits of copyright protection afforded to certain types of API.
Wrapping up a decade of litigation, on April 5, 2021 the Supreme Court of the United States settled a long-running copyright dispute between Google and Oracle, with Justice Breyer writing for the majority in a 6-2 decision for Google. The case centered around the “declaring code” in 37 packages of Java Application Programming Interface (API) packages, which Google had used to build its Android platform for mobile devices. As described in the Court’s decision, declaring code allows programmers to call up prewritten computing tasks for use in their own programs, which then execute “implementing code.” The Court held that Google’s use was protected by fair use, relying heavily on the fast-changing realities of how software is developed and distributed in reaching its decision, and failing to reach the question of whether the “implementing code” was protected by copyright at all.
Although fair use is a fact specific inquiry—and although the Court’s decision addressed only API declaring code—Google v. Oracle may have broader implications for all software developers, especially as lower courts applying the decision may extend its holding to other forms of code and other unauthorized uses. Putting aside the question of whether certain businesses are better served by putting their APIs into the public domain in order to increase adoption, and potential network effects, with the scope of software copyright protection potentially in question, it is important for developers to consider alternative strategies to protect APIs. In this article, we discuss the scope of the Google v. Oracle decision, and potential avenues for pursuing alternative forms of protection.
The Court’s Decision
In its decision, the Court held that Google’s copying of 11,500 lines of declaring code, which are necessary to implement computer programs developed using the Java interface, was permissible fair use due to both the functional nature of the code being copied and the purpose of Google’s copying to create mobile applications for its Android platform. Notably, the Court declined to answer whether Oracle’s APIs were copyrightable. Dissenting, Justice Thomas, joined by Justice Alito, argued that the majority improperly lessened the scope of protection for computer software, a decision it could only reach by failing to address the question of copyrightability.
Background and History
Oracle filed suit against Google in the United States District Court for the Northern District of California in 2010, alleging both patent and copyright infringement. In a first trial, held in April 2012, the jury found that Google’s use of Oracle’s Java APIs infringed Oracle’s copyright in the software, but deadlocked on the issue of Google’s fair use defense. The district court set aside the jury finding, instead holding that the APIs were not copyrightable as a matter of law, reasoning that they represent a “precise command structure” that is utilitarian and functional in nature as a “system or method of operation.”
On appeal, the Federal Circuit reversed, holding that the Java APIs were entitled to copyright protection because Google “could have structured Android differently,” “could have chosen different ways to express and implement the functionality that it copied,” and could have offered the very same functionality without copying the declaring code from Oracle. The Supreme Court denied Google’s petition for writ of certiorari on the limited question of copyrightability of the APIs.
Following a second trial, the jury found that Google’s copying of the Java API was a fair use; Oracle again appealed, and the Federal Circuit again reversed, holding that “[a]lthough Google could have furthered copyright’s goals of promoting creative expression and innovation by developing its own APIs, or by licensing Oracle’s APIs for use in developing a new platform, it chose to copy Oracle’s creative efforts instead.” Following a second petition by Google, the Supreme Court granted certiorari on November 15, 2019, heard oral argument on October 7, 2020, and issued its decision on April 5, 2021, with Justice Breyer writing for a 6-2 majority, and Justice Thomas, joined by Justice Alito, in dissent.
Relying on the “Functional” Nature of Declaring Code, the Majority Opinion Found that Google’s Copying Was Fair Use
The majority, led by Justice Breyer, identified the two questions before the Court: whether the APIs at issue qualified for copyright protection, and whether Google’s copying was a fair use. Recognizing that Google needed only to prevail on one of the two issues, the court decided to answer only the latter, assuming arguendo that the APIs were copyrightable.
Applying the four fair use factors set forth in 17 U.S.C. § 107—“the purpose and character of the use,” “the nature of the copyrighted work,” “the amount and substantiality of the portion used,” and “the effect of the use upon the potential market for or value of the copyrighted work”—the Court noted that a “one-size-fits-all” approach was inappropriate, and that the factors must be balanced to reflect the relevant circumstances, including the realities of developing technology. “[J]ust as fair use takes account of the market in which scripts and paintings are bought and sold, so too must it consider the realities of how technological works are created and disseminated.”
The Court began its analysis with the second fair use factor, the nature of the copyrighted work, and held that the declaring code at issue was different from many other kinds of copyrightable code because it is inherently bound with uncopyrightable ideas. The Court pointed to trial testimony, which was “replete with examples of witnesses drawing this critical line between the user-centered declaratory code and the innovative implementing code,” the latter of which Google did not copy. Thus, even as the Court expressly declined to reach the question of copyrightability, the majority nonetheless deemed that declaring code is “further than are most computer programs … from the core of copyright,” weighing in favor of fair use.
The Court also held that Google’s use was transformative in character, supporting a finding of fair use. Considering the policy objectives of the Copyright Act, the Court noted that Google’s use was aimed at developing new products and platforms—namely, Android—a use consistent with the goal of copyright law to further creativity and innovation.
In considering the amount and substantiality of the portion of the Java APIs used by Google, the Court contrasted the 11,500 lines of code incorporated into Android with the several million lines of code that Google did not copy. The Court held that Google used only enough of the declaring code to ensure that programmers could “make use of their knowledge and experience using the Sun Java API when they wrote new programs for smartphones with the Android platform,” which further weighed in favor of fair use.
Finally, the Court determined that the impact on the market for the copyrighted work also supported a fair use finding. The Court held that this factor requires consideration of the public benefits produced by copying, and whether the benefits are related to copyright law’s concern for creative production and expression; because Google’s uses were beyond the developments and benefits Oracle had seen in its use of the code, to decline to find fair use would limit future creation of new programs.
In Dissent, Justices Thomas and Alito Reject the Majority’s “Categorical Distinction” Between Declaring and Implementing Code
Dissenting from the majority’s opinion, Justice Thomas and Justice Alito seized on what they perceived to be two fundamental errors in the Court’s opinion. Most notably, the dissent criticized the majority for failing to reach the question of copyrightability of the Java APIs, writing that doing so “gets the methodology backward” and provides unduly little copyright protection to the declaring code at issue. In particular, Justice Thomas argued that declaring code is closer to the core of copyright law than the majority contemplated, and is not inherently less worthy of copyright protection merely because it is bound with uncopyrightable ideas. Likewise, it was of no matter to the dissent that the value of the declaring code relied on the investment of third parties to learn it—the same is true, for instance, of Broadway musicals.
The Dissent also contended that the majority failed to appropriately consider the substantiality of Google’s use and the effect of Google’s copying on the market. Although Google only copied 4% of the Java API code, Justice Thomas contended that in this percentage was the “heart or focal points” of Oracle’s code, which draws programmers to the Java platform. Likewise, Google’s copying diminished licensing revenues for Oracle and limited Oracle’s opportunities to license Java APIs, despite Google’s “overwhemlimg[ly] commercial” use of the code. Nor was Google’s use of the Java APIs “transformative” merely because it used the code to develop new software programs and platforms—Justice Thomas argued that such an interpretation “eviscerates copyright”; just as a movie studio could not “convert[ ] a book into a film without permission, nor should software developers be able to avoid copyright infringement merely by creating new products from their use of a work.
Protecting Software Through Other Intellectual Property Regimes
Although the Supreme Court’s decision was facially narrow in scope—addressing only the copying of API declaring code—it may portend a weakening of software copyrights more generally, as Justice Thomas’s dissent cautioned. In particular, the majority’s recognition that fair use is a “flexible” doctrine, and that application of the copyright laws must “consider the realities of how technological works are created and disseminated,” may serve as a shot across the bow to many software developers who have relied primarily on copyright protection to secure rights in their works. In light of Google v. Oracle, we discuss alternative forms of protection across the different forms of intellectual property, including trade secret, patent, and trademark or trade dress law. To be clear—this is a high level overview meant to spark thought and discussion, not provide any all-encompassing solutions.
Software as a Trade Secret
By its very nature, the API code at issue in the Google v. Oracle decision was ill suited for trade secret protection. As the Supreme Court recognized, the value of that declaring code came from its widespread adoption; use of the Java APIs allowed—and allows—developers to write programs that are generally interoperable across several platforms. As the majority held, “its value in significant part derives from the value that those who do not hold copyrights, namely, computer programmers, invest of their own time and effort to learn the API’s system.” Nonetheless, trade secret protection may provide a valuable layer of protection for software developers, as it can protect not only specific code but also the code’s functionality, bridging elements of both copyright and patent law.
State and federal law provide trade secret protection to information that derives independent economic value from not being generally known or readily ascertainable, and is the subject of commercially reasonable efforts to maintain its secrecy. Given this broad definition, code that is not disclosed to the public may qualify for trade secret protection. Indeed, both internally-facing software and software licensed at a business-to-business level—with the inclusion of proper contractual language—can permit the requisite level of secrecy. Trade secret protection may also be available for features of commercially available software that are not easily ascertainable by users:for instance, the structure, methodologies, hierarchies, and functionalities of programs that are not described in detail. Thus, even where features of software are readily apparent to customers, a claim of trade secret misappropriation may be successful where one company hires a software engineer from a competitor and rapidly develops its own analogous suite, especially where evidence suggests that the engineer divulged the trade secret methods by which those features were developed. Moreover, the reach of federal trade secret law is extraterritorial, imposing liability either if the offender is a U.S. citizen or entity or if any use of the misappropriated trade secret—such as advertising, sales, or promotion—is committed in the country.
However, several recent cases illustrate the limitations of trade secret protection, including potentially unintentional disclosures to the public that may overcome trade secret status. For instance, in one case, a company gave each user of its programs “access to the software itself, as well as extensive training sessions, user manuals, explanatory videos, and feature update emails that explain how the software works and how to take advantage of each of its functionalities”—but none of them carried any “confidentiality” markings, the company never provided any representation that the software or its components were trade secrets, and it never required all users to maintain the information in secrecy, with only one individual required to agree to a click-wrap license for each corporate account. Another case suggests that in some circumstances, software developers may be forced to decide between seeking copyright and trade secret protection for their work; in order to sue for copyright infringement, the subject work must be registered with the Copyright Office, which, if made in unredacted form, can constitute a disclosure defeating trade secret protection. And in a third case, where a client received a full backup of a prior version of software, it could not be held liable for misappropriating the latest version, which was “cumulative” and included all the same features.
Patent Protection and Software
Where copyright law (at least theoretically) precludes the actual copying of code, and trade secret law may guard against unauthorized misappropriation of a developer’s proprietary code, tools, and development, patent law can provide an even broader scope of protection, preventing others from practicing the same technologies even if they are independently developed. However, while trade secret law broadly protects any valuable proprietary information, securing and maintaining patent protection on software is significantly more difficult, especially in light of the widespread ambiguity surrounding patent eligibility for computer-implemented inventions (among others) under 35 U.S.C. § 101. Companies should be aware of these risks when developing patent strategies, but should not hesitate to file patent applications where appropriate to protect novel and inventive features of their software.
Although there is no bar on patenting software per se, developers may face significant challenges in doing so, both in securing a patent from the Patent Office, and in maintaining it following an invalidity challenge from a potential infringer. For example, patentability could turn on whether the patent claims a “specific asserted improvement in computer capabilities… or, instead, on a process that qualifies as an ‘abstract idea’ for which computers are invoked merely as a tool.” In particular, merely “computerizing” a pre-existing task cannot confer patent protection, and courts often taken an expansive view in interpreting this requirement. Thus, for instance, a patent drawn to electronic file management may be analogized to a library “call system,” and methods of de-identifying client records could just as easily “be performed in the human mind or with pen and paper,” resulting in both instances in invalidation of the asserted claims.
Trade secret and patent law serve as polar opposites in more than just the scope of their protection. In particular, by seeking patent protection, applicants must spell out precisely how their invention works, and enable those reading the patent specification to practice the claimed technology. There is significant risk that putative inventors may disclose their proprietary innovation, only for the Patent Office to reject the application—or for the patent to be later invalidated in litigation or post-grant proceedings such as inter partes reviews—offering a teaching to the general public with no concomitant intellectual property protection. Thus, software developers should be careful to disclose no more than is absolutely necessary in patent applications, or, in some instances, to consider eschewing patent in favor of trade secret protection.
Software Trademark and Trade Dress Protection
Even where patent or trade secret law may not provide a recourse against competitors, software developers should also consider trademark and trade dress protection to preclude others from appropriating the look and feel of their programs. This protection may less applicable for the types of declaring code at issue in Google v. Oracle, but can be part of a valuable intellectual property strategy to protect the overall appearance of software.
Although trade dress protection primarily guards against confusion in the marketplace, a developer’s proprietary innovations may also contribute to the look and feel of software, providing a further level of protection. Of course, companies may already have registered trademarks for their trade names and product offerings, but in the wake of Google v. Oracle, they may also consider whether the code comprises a unique visual interface that is inherently distinctive, or that consumers have come to associate with the product or its developer. Trade dress can protect the image and overall appearance of a product, such as shapes, graphics, and color schemes, without being registered, but does not extend to functional features.
In the software context, trade dress claims have frequently arisen with respect to website design. For instance, where a competitor puts out a “clone” of one company’s website, a claim of trade dress may be appropriate—especially where the latter can point to “phone calls from customers who have confused the [allegedly] infringing software and websites for [its] rightfully-owned software and website.” Importantly, however, parties cannot protect their trade dress by merely pointing to a laundry list of features offered by the website; rather, they must describe precisely how those features create a protectable look and feel; for example, mere conclusory allegations could not establish “that the combination of blue headers, pause and forward buttons, and brightly colored boxes” are entitled to protection. In contrast, a claim for infringement could proceed where the alleged trade dress constituted an orange and light blue color scheme, where the trim of the website and the “buttons” were in orange and the website featured a light blue strip in the center of the website; the left-hand side of the strip announced “translate your website”; and the upper right hand of the website provided links labeled “HOW IT WORKS” and “PRICING.” In the same vein, specific hierarchies, methodologies, and functionalities provided by source code may also qualify for trade dress protection, provided that they likewise contribute to the overall look and feel of the software.
Contractual Provisions for Software Protection
In addition to intellectual property, companies should consider contractual language to protect their software from unauthorized use. In the past, companies may have been lax in this regard, distributing and licensing proprietary software code, including any APIs, without robust contractual safeguards, relying on their understanding that the code was protected by copyright and that any wholesale copying would not be a fair use. In the wake of Google v. Oracle, however, this may no longer be a viable approach. Indeed, given the Court’s distinction between implementing and declaring code, it will be particularly prudent for companies to identify and separately license these categories—
especially as lower courts will be increasingly forced to determine the scope of protection, and the strength of a fair use defense, for a particular set of code.
To best insulate themselves from legal uncertainty, licensors can identify and define code, in relevant contracts, as either implementing or declaring, ideally by adhering to the Court’s definitions as closely as possible. Simply labeling the entire API as implementing code in a contractual agreement might not prevent a court from finding that copying some portion constitutes a fair use, but clear delineation within a contract instrument may identify core, proprietary functionalities that cannot be copied. Where implementing code is identified, software developers can and should continue to license such code with strict provisions against copying, distributing, or making derivative works based thereon. Even if future decisions further erode copyright protections over software, language and provisions that can give rise to a breach of contract remedy can help safeguard a company’s code.
Where licensors identify any declaring code, they may have to make a decision: to either make the API available to the public or to attempt to protect it through confidentiality measures. If the developer seeks to encourage widespread interoperability with its implementing code products and does not have an already robust user base, it may consider releasing the API to the public.Giving away source code for free may come with risks, but—as with Java—it may spur widespread adoption, bolstering sales and use of proprietary software products that integrate via a public API.Again, contractual provisions may help mitigate against such downside risk; in particular, developers should consider instituting a public-facing end-user license agreement (“EULA”) that governs use of the API. In the EULA, the company can identify and distinguish between particular declaring and implementing code within the API, and dictate how it can be used—for instance, by prohibiting use of the API for commercial purposes. As a “click-through” agreement, the EULA might be afforded less protection by the courts than a negotiated contract, but can nonetheless offer more security and control over code than an unfettered release.
For companies that either already have a robust client base or that intend to maintain more control over their source code, protection can be achieved by licensing software under strict confidentiality requirements to preserve the ability to bring a breach of contract claim. Those standard API licenses should be reviewed in light of the Court’s decision in Google v. Oracle to ensure that code is best protected. In particular, licensees in certain jurisdictions may be able to argue that provisions purporting to restrict their right to assert a fair use defense are preempted by section 301(a) of the Copyright Act. Federal appellate courts have split on this question; some decisions have held that because a contract constitutes a promise between specific consenting parties, it is not preempted by the Copyright Act, while others have required a more fact-intensive inquiry to determine whether a particular contract provision regulates an activity that is an exclusive right under the Copyright Act and is therefore preempted.
Regardless, licensors can protect their API code without wading into federal copyright preemption doctrine by grounding provisions in confidentiality and anti-competition principles. The exact provisions will vary based on the type of software at issue and the goals of the company, but companies should consider adding three categories of provisions: confidentiality, use case limitations, and reverse engineering prohibitions. First, by requiring adherence to robust confidentiality provisions, licensees can be precluded from distributing company confidential information, which would include the API source code, and thereby limit their ability to distribute or share such code with others without breaching the contract. Second, although use cases will vary by licensor and product area, some exemplary conditions may permit use of the API code only if the licensee also has a services agreement in place with the licensor, or a valid subscription to a licensor proprietary software product. Such provisions may also limit use of the code to use with particular company services, limit the number of users that can access the code, or prohibit the code’s use by or with specific competitor products. These provisions are common within software licensing, can tie use of the API to a commercialized use of the product, and can limit how the code gets used. Third and lastly, companies should include provisions that prohibit reverse engineering of the API code. Although the Ninth Circuit has indicated that some limited instances of reverse engineering are a fair use of copyrightable source code, in general courts have been willing to uphold reverse engineering provisions when challenged on federal copyright preemption grounds.
Although the Supreme Court’s decision in Google v. Oracle arguably weakens copyright protection of APIs, software developers can still take action to protect their proprietary technologies. Companies should reexamine their intellectual property strategies, particularly those that extend beyond copyright. A robust intellectual property protection strategy can support a company’s business strategy, and ensure that the use of APIs by others is for the benefit of the company, not its detriment.
Google LLC v. Oracle Am., Inc., 141 S. Ct. 1183 (2021).
See Oracle America, Inc. v. Google Inc., 872 F. Supp. 2d 974 (N.D. Cal. 2012). The jury also rejected Oracle’s patent claims.
Id. at 1368.
Google, Inc. v. Oracle America, Inc., 576 U.S. 1071 (2015).
886 F.3d at 1210.
Justice Barrett, who had not yet been seated at the time of oral argument, took no part in the consideration or decision of the case.
Google LLC v. Oracle Am., Inc., 141 S. Ct. 1183, 1190 (2021).
Id. at 1199.
Id. at 1203.
Id. at 1203–04.
Id. at 1204.
Id. at 1204–05.
Id. at 1205.
Id. at 1206.
Id. at 1214.
Id. at 1215.
Id. at 1216.
Id. at 1220.
Id. at 1218.
Google, 141 S. Ct. at 1202.
48 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands have adopted the Uniform Trade Secrets Act. Of the two remaining holdouts, North Carolina applies a similar definition to the UTSA, while under New York law, courts apply a six-factor balancing test which weighs largely identical considerations, including the extent to which the information is known inside and outside of a business, the extent of secrecy measures, the value of the information, and the ease or difficulty for others to acquire or duplicate the information. See Ashland Mgmt. Inc. v. Janien, 624 N.E. 2d 1007, 1013 (N.Y. 1993).
The Defend Trade Secrets Act of 2016, codified at 18 U.S.C. § 1836et seq.
See, e.g., Automotive Data Sols., Inc. v. Directed Elecs. Canada, Inc., No. 18-cv-1560, 2018 WL 4742288, at *3–4 (C.D. Cal. Jul. 16, 2018) (finding that plaintiff had adequately pled that machine code constituted a trade secret despite distribution for sale of software program embodying it).
Fin. Info. Techs. LLC v. iControl Sys., USA, LLC, No. 17-cv-190, 2020 WL 5491376, at *1 (M.D. Fla. Aug. 10, 2020).
Motorola Sols., Inc. v. Hytera Comm’s Corp., 436 F.Supp.3d 1150, 1163–66 (N.D. Ill. 2020).
Broker Genius, Inc. v. Zalta, 280 F.Supp.3d 495, 517–523 (S.D.N.Y. 2017).
See Capricorn Mgmt. Sys., Inc. v. Gov’t Employees Insurance Co., No. 15-cv-2926-SRH-SIL, 2020 WL 1242616, at *9 (E.D.N.Y. Mar. 16, 2020) (“Even if [the software] was a trade secret, it lost the nomenclature by virtue of Capricorn’s copyright filings.”)
Intelum Co., LLC v. Nat’l Univ. of Singapore, 371 F.Supp.3d 864, 882–83 (W.D. Wa. 2019).
See Alice Corp. v. CLS Bank Intern., 573 U.S. 208, 222 (2014) (noting that the Court had previously found claims of a software patent were patent-eligible “because they improved an existing technological process, not because they were implemented on a computer”).
Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336–37 (Fed. Cir. 2016).
PersonalWeb Techs. LLC v. Google LLC, No. 5:13-cv-01317-EJD, 2020 WL 520618 at *12 (N.D. Cal. Jan. 31, 2020) (appeal filed)
Management Sci. Assocs. V. Datavant, Inc., No. 20-cv-0502-CFC, -- F. Supp. 3d --, 2020 WL 7771156, at *7 (D. Del. Dec. 30, 2020).
See Domo, Inc. v. Grow, Inc., No. 17-cv-812, 2018 WL 217937, at *2, *4 (D. Utah May 10, 2018).
See Lepton Labs, LLC v. Walker, 55 F.Supp.3d 1230, 1239–40 (C.D. Cal. 2014).
DisputeSuite, LLC v. Credit Umbrella Inc., No. 14-cv-6340, 2016 WL 6662722, at *4 (C.D. Cal. Apr. 25, 2016).
Parker Waichman LLP v. Gilman Law LLP, No 12-cv-4784, 2013 WL 3863928, at *4 (E.D.N.Y. Jul. 24, 2013).
Smartling, Inc. v. Skawa Innov. Ltd., 358 F. Supp. 3d 124, 147–150 (D. Mass. 2019).
17 U.S.C. § 301(a) (“all... rights that are equivalent to any of the exclusive rights within the general scope of copyright... are governed exclusively by this title”). The exclusive rights in the Copyright Act include the right to reproduce, adapt or prepare derivative works, distribute, or publicly perform or display a work. Id. at § 106.
See Guy A. Rub, Copyright Survives: Rethinking the Copyright-Contract Conflict, 103VA. L. Rev. 1141, 1145–47 (2017); see generally id. (discussing the history of the federal copyright preemption doctrine and how different circuits have addressed conflict between the two bodies of law).
See Sega Enters. Ltd. v. Accolade, Inc., 977 F.2d 1510, 1527–28 (9th Cir. 1992).
See, e.g., Neon Enter. Software, LLC v. Int'l Bus. Machines Corp., No. A-09-CA-A, 2011 WL 2036674, at *1–2 (W.D. Tex. May 24, 2011); Hireguru, LLC v. McKay, No. 3:16-CV-01669-MBS, 2016 WL 4536344, at *3 (D.S.C. Aug. 31, 2016); Frontline Test Equip. v. Greenleaf Software, 10 F. Supp. 2d 583, 591–93 (W.D. Va. 1998).
Notable Trademark Decisions, June 2021
By: Scott Greenberg and Anna Antonova
T.T.A.B. Clarifies that the Mark “CLEAR” for Goods that Are Not Clear Is Deceptively Misdescriptive
In a pair of almost-identical decisions, the Board affirmed the refusal to register the trademark CLEAR for bags and related goods, clothing, and footwear that were not, in fact, clear. Although two separate decisions were issued, one for each application, the Board’s analysis was the same.
Dolce Vita Footwear, Inc. (“Dolce Vita”) applied to register the character mark CLEAR on the Principal Register for, inter alia, bags (Serial No. 88554722), and for, inter alia, footwear, lingerie, and women’s clothing (Serial No. 88554717). In re Dolce Vita Footwear, Inc., 2021 U.S.P.Q.2d 479 (T.T.A.B. Apr. 29, 2021) [hereinafter Dolce Vita I]; In re Dolce Vita Footwear, Inc., 2021 U.S.P.Q.2d 478 (T.T.A.B. Apr. 29, 2021) [hereinafter Dolce Vita II]. Dolce Vita’s applied-for marks are the same, and the applications differ only in the goods claimed. Further, both applications were amended with a disclaimer to exclude transparent goods.
The initial applications did not disclaim transparent products and were refused as merely descriptive of the goods being claimed. Dolce Vita I, at *2; Dolce Vita II, at *2. The Examining Attorney relied on the dictionary definition of “clear” as “[e]asily seen through; transparent.” Dolce Vita I, at *2; Dolce Vita II, at *2. The Examining Attorney further reasoned that the world “clear” is commonly used to describe a feature or attribute of bags, footwear, or clothing that consumers would reasonably believe to be clear. Dolce Vita I, at *2; Dolce Vita II, at *2.
Dolce Vita appealed the refusals, claiming that its collection does not include transparent items. Dolce Vita I, at *3; Dolce Vita II, at *3. It additionally amended both of its applications to expressly disclaim transparent goods. Dolce Vita I, at *3; Dolce Vita II, at *4. The Examining Attorney refused registrations again, reaffirming its mere descriptiveness refusal, and offering an alternative ground for refusal that the trademark is deceptively misdescriptive of the identified goods. Dolce Vita I, at *3; Dolce Vita II, at *4.
Dolce Vita appealed to the Board. The board established that a mark is deceptively misdescriptive of the identified goods if (1) it misdescribes a quality, feature, function or characteristic of the goods or services with which it is used; and (2) consumers would be likely to believe the misrepresentation. Dolce Vita I, at *9; Dolce Vita II, at *11. The first part of the test determines whether the mark is “misdescriptive,” meaning it is “merely descriptive. . . .of a significant aspect of the goods or services which the goods or services plausibly possess but in fact do not.” Dolce Vita I, at *9; Dolce Vita II, at *11. The Examining Attorney argued that consumers are likely to think that “clear” refers to a feature of the bags, footwear, or clothing. This is plausible, and even likely, because fashion magazines and websites have been promoting the “clear” trend as seen on fashion show runways and worn by celebrities. Dolce Vita I, at *6-9; Dolce Vita II, at *6-10. In fact, and many producers of clothing, footwear, and bags have been offering clothing, footwear, and bags that are transparent or contain transparent elements; often these products are described as “clear” and labeled as such at the point of sale. The Examining attorney provided examples of such articles and screenshots of such products being offered for sale. Dolce Vita I, at *6-9; Dolce Vita II, at *6-10.
The Board found that because consumers would plausibly believe that Dolce Vita’s goods sold under the mark CLEAR would be transparent or include transparent features, but, in fact, none of Dolce Vita’s goods are transparent, the mark is misdescriptive in relation to the applied-for goods. The fact that none of Dolce Vita’s goods marketed under the trademark CLEAR would be transparent is conclusively derived from the fact that Dolce Vita expressly disclaimed the mark for use in connection with transparent goods. Dolce Vita I, at *10-11; Dolce Vita II, at *12. The Board explains that this disclaimer is not sufficient to dispel misdescriptiveness, because consumers would not know that transparent products are excluded from registration and may continue to expect goods under the CLEAR trademark to be transparent. Dolce Vita I, at *11; Dolce Vita II, at *13.
Furthermore, the Board states that an applicant cannot “avoid a finding of deceptive misdescriptiveness by excluding from its identification the very characteristic that its mark is misdecribing.” Dolce Vita I, at *11; Dolce Vita II, at *13.In this case, “clear “ does not have other meanings when used in connection to the goods at issue. Moreover, the Board states that the fact that a word has other meanings in different contexts is not sufficient to overcome a descriptiveness or misdescriptiveness refusal: “so long as any one of the meanings of a term is descriptive [or misdescriptive], the term may be considered to be merely descriptive [or misdescriptive].” Dolce Vita I, at *11-12 (alterations in original); Dolce Vita II, at *13-14 (same). Because consumers would expect Dolce Vita products under the trademark CLEAR to be transparent and these products are missing this attribute, the Board found that CLEAR for bags (and related products), footwear, and clothing (and related products) that are not transparent is misdescriptive, and satisfies the first part of the inquiry.
The second part of the analysis is the reasonably prudent consumer test, or whether consumers are likely to believe the misrepresentation. Dolce Vita I, at *12; Dolce Vita II, at *14. The Board agreed with the Examining Attorney that, because these types of goods are often described to the relevant consumer as transparent or “clear” in reference to a characteristic of the goods, and because of the popularity of the “clear” trend, consumers are likely to believe that goods marketed under the trademark CLEAR would be, in fact, clear or transparent. Dolce Vita I, at *12; Dolce Vita II, at *14.
Dolce Vita argued that a reasonably prudent consumer would not be deceived, because any misunderstanding would be negated before the sale occurs. Because the consumer would visually inspect the products before purchasing, they would realize that these products are not actually transparent. Dolce Vita I, at *14; Dolce Vita II, at *15-16. The Board rejected this argument because products may be promoted in marketing channels without images, including by word-of-mouth, print outlets, and social media. Dolce Vita I, at *14; Dolce Vita II, at *16. Without a visual, a consumer wishing to keep up with the popular “clear” trend would believe that goods marketed under the CLEAR trademark would conform to the trend. The Board stated that the likelihood of deception in the presale discussion and promotion of the goods is sufficient to find a mark deceptively misdescriptive. Dolce Vita I, at *14; Dolce Vita II, at *16.
Finding both elements of the deceptive misdescription test met, the Board affirmed the Examining Attorney’s refusals to register the marks.
In re Dolce Vita Footwear, Inc., 2021 U.S.P.Q.2d 478 (T.T.A.B. Apr. 29, 2021) (precedential); In re Dolce Vita Footwear, Inc., 2021 U.S.P.Q.2d 479 (T.T.A.B. Apr. 29, 2021) (precedential). [AA].
TTAB Cancels Registration For Nonuse – Registrant Neither Used Mark Herself Nor Convincingly Proved Her Entitlement to Rely on Earlier Use By Alleged Predecessor
In July 2018, Respondent Irina Kozodaeva (“Kozodaeva”) filed a U.S. trademark application, based on intention to use the following mark in commerce under Section 1(b):
in connection with the following goods in Class 9:
Apparatus for recording, transmitting and reproducing sound and images; Computer operating software; Computers; Data processing apparatus; Microscopes and their parts; Nautical and photographic apparatus and instruments, namely, underwater housings for cameras, underwater enclosures for cameras and underwater enclosures for photographic lenses; Optical apparatus, namely, a non-lethal security device that uses a light source to detect, warn, repel, temporarily blind, disorient, nauseate, disable, confuse, debilitate, stun, subdue, stop, or incapacitate persons or animals; Scientific apparatus and instruments for measuring relative DNA, RNA and protein and parts and fittings therefor; Transistors; Scanning probe microscopes.
Kozodaeva filed a statement of use on March 10, 2019, claiming a date of first use and first use in commerce of January 8, 2019, and the registration issued. Petitioner NT-MDT LLC (“NT-MDT”), a Russian limited liability company, petitioned to cancel the registration on the following grounds: (i) nonuse of the mark in commerce as of the time that Kozodaeva filed her statement of use; (ii) Kozodaeva’s lack of ownership of the mark when she filed the application; (iii) lack of a bona fide intention to use the mark as of the application’s filing date; (iv) likelihood of confusion with a prior common law trademark right; and (v) fraud. Kozodaeva denied NT-MDT’s claims and raised the affirmative defense of abandonment with regard to the likelihood of confusion claim. In a precedential decision, the Trademark Trial and Appeal Board held that NT-MDT met its burden on the nonuse claim, and the Board granted cancellation based on that claim. In view of this determination, the Board declined to consider NT-MDT’s other grounds for cancellation or Kozodaeva’s abandonment defense which only pertained to those other grounds. NT-MDT LLC v. Kozodaeva, 2021 U.S.P.Q.2d 433 (TTAB April 15, 2021).
Entitlement to a Statutory Cause of Action
The Board held that NT-MDT sufficiently established its entitlement to bring a statutory cause of action (formerly known in Board jurisprudence as “standing”) by proving that it was a competitor of Kozodaeva. Specifically, NT-MDT proved that it currently manufactures atomic force microscope (AFM) products under the NT-MDT mark and ships the products to its corporate affiliate NT-MDT America for distribution in the United States. Id. at *10.
Nonuse in Commerce
The parties stipulated to the Board’s determination of specified issues, based on the parties’ briefs, declarations and evidentiary exhibits, pursuant to the Board’s Accelerated Case Resolution (ACR) procedure. Id. at *5. One issue to be determined was NT-MDT’s claim that the registered mark was not actually used in commerce at the time of Kozodaeva’s filing of her statement of use. The Board noted that the party asserting such a claim must prove that “the defendant did not use the mark with the goods or services listed in the registration within the time for filing the statement of use.” Id. at *14.
In its petition to cancel, NT-MDT alleged Kozodaeva’s nonuse at the time of filing of the statement of use, but failed to also allege nonuse during the remainder of the period of time that Kozodaeva had for filing the statement of use. The Board noted that this would generally constitute a failure to state a claim upon which relief can be granted. However, the Board also noted that, in this case, the parties stipulated to the Board’s determination of the issue of Kozodaeva’s use or nonuse of the mark both in connection with the statement of use “and any time beyond the filing date of the statement of use. The Board therefore held that the legally pertinent issue of nonuse was tried by the express consent of the parties. Id. at *15.
On the issue of nonuse, the parties stipulated that Kozodaeva had not used the mark in commerce in connection with any products at the time of (a) her claimed dates of first use, (b) the filing of the statement of use, or (c) thereafter up through the date of registration. Id. at *15-16. The Board noted that these stipulated facts “would appear to seal [NT-MDT]’s victory on the nonuse claim.” Id. at *16. However, the Board also noted that Kozodaeva, as part of her defense, moved the Board for permission to amend her registration to assert an earlier date of first use in commerce. Specifically, Kozodaeva claimed to be entitled to an amended date of first use in January 1999 based on earlier United States use of the registered mark by an alleged predecessor in interest, namely CJSC NT-MDT, a Russian company that was the original entity in the corporate group of petitioner NT-MDT and the original user of the NT-MDT trademark. Id. at *3, *12, *16 and *24. The Board’s opinion (at *3, n.4) notes that the parties refer to this entity interchangeably as “CJSC NT-MDT” and “NT-MDT CJSC”, and the Board does the same in its opinion (this entity is hereinafter referred to as “CJSC NT-MDT”).
The Board noted that Trademark Rule 2.173(b) (37 C.F.R. § 2.173(b)) requires that a request to amend a registration be accompanied by a filing fee and a supporting verified statement on behalf of the registrant. Even though Kozodaeva failed to comply with either of these requirements, the Board proceeded to consider the merits of her request because it had been fully briefed by the parties. Id. at *20.
Regarding the merits, the Board noted that a request to amend a registration to set forth an earlier date of first use faces a “heavy burden” of proof by “clear and convincing evidence” that the registrant is entitled to rely on the earlier date. Id. Here, the Board held that the agreements relied upon by Kozodaeva do not meet this heavy burden to establish, clearly and convincingly, that she is the successor in interest to any U.S. rights of CJSC NT-MDT with regard to the registered NT-MDT and Design mark. Id. at *30. The Board reached this conclusion based on the following findings regarding these documents:
April 2018 Ownership Transfer Agreement
The first asserted transfer document relied upon by Kozodaeva was an “Ownership Transfer Agreement” dated April 2, 2018 between NT-MDT Europe B.V., a company within Petitioner NT-MDT’s corporate group, and Techno-NT, Kozodaeva’s sole proprietorship. This agreement was signed on behalf of NT-MDT Europe B.V. by Alexander Bykov as its Director and Owner. Kozodaeva also submitted, as supporting evidence in the cancellation proceeding, a declaration of Alexander Bykov. Among the “Assigned Property” that the April 2, 2018 agreement assigned from NT-MDT Europe B.V. to Kozodaeva’s sole proprietorship was the subject NT-MDT and Design trademark “including unlimited rights to use this Trademark in the United States of America (using since 1999)…”. The Board held that this was sufficient to establish the transfer of “any rights that NT-MDT Europe B.V. had to the mark to Techno NT, Respondent's sole proprietorship.”Id. at *24.
However, the Board held that it was necessary to determine the nature and source of rights in the mark that NT-MDT Europe had in April 2018 that it could transfer to Kozodaeva’s company. In this regard, Alexander Bykov stated in his declaration that, in October 2008, he, acting as an officer of the original user of the mark CJSC NT-MDT, gave NT-MDT Europe B.V. the right to use the subject mark in the United States and other jurisdictions. The document in question from October 2008, which Alexander Bykov identifies in his declaration as a “license,” states that NT-MDT Europe B.V. “has fully rights to use” the subject trademark in the U.S. The foregoing, as well as the absence of any mention of transfer of goodwill in the October 2008 document, led the Board to conclude that it was a license to use the mark in the U.S. and not a transfer of ownership rights to NT-MDT B.V. Id. at *26. Moreover, Petitioner NT-MDT submitted a declaration of Victor Bykov, who was a co-owner of CJSC NT-MDT and is presently a manager of NT-MDT (Id. at *8), in which Victor Bykov states that CJSC NT-MDT never assigned the original user’s common law U.S. rights in the subject mark to NT-MDT Europe B.V. Based on the totality of the evidence, the Board found Kozodaeva “has not established through clear and convincing evidence that she obtained rights to the registered mark through the [April 2, 2018] Ownership Transfer Agreement and may not rely on the Ownership Transfer Agreement to claim a use date earlier than that identified in her registration.” Id. at *26-27.
Transfers from Russian Bankruptcy Proceeding of CJSC NT-MDT
In 2015, CJSC NT-MDT, the original user of the subject mark, filed for bankruptcy in Russia. According to Kozodaeva, in 2019, based on discussions with her husband’s sister, Anastasia Aleksandrovna Yakovleva, Kozodaeva believed that NT-MDT CJSC had included rights to the trademark “NT-MDT” among its scheduled assets in the bankruptcy proceeding, possibly including the U.S. trademark rights that Kozodaeva thought she had obtained in April 2018 from NT-MDT Europe B.V. Kozodaeva therefore asked Ms. Yakovleva to assist in obtaining relevant assets from the bankruptcy estate. Id. at *22.
Ms. Yakovleva’s efforts resulted in two transfer documents that Kozodaeva offered into evidence, a March 7, 2019 Bankruptcy Purchase Agreement by which the bankruptcy trustee sold certain assets to Ms. Yakovleva, and a March 24, 2019 Trademark Purchase Agreement from Ms. Yakovleva to Techno-NT, Kozodaeva’s sole proprietorship.
The March 7 2019 Bankruptcy Purchase Agreement included the following two provisions:
1.3. The assets subject to sale hereunder shall be sold as Lot l and they shall include: ... intangible assets, fixed assets, financial investments of the debtor. All property assets are listed in Annex 1 hereto.
1.5 Acquisition by the Buyer of a property of the Closed Joint Stock Company "Nanotechnology-MDT" (NT-MDT CJSC) gives him the right to exclusively use the designs, patents, trademarks of the Closed Joint Stock Company "Nanotechnology MDT" (NT-MDT CJSC) for the implementation of entrepreneurial activities, including the development of equipment and control software and use and register the trademark NT-MDT outside the Russian Federation - in the United States of America (use since 1999), European Union (use since 1996), in China (use since 2000) and India (use since 1999). Id. at *27-28.
Regarding this document, the Board held that the Annex 1 to the agreement was essentially the same as the official schedule of the company’s assets in the bankruptcy proceeding, both of which referenced the mark of Russian Trademark Registration Number 188978, which is a design mark essentially the same as the design element of the U.S. registration at issue, but without any words. Moreover, the Board held that U.S. trademark rights, although mentioned in the March 7, 2019 agreement, were not identified in the official list of bankruptcy assets. “Because of these omissions, we find that Ms. Yakovleva did not obtain rights to the mark of the ’336 registration [the subject U.S. registration and mark] through the Bankruptcy Purchase Agreement, and that Kozodaeva may not claim rights to her registered mark through the Bankruptcy Purchase Agreement.” Id. at *28.
Regarding the March 24, 2019 Trademark Purchase Agreement from Ms. Yakovleva to Kozodaeva’s sole proprietorship, it transferred to Kozodaeva rights, both in and outside of Russia including in the U.S., for the trademark of Russian Reg. No. 188978, which, as noted above, consisted of the design element but not the word element of the subject U.S. registration. Therefore, the Board found that Kozodaeva “has not established that she obtained rights to her mark through the Trademark Purchase Agreement.” Id. at *29.
The Board therefore granted NT-MDT’s petition to cancel on the ground of nonuse and, in view of that disposition, declined to consider NT-MDT’s other claims or Kozodaeva’s defenses pertaining to those other claims. NT-MDT LLC v. Kozodaeva, 2021 U.S.P.Q.2d 433 (TTAB April 15, 2021) (precedential).[SG]
Failure to Disclose Abandonment of a Mark in Relying on It for Priority Date and as Evidence of Acquired Distinctiveness of a Later Mark May Constitute Fraud on the USPTO, T.T.A.B. Says
Respondent is the owner of two trademark registrations for “insurance brokerage in the fields of disability and life insurance” in International Class 36. Issued on April 25, 2006, is the use-based design mark DOCTOR DISABILITY with a stethoscope design, with “DOCTOR DISABILITY” disclaimed (Registration No. 3084018) (“Stethoscope Mark”), depicted below.
Respondent’s second mark, a standard character mark DOCTOR DISABLITY, disclaiming “DISABILITY,” issued on May 7, 2019 (Registration No. 5744284). Issued on the basis of use, the application claimed acquired distinctiveness and a first-use date of February 5, 2004. As evidence that the character mark has acquired distinctiveness, Respondent relied on its ownership of the registered Stethoscope Mark, which, Respondent argued, is the same mark for sufficiently similar goods and services. DrDisabilityQuotes.com, LLC v. Krugh, 2021 U.S.P.Q.2d 262, at *3 (T.T.A.B. Mar. 5, 2021) Respondent further represented in its application for the character mark that the mark has become distinctive through substantially exclusive and continuous use in commerce for at least five years. Id.
Petitioner purports to be a competitor of Respondent and asserts common law rights in the mark DrDisabilityQuotes.com. Id. at *6. It sought to cancel the registration of the Doctor Disability Mark alleging that its registration is a result of fraud on the USPTO and also claiming likelihood of confusion with its own mark. Id.
In its fraud claim, Petitioner argues that Respondent falsely represented in its application to register the Doctor Disability Mark that it had exclusive and continuous use of the mark for five years. Id. at *4. It claimed that Respondent had abandoned the Stethoscope Mark, on which the acquired distinctiveness of the Doctor Disability Mark relies. Id. at *4, 8-9. Accordingly. Respondent cannot claim five years of continuous use in commerce, and a statement claiming such continuous use is false. Id. at *8-9. This statement was made intruder to obtain a registration for the mark and it is was material to the Examining Attorney’s determination regarding registrability of the Doctor Disability Mark. Id.
Respondent did not file an answer to the cancellation petition, but rather filed a motion to dismiss for failure to state a claim upon which relief can be granted pursuant to Fed. R. Civ. Pro 12(b)(6). In response to the fraud claim, Respondent argues that the alleged misrepresentations would not have been material to the registration of its marks and would have no bearing on the Examiners’ decisions.
The Board explains that materiality of a statement made in an application is material if the statement is critical to the examining attorney’s decision to approve or refuse a mark. Id. at *10. Here, Respondent did not elaborate why it thinks its statements would not be material. Id. The Board agreed with the Petitioner, however, that the determination of acquired distinctiveness was a key part of the Examining Attorney’s analysis of this mark. Id. at *10.11-12. Pursuant to TMEP § 1202.02(d), had the Examining Attorney believed the applied-for mark to be inherently distinctive (and therefore, not require proof of acquired distinctiveness), they would inform the Respondent (applicant) that the statements regarding acquired distinctiveness may be withdrawn, as the registration can issue as inherently distinctive. Id. at *10-11.
However, this did not occur in this case, and therefore, it can be presumed that the Examining Attorney believed the applied-for mark required a showing of acquired distinctiveness, and relied on the truth of these statements in considering its registrability. Id. at *11-12.If these statements were not true, Respondent’s ability to establish acquired distinctiveness on its theory of continuous use based on the prior registration would be in doubt, and the application may have been refused on the grounds that the applicant could not establish five years of continuous use. Id.
Specifically, Petitioner claimed that Respondent has not used the Doctor Disability Mark in commerce, or anywhere, since February 2004 and only started to use it after abandoning the Stethoscope Mark (around August 2018 when it filed its Doctor Disability Mark application). Id. at *8. According to the Petitioner, Respondent committed fraud on the USPTO by failing to disclose that it stopped using and abandoned its Stethoscope Mark on which the registration of the Doctor Disability Mark relied. Id. at *8-9. Although the Board did not weigh in on the merits of the fraud claim, it agreed that the statements regarding the acquired distinctiveness were material to the Examining Attorney’s determination. Id. at *10. 11-12. Therefore, the Board ruled in favor of the Petitioner that it had established a claim and denied Respondent’s motion to dismiss. Id. at *12.
In response to the likelihood of confusion claim, Respondent asserted it had priority date much earlier than Petitioner’s asserted priority date of November 2015. Id. at *13. But Respondent asserted a constructive priority date of 2006 because of the registration of the Stethoscope Mark. Id. at *13-14. It claimed that the priority date of the first mark carried over through tacking to the Doctor Disability Mark. Id. Accordingly, Respondent moved to dismiss the likelihood of confusion claim.
The Board rejected Respondent’s argument as premature at this stage of the proceedings. Id. at 14. The Board explained that Rule 12(b)(6) only assesses the legal sufficiency of the allegations, not the merits. Id. Tacking is a question of fact that requires pleading, discovery, and proof at trial; it is not a proper inquiry for a motion to dismiss. Id. Here, the Respondent has not pled tacking because it only filed a motion to dismiss, rather than an answer to the petition. Id. at *10. Therefore, the Board found that Petitioner has sufficiently pled the likelihood of confusion claim, and Respondent’s motion to dismiss was denied. Id. at *15.
DrDisabilityQuotes.com, LLC v. Krugh, 2021 U.S.P.Q.2d 262, (T.T.A.B. Mar. 5, 2021) (precedential). [AA]
Prior Board Decision Affirming Descriptiveness Refusal Precludes New Application For Same Mark and Goods, Notwithstanding Applicant’s New Arguments Against Descriptiveness
SolarWindow Technologies, Inc. (“SolarWindow“) applied to register the mark POWERCOATINGS on the Principal Register for “electricity generating coatings applied to various substrate surfaces for use in renewable energy, namely, chemicals for use in connection with solar cells” in International Class 1. The Examining Attorney refused registration on two grounds: (1) that the mark is merely descriptive under Section 2(e)(1) of the Trademark Act, 15 U.S.C. § 1052(e)(1), and (2) that the doctrine of res judicata precludes re-litigation of the descriptiveness issue in view of a prior adjudication by the Trademark Trial and Appeal Board involving the same mark and goods. In a precedential decision, the Board affirmed the refusal on res judicata grounds, holding that SolarWindow was precluded from re-litigating the issue of descriptiveness. In re SolarWindow Technologies, Inc., 2021 U.S.P.Q.2d 257 (T.T.A.B. March 5, 2021).
SolarWindow’s prior application to register the POWERCOATINGS mark in connection with the same goods was refused on the ground of mere descriptiveness. SolarWindow appealed the refusal to the Board, who affirmed the refusal on July 13, 2016. SolarWindow did not appeal that decision, and the prior application was abandoned on October 17, 2016.
Less than two years later, SolarWindow filed the present application for the same mark and goods. In response to the descriptiveness refusal in the new application, SolarWindow made certain arguments, together with supporting evidence, that it hadn’t asserted or submitted in the first application, namely that POWERCOATINGS is not merely descriptive because: (1) it is similar in appearance and sound to “powder coating,” and thus (2) the proposed mark will be “associated with, or used in conjunction with, the term 'powder coating' in the powder coating industry.” However, the Board noted that SolarWindow did not specify “how these ‘additional facts’ present new circumstances or whether the evidence it relies upon was unavailable when the Board previously adjudicated the issue of mere descriptiveness of Applicant's mark in the Prior Decision.” Id. at *4-5.
The doctrine of res judicata (also known as claim preclusion) bars a second suit involving the same parties (or their privies) and the same cause of action, where there has already been a judgment on the merits in a prior suit. The Board noted that its primary reviewing court, the Court of Appeals for the Federal Circuit, has held that res judicata applies where a trademark applicant appeals from a refusal which is affirmed on appeal, and then re-files for the same mark and goods where there has been no change in the applicable facts or circumstances. Id. at *5 (citing In re Bose Corp., 476 F.3d 1331, 81 USPQ2d 1748, 1752 (Fed. Cir. 2007)). In Bose, the applicant’s first application was refused on the ground of functionality (Id. at n.16), and the Federal Circuit, when reviewing the refusal of the second application on res judicata grounds, rejected the applicant’s argument that its new promotional materials constituted a changed circumstance sufficient to prevent the application of the doctrine of res judicata. Id. at *8.
Applying these rules of law to the present case, the Board held that SolarWindow’s new arguments “are, at best, alternative arguments why it believes its mark is not merely descriptive of its goods” and that SolarWindow failed to show that its new argument, i.e. possible consumer confusion between the proposed mark POWERCOATINGS and the term “powder coating”, was not an available argument during the prosecution of the prior application. Id.
“In other words, [SolarWindow] does not demonstrate the required material change of circumstances or conditions merely by bringing up a new argument which could have been made during the prosecution of [SolarWindow’s] Prior Application. It was incumbent upon [SolarWindow] to put its best foot forward by presenting during prosecution of the Prior Application all arguments that it believed could overcome the descriptiveness refusal.” Id. at *9 (emphasis in original).
Therefore, the Board held that res judicata applied to preclude re-litigation of the descriptiveness issue, and affirmed the Examining Attorney’s refusal on that basis. In re SolarWindow Technologies, Inc., 2021 U.S.P.Q.2d 257 (T.T.A.B. March 5, 2021) (precedential). [SG]
BY: DALE CARLSON*
Giles S. Rich [NYIPLA President. 1950-51] was a preeminent member of our Association for good reason. He was thrust into national prominence by virtue of his testimony before Congress on our Association's behalf regarding need for legislative reform to U.S. patent law.
At the behest of the now-defunct National Council of IP Law Associations, Giles was invited to co-author the Patent Act of 1952. In that capacity, he became the motive-force behind the nonobviousness standard of invention embodied in Section 103 of the Act.
There was a long hiatus between enactment of that standard and its review by SCOTUS in 1966. In the meantime, Giles had become Judge Rich, sitting on the bench of the Court of Customs and Patent Appeals, and its successor, the Federal Circuit Court of Appeals, for over four decades.
Prior to SCOTUS's consideration of the landmark case of Graham v. John Deere, and a couple of companion cases, Judge Rich gave a speech on the pre-existing vague concept of "invention", as replaced by Section 103. The speech was delivered in 1964 at a Charles F. Kettering Award Dinner for the Eighth Annual Public Conference of the Patent, Trademark and Copyright Research Institute. It became known as his "Kettering Speech".
Here's an intriguing back-story. A well-know patent lawyer named Tom Arnold was teaching patent law at the University of Houston then. Prof. Arnold got wind that one of his students, Michael M. Maupin, was accepted to clerk for Justice Tom Clark at the end of the academic year. He knew, of course, that review of the Section 103 standard of invention was wending its way through the federal courts system then.
Prof. Arnold put two-and-two together. He announced in his class that the only way students would pass his course would be if the memorized by heart the Kettering Speech. He said this over and over in subsequent classes to make sure that Mr. Maupin and fellow students soaked-up the Speech.
Not long after, the then Solicitor General, Archibald Cox, decried that fact that SCOTUS had not reviewed a single case on the standard for invention since 1950, even though it had reviewed a large number between 1925 and 1949.
Justice Clark's newly-minted law clerk informed him that "[t]he SG really wants the Court to … have a sort of one day orgy of patent arguments to celebrate the end of a thirteen year dry spell."
Graham, together with its companion cases, did put an end to the dry spell. It also put an end to the impossible-to-meet "flash of genius" test established by the Cuno case in 1941. Justice Clark authored the Graham and companion Opinions. Perhaps they were actually penned by his law clerk.
What is the object lesson here? Maybe it took judges like Judge Rich, teachers like Prof. Arnold, and newly-minted lawyers like Mr. Maupin, working in concert, to effect positive change to patent law. In other words, perhaps it took a village.
The Graham standard of invention stood the test of time for many years. SCOTUS upset the applecart in 2007 with its Opinion in KSR. That Opinion introduced "common sense of the fact finder" as a new factor for nonobviousness. Hindsight reasoning, long after the date of invention, appears to now reign supreme. Perhaps we need another village.
By way of post-script, Justice Clark was one of only two Supreme Court Justices to give a keynote address at our Judges Dinner. At 93 years old, Judge Rich gave his last one at the 1997 Dinner.
Hoping to see you next year at our Centennial Dinner!
* Mr. Carlson is an NYIPLA past president and current historian. His email is email@example.com.
"As Time Goes By - It Took a Village"
Fifteen years ago, the treatment of breast cancer was relatively uniform across patients. A patient with a suspected malignancy would be imaged and biopsied. Upon the diagnosis of breast cancer, she had the options of standard chemotherapy, radiation, and/or surgery to remove the tumor. If the tumor did not respond to chemotherapy or radiation, her prognosis was poor, and options for alternative treatments were few.
Today, this process looks dramatically different. The tumor is first genetically sequenced, and its mutation profile analyzed to inform the course of treatment. Depending on the genetic thumbprint of the tumor, the patient may be given targeted antibody therapies in conjunction with or following chemotherapy. If the primary therapies are effective and eliminate the tumor, she can take adjuvant therapies to reduce the chance of remission. If the primary therapies fail, there are second- and third-line treatments available. These and other advances have driven significant increases in breast cancer survival rates since 2006.
This trend is not unique to oncology. Thanks to innovations in genetic sequencing and molecular targeting, therapies in medicine are increasingly targeted to the specific genetic, metabolic, and molecular profile of the individual being treated. Precision medicine promises to transform healthcare by enabling earlier detection of disease; sharper calculation of risk and prognosis; more informed selection of drugs or therapies from the range of treatment options; and better monitoring of disease course and patient response. It promises, in short, a revolution in patient care.
However, the future of precision medicine relies heavily on innovation in diagnostics. Diagnostics is a field encompassing all the tools, technologies, and tests that physicians use to interpret patient data and inform clinical decisions. New methods of diagnosis are essential for the translation of medical discoveries into better clinical outcomes, but their patentability varies widely between countries. In Europe, methods of diagnosis are generally patentable so long as they are based on samples and not practiced directly on the human body. In the US, methods of diagnosis may be patentable if they either (a) use unconventional or nonroutine techniques, or (b) involve an additional step, usually one of treatment. Finally, in Japan, methods of diagnosis and methods of treatment are unpatentable subject matter, but may be claimed in other ways. These differences in patentability regimes have important implications for the future of precision medicine.
This paper will evaluate the three different regimes for diagnostic method patents in Europe, the US, and Japan.It will first explain what is and is not patentable subject matter in each regime, with a focus on recent case law from the Federal Circuit that has complicated the patentability question for diagnostics in the US. It will then conduct case studies of diagnostic inventions patented in more than one system to demonstrate the drafting strategies available to inventors seeking to protect diagnostic inventions globally, and the market dynamics that play out as a result. Finally, this paper will assess the broader implications of these regimes for innovation in the diagnostics market, and will make recommendations to better protect diagnostic innovation globally and in the US.
I. Patentability Regimes
The European Patent Office (EPO) has a relatively liberal patenting regime for methods of diagnosis. Under Article 52 of the European Patent Convention,“patents shall be granted for any inventions, in all forms of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.” Similar to the USPTO’s examination guidelines, patent claims that relate solely to discoveries or scientific theories are not regarded as “inventions” eligible for patenting. However, the application of a discovery to a practical use is regarded as patent-eligible, as the practical use confers the needed “technical effect” that qualifies the invention for patenting. Methods of diagnosis are therefore patentable in Europe, because they involve the practical application of a natural correlation or discovery to the diagnosis of disease.
There are some limits to the patentability of diagnostic methods under the EPC, but they are few. The EPC first excludes“diagnostic methods practised on the human or animal body,” but has clarified that those practiced on samples or images taken from the body are patent eligible. The EPC also excludes the use of human embryos for industrial or commercial purposes, but not for therapeutic or diagnostic purposes “which are applied to the human embryo and are useful to it.” Moreover, the EPC requires that the claimed method reach a final diagnosis; it cannot simply include the steps of information-gathering which precede diagnosis. So long as they comply with these three requirements, methods of diagnosis are broadly patentable in Europe.
B. United States
In the US, the patentability of diagnostic inventions is more complicated. Under 35 U.S.C.§ 101, abstract ideas, laws of nature, and natural phenomena are not patentable. Diagnostic inventions typically rely on an observed correlation or dose-response relationship. When the claimed invention is a platform, assay, instrument, or device used for diagnostic purposes, such patents generally pass muster under § 101. But patents that claim a method of diagnosis often strain the limits of the judicial exception for “laws of nature.” For this reason, the Federal Circuit has struggled to reach a clear consensus on the patentability of methods of diagnosis, and the Supreme Court has recently declined to resolve the matter. The uncertainty that remains interferes with the incentives for innovation in this field.
The framework for determining subject-matter eligibility, laid out by the Supreme Court in Mayo Collaborative Services v. Prometheus Labs, involves a two-step inquiry. First, the court asks whether the claimed invention is directed to one of the judicial exceptions (a law of nature, natural phenomenon, or abstract idea). If so, the court then asks whether the claim nevertheless contains an “inventive concept” that transforms the judicial exception into a patent-eligible application. The patent in Mayo, for example, claimed a method of optimizing the dosage of a thiopurine drug by tracking the relationship between metabolite concentrations in blood and adjusting the dosage accordingly. The Court considered this claim invalid, as it was directed to a law of nature and lacked an “inventive concept,” or an additional feature that would have transformed it into something more. The Court did not shed much light on what an “inventive concept” might look like in the field of diagnostics, though it suggested that “a new way of using an existing drug” might suffice.
Unsurprisingly, Mayo left many questions regarding the patentability of diagnostic methods unanswered. In Ariosa Diagnostics v. Sequenom, the Federal Circuit invalidated a patent for noninvasive diagnosis of fetal abnormalities by analysis of free-floating fetal DNA in maternal blood. The claims were directed to a natural phenomenon, according to the court (namely, the presence of fetal DNA in maternal blood), and the additional elements (the techniques used to amplify and detect the DNA) were well-understood, routine and conventional. As such, they were insufficient to transform the claims into a patentable invention.
Ariosa seemed to confirm the per se ineligibility of diagnostic methods for patent protection, unless they involve unconventional or nonroutine techniques. This alarmed stakeholders in the fields of precision medicine and diagnostics, and led to calls for change. Three years later, in Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, the Federal Circuit re-opened the door of patentability a crack. The patent in Vanda claimed a method of treating schizophrenia with iloperidone, where the dosage was to be adjusted based on the patient’s genotype. While the claim involved a natural relationship (e.g. the relationship between genotype and the risk of an adverse reaction), the court held that it was directed to a practical application of that relationship, rather than to the natural relationship itself. The court distinguished Mayo on the grounds that Mayo was not a treatment claim:Mayoinvolved a dosage adjustment secondary to a method of diagnosis, while Vanda involved an additional administration step as part of a method of treatment. This, according to the majority, was enough to push the Vanda patent into patent-eligible territory before reaching step 2 of the Mayo framework.
Vanda, among other recent Federal Circuit cases,reflects the growing strain placed upon the Mayo framework by diagnostic inventions. The Supreme Court declined a petition for certiorari in Vanda, but only after inviting the Solicitor General to weigh in on the petition. The Solicitor General recommended that the Court deny the petition, because the Federal Circuit reached the correct result. However, he noted the lack of clarity as to “how the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible can be reconciled with mechanical application of Mayo’s two-step framework.” For this reason, the Mayo framework, according to the Solicitor General, “warrants reconsideration.”
The Supreme Court also declined to hear the case of Athena Diagnostics v. Mayo Collaborative Services in 2020. The patent in Athena claimed a method of diagnosing neurological disorders by detecting autoantibodies found in a subgroup of patients. The Federal Circuit held the claims invalid at Mayo step 1, because they were directed to the discovery of a natural law (the prevalence of autoantibodies in certain patients), and only applied conventional techniques to detect that natural law. Unlike Vanda, the patent did not claim a method of treatment, and therefore was not considered an application of the natural law.
The Supreme Court’s denials of certiorari in Vanda and Athena have left theMayo framework intact for now. As it stands, diagnostic method patents that recite an additional treatment step seem to be per se patentable subject matter. Diagnostic method patents that do not recite an additional, affirmative step must involve unconventional or non-routine techniques in order to pass step 2 of Mayo. This conception is supported by recent decisions from the Federal Circuit and revised guidance from the USPTO on subject-matter eligibility. However, the current state of the law is far from clear, and the uncertainty surrounding the patentability of new diagnostic methods disincentivizes their development. Ultimately, in the words of Judge Newman, “[t]he loser is the afflicted public, for diagnostic methods that are not developed benefit no one.”
The patentability regime for diagnostic methods in Japan represents a more rigid approach, but one that may ultimately allow for greater patentability of diagnostic methods than in the US. According to the Japan Patent Office (JPO), methods of diagnosis of humans are not considered“industry applicable” inventions. The JPO defines methods of diagnosis as “methods of judging for the medical purposes the physical condition of a human body… such as conditions of diseases and physical health or the mental condition of a human body.”  The JPO also considers methods of therapy or treatment ineligible for patenting. Therefore, under JPO examination guidelines, a method of diagnosis does not become patent-eligible by reciting an additional treatment or administration step.
The JPO considers medical devices and medicines patentable. A method for controlling the operation of a medical device is also patentable, so long as it does not include either (i) “an action of a medical doctor (for example, a step where a medical doctor operates a device in order to provide medical treatment in accordance with a symptom)”; or (ii) “a step with an influence on the human body by a device (for example, the incision or excision of a specific site of patient’s body by a device or the irradiation of radiation, electromagnetic wave or sound wave by a device).” Moreover, methods of extracting, treating, and/or analyzing samples and data from the human body are patentable, so long as they do not include a step of diagnosis or treatment. For instance, “a method of examining the susceptibility of an individual to hypertension by determining his genotype at one locus and comparing it with a standard” is patentable. Likewise, “a method for judging sugar level in urine by dipping a test strip in a sample of collected urine and comparing that color with a reference sheet” is also patentable. If either of these claims included a step of diagnosis or treatment, however, these would be disqualified as patent-ineligible methods.
In light of these rules, an inventor seeking patent protection for a method of diagnosis in Japan has several options. As in the US and Europe, she could patent the product, instrument, or device used in her diagnostic method. She could also claim the method for controlling the operation of the medical device, without reciting any step involving the action of a doctor or a direct influence on the human body. If no device is involved, she could potentially rewrite the claim as a “second medical use claim”—by claiming, for example, “[Substance or Composition X] for use in the treatment of [Disease Y], wherein [dosage is adjusted based on concentration of Metabolite Z].” Alternatively, she could claim the method of extracting, analyzing, or treating the samples or data used for the diagnosis, without reciting a diagnostic or treatment step. Unlike the USPTO, the JPO does not require that the claims be directed to a practical application of an observed correlation or natural relationship. So long as they relate to a method of prediction or prognosis and include a step of data or tissue analysis, they are considered patent-eligible subject matter. These drafting approaches may not be viable for every inventor of a new diagnostic method, and as a result, some diagnostic inventions that would be patentable in Europe may fall through the cracks of Japan’s patentability regime. However, the JPO’s regime ultimately covers more diagnostic methods than the USPTO’s more restrictive Mayo framework, as will become clear from the case studies to follow.
II. Case Studies
The differences between the patentability regimes of the USPTO, EPO, and JPO are significant, but what do they mean for the inventor of a diagnostic method—and for the market more broadly? This section will conduct case studies of diagnostic inventions that have sought patent protection internationally. The first pair of case studies will reveal the drafting techniques available to patent applicants seeking protection for diagnostic methods in the US. The second pair of case studies will illustrate the limits of such drafting techniques under the more restrictive framework of the USPTO, and the impacts of these limits on the diagnostic market. Overall, these case studies will contextualize the rules of patentability in each system, and provide examples for further discussion in Part III.
A. Post-Vanda Drafting Techniques for Diagnostic Methods, and the Cost of an
Strategic drafting may confer some level of patentability for diagnostic methods in the US. Under the Mayo framework, methods of diagnosis may become patent-eligible if they are drafted as methods of treatment. So long as the patent recites an administration or treatment step like the patents in Vanda, then the USPTO considers it to be directed to a practical application of a natural relationship, and therefore patentable. Patent applicants seeking patent protection in the US for methods of diagnosis have modified their drafting strategies in response to Vanda. The following two case studies will demonstrate the viability of Vanda-type claim drafting for certain methods of diagnosis.
1. The Chugai Patents
The Chugai patents provide a good example of the Vanda-type drafting approach. These patents relate to a diagnostic finding that the blood level of plasmablasts (a type of immune cell) in patients with relapsing-remitting multiple sclerosis predicts their response to certain immunotherapies. The European and Japanese patents claim this as “[a] method for determining the therapeutic effect of an IL-6 inhibitor on a relapsing-remitting multiple sclerosis patient,” while the US patent claims it as “[a] method for determining the therapeutic effect of an IL-6 inhibitor… and treating the patient.” The European and Japanese patents only recite the steps of sample analysis and comparison to a standard, while the US patent recites an additional step of treatment with the IL-6 inhibitor. Therefore, under the Mayo framework, the Chugai method is still patentable, but must be limited by an additional step. This additional step is no small limitation: it means that anyone who markets a “multiple sclerosis plasmablast test” in the US will remain free from infringement liability, so long as they avoid administering the named drug to the patient. As a result, the protection afforded by the US Vanda-type patent is inadequate to protect the diagnostic test itself.
Interestingly, despite the differences between the EPO and JPO patentability regimes, the European and Japanese Chugai patents are roughly identical. The Chugai claim is patent-eligible in Japan as written because the JPO’s definition of “diagnosis” is quite narrow. Although the Chugai method is diagnostic in the sense that it concerns a method of interpreting patient data and informing treatment, it does not involve the primary diagnosis of a patient with a disease. Moreover, because the JPO considers methods of sample analysis and data analysis to be patent-eligible, the Chugai applicants did not need to limit their method claims with an additional step in order to render the invention patentable. This case study suggests that certain diagnostic methods may be more readily patentable in Japan than in the US.
2. The Genentech Patents
The Genentech patents provide another good example of the Vanda-typedrafting approach. Genentech discovered that certain genetic biomarkers in tumors predict a patient’s response to treatment with targeted immunotherapy (an OX40 agonist), and sought to patent this method of prediction. The European patent claims “[a] method for predicting responsiveness of a subject having cancer to an OX40 agonist treatment,” comprising two steps: (i) analyzing biomarker expression in a tissue sample, and (ii) classifying the patient as responsive or not responsive based on their biomarker expression. In contrast, Genentech’s US patent claims “[a] method for treating or delaying progression of cancer,” comprising the same two steps as the European patent, along with a third step: administration of an OX40 agonist. Again, this limitation substantially weakens the US patent and leaves Genentech’s biomarker innovation vulnerable to copying.
The USPTO’s requirement that diagnostic methods recite an additional treatment step represents a significant barrier to investment in diagnostic innovation. Genentech, for example, did not invest in biomarker research for the sake of its patentability. At the time these patents were prosecuted, Genentech had a promising OX40 agonist in the early stages of clinical trials for locally advanced or metastatic solid tumors. It needed to better define the patient population that would respond to its treatment. Genentech was therefore independently incentivized to invest in diagnostic biomarker research, regardless of whether the fruits of such research would be patentable themselves. This was the backdrop for the Chugai patents as well: Chugai was developing an IL-6 inhibitor for the treatment of multiple sclerosis, and invested in diagnostic research in order to better define its patient population. Under the USPTO’s current framework, innovations in diagnostic methods are only valuable to the extent they can bolster the profitability of an existing drug, device, or method of treatment. The Chugai and Genentech patents illustrate this reality.
B. The Limits of Vanda-type Drafting, and Impacts on the Diagnostic Market
Vanda-type claim drafting may confer some level of patentability for diagnostic methods in the US, but it falls short of protecting the diagnostic method itself. Framing methods of diagnosis as methods of treatment substantially limits their scope and applicability. It is also not a viable approach for applicants whose diagnostic method cannot be drafted to involve a treatment or administration step. For instance, “a method of determining the likelihood of early-onset Alzheimer’s disease” would likely be unpatentable under Mayo, assuming there is no preventative drug or treatment to append to the claim. Similarly, “a biomarker-based method of diagnosing an individual with a high risk of deep vein thrombosis” (a condition that often lies dormant, undiscovered until the individual has a life-threatening pulmonary embolism) would not be patent-eligible unless it could be drafted to involve a step of administering preventative treatment. Both of these methods would be of enormous benefit to the public, but the USPTO’s current patentability regime fails to adequately incentivize their development. The result, as the next case studies will show, is under-investment in innovation in the diagnostics market.
1. The Laboklin Patents
The Laboklin patents provide an example of a diagnostic method patent that could not be saved by strategic drafting, and the market dynamics that ensue. Researchers at the University of Bern discovered a way to identify Labrador Retrievers that are healthy carriers of a genetic disease called hereditary nasal parakeratosis. The University obtained patents in the US and Europe, and licensed those patents to a veterinary laboratory company, Laboklin, that specializes in genetic testing services for animals. The European patent claims “[a]n in vitro method of determining the genotype relating to hereditary nasal parakeratosis (HNPK) in a dog,” while the US patent claims “[a]n in vitro method for genotyping a Laborador Retriever.” In general, the US patent claims seem to avoid all mention of the disease itself, probably as an attempt to avoid a Mayo-based rejection. Nevertheless, in Genetic Veterinary Sciences v. Laboklin, 933 F.3d 1302 (Fed. Cir. 2019), the Federal Circuit held that the claims were patent-ineligible under Mayo. The court reasoned that the claims were directed to the natural phenomenon of a genetic mutation in dogs, and did not recite an inventive concept sufficient totransformthis phenomenon into a patentable invention. Laboklin’s European patent remains valid and in full force under the EPO patentability framework.
An analysis of the veterinary genetic testing market reveals the effects of the Federal Circuit’s decision in Laboklin. The immediate outcome in the US has been the ability of multiple companies to compete with Laboklin in offering the HNPK test for Laborador Retrievers. At least three companies currently offer the test as an individual service, while additional companies offer it bundled with other tests. Prices for the individual service in the US range from $45 to $80. In the United Kingdom, where the European patent remains in force, Laboklin offers the test for £84 ($112). This price markup is a function of the European patent rather than other factors, as Laboklin offers a non-patented HNPK test for greyhounds for only £54 ($72). The price disparity between the US and the UK indicates that the Laboklin decision has resulted in more competition and cheaper prices for the HNPK Laborador test in the US.
The tradeoff, however, is the risk of blunting incentives for innovation in genetic testing methods. Lost incentives are more difficult to measure, but an examination of Laboklin’s current patent portfolio is one way to assess how Laboklin might approach investments in US patents. Laboklin is the licensee of 8 global families of veterinary genetic testing patents. Only two of these patent families include US patents: one related to a method of detecting canine exercise-induced collapse, and another related to a method of detecting equine polysaccharide storage myopathy. Revealingly, Laboklin let the first US patent expire prior to the end of its term. As for the second US patent (the one claiming the equine genetic test), Laboklin never bought the license to it at all. Laboklin seems to have bought the rights to prosecute the patent for the equine test in Europe, but the original US patent was licensed instead to the University of Minnesota (presumably because Laboklin was not interested in buying it). Laboklin is just a single company in the veterinary genetic testing market, but its patent portfolio and strategic behavior suggest low enthusiasm for investments in US diagnostic patents.
2. The Sequenom Patents
The Sequenom patents provide another example of an invention that could not be made patentable by Vanda-type drafting. Sequenom’s patents for noninvasive prenatal diagnosis claim a method of performing prenatal diagnosis based on the analysis of cell-free fetal DNA in a maternal blood sample. This family of patents arose from research at Oxford University by Dennis Lo, who discovered a method of detecting fetal DNA in the plasma of a pregnant woman by using the male chromosome as a marker. This discovery essentially created the field of noninvasive prenatal testing (NIPT), enabling early detection of genetic abnormalities, more reproductive autonomy, and better monitoring of pregnancy. A global market soon developed around NIPT. Most of the relevant patents were held by universities and nonprofit research institutions, who executed exclusive licensing agreements with laboratory testing companies for commercial marketing.
The Lo patents were licensed exclusively to Sequenom for global marketing. As competitors of Sequenom entered the market, intense legal battles over the diagnostic technologies unfolded worldwide. In 2015, Sequenom’s US patent was invalidated by the Federal Circuit in Ariosa as directed to a natural phenomenon and therefore unpatentable. The European patent, whose representative claims are substantially the same as the US patent, was also challenged in opposition proceedings at the EPO. The challenge there was based not on grounds of subject-matter eligibility, but instead on grounds of lack of an inventive step and insufficiency of disclosure. The EPO Board of Appeals upheld the Sequenom patent, and it remains in full force in Europe.
The case of the Sequenom patents stands as a warning to prospective investors in diagnostic innovations, and this is regrettable. Patents were key in driving the rapid development of NIPT technology and its widespread clinical availability. They facilitated massive technology transfer between the public and private sectors, and also between entities within the private sector. Sequenom, for example, executed a cross-licensing agreement with Illumina in 2014 to form a patent pool for licensing of NIPT technologies to third-party laboratories across the world. In short, the clinical translation of NIPT technologies was largely driven by industry. Industry is responsive to the perceived risk of investments in intellectual property. The invalidation of Sequenom’s US patent broadcasted the weakness of diagnostic method patents under the Mayo framework, thereby chilling incentives for innovation and investment in new diagnostic technologies. The evident weakness of stand-alone diagnostic method patents after Mayo and Ariosa tips the scales away from industry investment in the field, to the detriment of new diagnostic industries and ultimately, public health.
III. Recommendations for Change
As discussed in Part I, the patentability regime for diagnostic methods differs greatly between Europe, the US, and Japan. Diagnostic methods are generally patentable in Europe, as long as they are not practiced directly on the human body. In Japan, diagnostic methods are not patentable, strictly speaking, but it is fairly straightforward to claim them as methods of prediction or detection, which are patentable. In the US, diagnostic methods are not patentable unless they either recite a treatment step or involve unconventional or nonroutine techniques.
Of the three regimes, the US offers the weakest patent protection for methods of diagnosis. The case studies analyzed in Part II demonstrate the limitations of Vanda workarounds. They also reveal the troubling implications of the Mayo framework for innovation in the diagnostic marketplace. The US must find a way to better protect methods of diagnosis and thus restore the incentives for innovation in this field.
Reform could be accomplished in one of two ways. First, Congress could amend 35 U.S.C.§ 101, as has recently been proposed in Congress, to forgo the judicially-created exceptions to eligibility and make all “useful” methods in any field of technology patent-eligible subject matter. Amending § 101 would bring clarity to the patentability question for diagnostics, but would also disrupt a half-century of caselaw for all fields of innovation, creating uncertainty for patent applicants, the USPTO, and investors. Alternatively, the Supreme Court could overrule Mayo and either (1) restrict Mayo’s broad conception of “laws of nature” so that the exception does not encompass responses of the human body to conditions that arise from human intevention; or (2) declare methods of diagnosis to be practical and useful applications of natural relationships (as methods of treatment are). Under option (2), the Supreme Court could even decide to keep the Mayo inquiry intact, and overrule Mayo’s holdingonly with respect to its facts. This course of action would be minimally disruptive to the caselaw, to USPTO examination procedures, and to other fields of innovation.
Strengthening patent protection for diagnostic methods would promote investment in commercialization of diagnostic technologies. It would also support international alignment of patent standards, streamlining technology transfer and investment on a global scale. However, strengthened diagnostic patents give rise to two concerns that are worth addressing. The first is that stronger patent protection for diagnostic methods is not necessary for diagnostic innovation. After all, devices, kits, and methods of treatment are all patent-eligible subject matter under the current conception of Mayo. And the field of diagnostics already benefits from huge public sector investments in diagnostic research. Perhaps conferring stronger patent protection on methods of diagnosis would be redundant, or would only serve to tie up diagnostic discoveries that should remain in the public domain.
In considering this possibility, we must grapple with the difficulty of measuring the value of lost innovation potential. The US is a dominant force in the global biomedical market, and as a result we cannot look to another system where diagnostic methods are patentable to compare the respective levels of innovation. Simply put, we have no counterfactual with which to compare. However, some have argued that the COVID-19 pandemic has exposed widespread underinvestment in clinical diagnostics. Moreover, it takes an estimated $50-$100 million to commercialize a diagnostic test. And while public sector investments in basic science research are important, they do not make patent protection redundant. As shown by the NIPT case study, patents drive commercialization of diagnostic technologies, which is essential for the translation of discoveries to patient care. Given high upfront costs, a complex regulatory scheme, and frequent reimbursement challenges, it is important that those who invest in commercialization of diagnostic technologies can realize gains from their investments. A more robust patentability regime for diagnostic methods is therefore critical for investment and innovation in the field.
A second concern with strengthening diagnostic patents is the possible creation of diagnostic monopolies, which raise concerns about patient access and test quality.
In a diagnostic monopoly, a single firm serves as the sole provider of a given diagnostic test. If that sole provider does not have contracts with certain health insurers allowing for reimbursement, patients with those health insurance plans may lack access to the test. Moreover, in the absence of competition, test quality could conceivably fall below an optimal standard of care. However, a study prepared for a task force of the Secretary’s Advisory Committee on Genetics, Health and Society did not find evidence that patents restrict access or quality of genetic diagnostic tests. It acknowledged that these issues may arise in the context of exclusive licensing of diagnostic patents, but the patents themselves are not problematic in this regard.
To address the problem of diagnostic monopolies, Congress could regulate or limit the exclusive licensing of diagnostic patents. It could also establish a centralized licensing body to allow the government to negotiate licenses of diagnostic patents for use by public institutions. However, diagnostics is a complex field with many different stakeholders, and the intricacies of its regulation are outside the scope of this paper. They are also outside the scope of US patent policy. In the US, the patent system is an incentive-based system concerned with “the progress of science and useful arts.” Its central focus is innovation. Regrettably, the current conception of the Mayo framework undercuts diagnostic innovation and holds back advancement in precision medicine. The US must reform its patentability framework, and soon: the future of precision medicine hangs in the balance.
Method for predicting post-therapy prognosis of relapsing-remitting multiple sclerosis (RRMS) patient, and method for determining applicability of novel therapy
Assignee: Chugai Pharmaceutical Co. Ltd.; National Center of Neurology and Psychiatry (JP)
Patent Status: Granted in the US, Europe, and Japan.
US Patent No. 10,782,290 June 11, 2014
A method for determining the therapeutic effect of an IL-6 inhibitor on a relapsing-remitting multiple sclerosis patient and treating the patient, the method comprising the steps of:
(i) obtaining a biological sample from the patient with relapsing-remitting multiple sclerosis, wherein the biological sample comprises a whole blood or peripheral blood sample;
(ii) measuring the amount of a plasmablast contained in the biological sample isolated from the relapsing-remitting multiple sclerosis patient; (iii) determining that the therapeutic effect of the IL-6 inhibitor is high when the amount of the plasmablast measured in the patient is high as compared with a healthy individual; and (iv) administering an amount of the IL-6 inhibitor to the patient effective to treat the relapsing-remitting multiple sclerosis in the patient exhibiting a high amount of plasmablast.
EPO Publication No. EP3009518A1 June 11, 2014
A method for predicting the therapeutic effect of an IL-6 inhibitor on a relapsing-remitting multiple sclerosis patient, the method comprising the steps of:
(iii) measuring an amount of a plasmablast contained in a biological sample isolated from the relapsing-remitting multiple sclerosis patient; and
(iv) showing that the therapeutic effect of the IL-6 inhibitor is high when the amount of a plasmablast is high as compared with a healthy individual.
JPO Publication No. JP6442404B2 June 11, 2014
A method for predicting the therapeutic effect of an IL-6 inhibitor in patients with relapsing-remitting multiple sclerosis,
(v) measuring the amount of plasma blast contained in a biological sample isolated from a patient with relapsing remitting multiple sclerosis; and
(vi) a method comprising a step of showing that a therapeutic effect by an IL-6 inhibitor is high when the number of plasma blastcells is high or the ratio thereof is high compared to healthy individuals.
Methods and biomarkers for predicting efficacy and evaluation of an OX40 agonist treatment
Assignee: Genentech, Inc.
Patent Status: Granted in the US and Europe [pending in Japan].
US Patent No. 10,767,232 Dec. 8, 2017
A method for treating or delaying progression of cancer in a subject, comprising:
(a) measuring the expression level of one or more marker genes in a sample comprising leukocytes obtained from the subject, wherein said one or more marker genes are selected from the group consisting of CD8a, CD8b, H2-d, CTLA4, CD64, CXCL9, IFNg, IDO1, GZMA, GZMB, PRF1, PDCA1, KLRK1, PTPRC, CXCL1, ITGAM, and IL7R; and
(b) if the expression level of said one or more marker genes in the sample obtained from the subject is higher than a reference, administering to the subject an effective amount of an OX40 agonist….
EPO Publication No. EP3215637B1 Nov. 2, 2015
A method for predicting responsiveness of a subject having cancer to an OX40 agonist treatment, comprising:
(a) measuring the expression level of one or more marker genes in a sample comprising leukocytes obtained from the subject, wherein said one or more marker genes are selected from the group consisting of CD8a, CD8b, H2-d, CTLA4, CD64, CXCL9, IFNg, IDO1, GZMA, GZMB, PRF1, PDCA1, KLRK1, PTPRC, CXCL1, ITGAM, and IL7R; and
(b) classifying the subject as a responsive or non-responsive subject based on the expression level of said one or more marker genes in the sample obtained from the subject, as compared with a reference, wherein an increased expression level of the one or more marker genes as compared with the reference indicates the subject may be responsive to an OX40 agonist treatment.
Method of determining the genotype relating to hereditary nasal parakeratosis (HNPK) and nucleic acids usable in said method
Assignee: Bern Universitaet
Patent Status: Granted in Europe and US.
Struck in Genetic Veterinary Scis., Inc. v. LABOKLIN GmbH & Co. KG, 933 F.3d 1302 (Fed. Cir. 2019) as unpatentable under Mayo.
US Patent No. 9,157,114 May 21, 2013
An in vitro method for genotyping a Labrador Retriever comprising: a) obtaining a biological sample from the Labrador Retriever; b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.
EPO Publication No. EP2666871B1 May 15, 2013
Anin vitromethod of determining the genotype relating to hereditary nasal parakeratosis (HNPK) in a dog comprising determining the presence or the absence of a genetic variation in the SUV39H2 gene sequence in a biological sample from said dog, wherein the presence of said genetic variation indicates that said dog suffers or will suffer from said disorder or is at risk of transmitting said disorder to its progeny,….
Assignee: Sequenom Inc.
Patent Status: Granted in the US, Europe, and Japan.
Invalidated in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) as unpatentable under Mayo.
Upheld by EPO in Case T-0146/07 (Prenatal diagnosis/ISIS) of Dec. 13, 2011 against inventive step and sufficiency of disclosure challenges.
US Patent No. 6,258,540 Nov. 29, 1999
A method of performing a prenatal diagnosis, which method comprises the steps of:
(i) providing a maternal blood sample;
(ii) separating the sample into a cellular and a non-cellular fraction;
(iii) detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction according to the method of claim 1;
(iv) providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid.
EPO Publication No. EP0994963B1 Mar. 4, 1998
A method of performing a prenatal diagnosis, which method comprises:
(i) separating a maternal blood sample into a cellular and non-cellular fraction;
(ii) detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction using the method of any one of claims 1 to 19; and
(iii) providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid.
JPO Publication No. JP4705774B2 Oct. 15, 2004
A method for performing non-invasive detection of fetal genetic traits comprising: subjecting extracellular DNA from a plasma or serum sample of a pregnant woman to size separation comprising DNA of 500 and fewer base pairs; and obtaining a fraction of extracellular DNA and further determining the fetal genetic trait to be detected by subjecting said fraction to PCR (polymerase chain reaction) technology, ligase chain reaction or probe hybridization technology, or nucleic acid array.
Genentech HER2 Patents
Gene detection assay for improving the likelihood of an effective response to a HER2 antibody cancer therapy
Assignee: Genentech, Inc.
Patent Status: Granted in the US and Japan.
European patent revoked in EPO opposition procedures; see Case T-2524/12 (Anti-ERBB antibody cancer therapy/GENENTECH) of Nov. 7, 2016.
US Patent No. 8,440,402 Dec. 11, 2011
A method for identifying and treating a patient disposed to respond favorably to a HER2 antibody, huMAb4D5-8, for treating breast cancer, which method comprises detecting her2 gene amplification in tumor cells in a tissue sample from the patient and treating the patient with her2 gene amplification with the HER2 antibody in an amount effective to treat the breast cancer, wherein the patient's tumor cells express HER2 at a 0 or 1+ level by immunohistochemistry.
JPO Publication No. JP6513355B2 Sept. 8, 2014
Use of an anti-HER2 antibody in the manufacture of a medicament for treating cancer in a subject, comprising: The tumor cells of interest are determined to have a HER2 expression level of 0 or 1+ by immunohistological staining on formaldehyde fixed tissue samples,
wherein the subject is determined to be one who has amplified the HER2 gene in tumor cells in a tissue sample obtained from the subject.
Barbara S. Craft et al., Adjuvant Biologic Therapy for Breast Cancer, 13 The Cancer Journal 156 (2007).
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments, U.S. Food & Drug Admin. (Apr. 22, 2020), https://www.fda.gov/news-events/press-
Lida A. Mina et al., Immunotherapy for the Treatment of Breast Cancer: Emerging New Data, 11 Breast Cancer 321 (2019).
Hannah Mamuszka, Mission Possible: Moving Diagnostics to the Forefront of Precision Medicine, J. Precision Medicine (2017), https://www.thejournalofprecisionmedicine.com/wp-content/up loads/2015/10/Mamuszka.pdf
EPC Art. 52(1).
Guidelines for Examination Part G, Ch. I, subpt. 3, European Patent Office, https://www.epo.org/law-practice/legal-texts/html/guidelines/
While methods of treatment are not patentable in Europe, a substance or composition may be patented for a use in treatment or diagnosis. See EPC Art. 54(5).
EPC Art. 53(c). EPO Decision T666/05; Decision T775/92 (remote interaction with the body counts as a patent-eligible diagnostic method). In cases where the diagnosis must be performed directly on the human body, inventors may still patent the device or instrument used for diagnosis.
See Guidelines for Examination Part G, Ch. II, subpt. 5.3, European Patent Office, https://www.epo.org/law-practice/legal-
texts/html/guidelines/e/g_ii_5_3.htm;E.U. Dir. 98/44/EC, rec. 42.
EPO Decision T-1255/06 (Radiation detector for tymphanic temperature measurement) of Sept. 23, 2008.
Even methods of diagnosis that do not require the participation of a medical practitioner may be considered diagnostic in character, and thus patent-eligible. EPO Decision G-0001/04 (Diagnostic methods) of Dec. 16, 2005.
Mayo Collaborative Services v. Prometheus Labs, 566 U.S. 66 (2012),
Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014).
Id.at2355 (quoting Mayo, 566 U.S. at 75-79).
Mayo, 566 U.S. at 74-75.
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).
Id. at 1376, 1378.
Id. at 1376.
See, e.g. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1285 (Fed. Cir. 2015) (Lourie, J., concurring in the denial of rehearing en banc) (“It is… said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.”).
Mateo Aboy et al., Mayo’s Impact on Patent Applications Related to Biotechnology, Diagnostics and Personalized Medicine, 37 Nature Biotech. 502 (2019).
Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018),cert. denied, 140 S. Ct. 911 (Jan. 13, 2020).
Id. at 1135.
Id. at 1134-35.
Id. at 1136.
See Brief of the United States as Amicus Curiae, Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc., 140 S. Ct. 911 (Jan. 13, 2020), https://www.supremecourt.gov/DocketPDF/
20-%20CVSG%20-%20v28.pdf. [hereinafter Vanda Amicus Brief].
Id. at 8.
Id. at 10.
Id. at 14.
Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).
See Cleveland Clinic Found. v. True Health Diagnostics, 859 F.3d 1352 (Fed. Cir. 2017)(where patent claimed a method of testing for risk of cardiovascular disease by measuring blood levels of an enzyme, patent was directed to a natural law and did not involve a practical application of that law, and so were ineligible under Mayo); Endo Pharms. v. Teva Pharms. USA, 919 F.3d 1347 (Fed. Cir. 2019) (finding method of treatment claims eligible under Vanda, where claims were directed to a method of pain management in patients with renal impairment, because they included an administration step), Natural Alternatives Intl. v. Creative Compounds, 918 F.3d 1338 (Fed. Cir. 2019) (finding method of treatment claims patent eligible where method related to the use of natural compounds to increase anaerobic capacity, because they involved a step of administering unnaturally high levels of beta-alanine, and as as result were not directed to a natural law); see also MPEP § 2106.04.
Athena, 915 F.3d at 763 (Newman, J., dissenting).
Examination Guidelines for Patent and Utility Model in Japan (Provisional Translation) at 3.1.1, Japan Patent Office, https://www.jpo.go.jp/e/system/laws/rule/guideline/patent/
tukujitu_kijun/document/index/all_e.pdf[hereinafter,JPO Examination Guidelines].
Id. at 3.1.1(3)(i)-(ii)
Id. at 3.1.1(2).
Id. at 3.2.1(1).
Id. at 3.2.1(2).
Id. at 3.2.1(3). A method of treatment of extracted samples is patentable so long as they will not be returned to the human body. Id. at 3.2.1(4).
Id. at Ex. 5 (paraphrased).
Id. at Ex. 4 (paraphrased).
Nobutaka Yokota, Patent Eligibility Expanded, ManagingIP(Sept. 30, 2009), https://www.managingip.com/article/b1kcg8rsz47fjg/
Id.This could also be drafted as a Swiss-type claim.
A recent study involving a cohort of 16 patents suggests that after Vanda, many diagnostic method claims that receive Mayo-based rejections are being amended to method of treatment claims in the course of patent prosecution.See Mateo Aboy et al., One Year After Vanda, Are Diagnostics Patents Transforming into Methods of Treatment to Overcome Mayo-Based Rejections?, 38 Nature Biotech. 279-83 (Mar. 2020).
See Appendix at 47-48.
The question of liability for divided infringement in this hypothetical is worth discussion. To be liable for induced infringement of a method patent under 35 U.S.C. § 271, a party must either “direct or control” the other’s performance of the method steps, or the two actors must form a “joint enterprise.”See Travel Sentry, Inc. v. Tropp, 497 F. App’x 958, 965 (Fed. Cir. 2012); Akamai Fechs. Co. v. Limelight Networks, Inc., 692 F.3d 1301 (Fed. Cir. 2012) (en banc). In the plasmablast test hypothetical, the manufacturers of the diagnostic test would either have to “direct or control” the actions of the treating physicians, or form a “joint enterprise” with them.
A similar fact pattern to this hypothetical arose inCleveland Clinic (see supra note 31), in which the owners of a diagnostic method patent asserted a claim for induced infringement against the makers of a diagnostic test. The district court dismissed the claim on the grounds that the plaintiff failed to plausibly allege that the test manufacturer specifically intended to induce doctors to administer a lipid lowering agent based on the results of the test.Cleveland Clinic Found. v. True Health Diagnostics, LLC, No. 1:15 CV 2331, 2016 U.S. Dist. LEXIS 21907, at *26-27 (N.D. Ohio Feb. 23, 2016). The complaint also lacked factual allegations regarding the relationship between the test manufacturer and doctors who ordered the test. Id. This case underlines the weakness of diagnostic method patents that include a treatment step, and suggests that the maker of a plasmablast test in the U.S. would likely be free from infringement liability.
See JPO Examination Guidelines, supra note 33, at 3.1.1(3).
See Appendix at 48.
Ken Garber, Immune Agonist Antibodies Face Critical Test, Nature Rev. Drug Discovery News (Dec. 11, 2019).
Chugai Presents Results from Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019, Chugai Pharmaceutical Co. News (Sept. 12, 2019), https://www.chugai-
See Appendix at 48-49.
Genetic Veterinary Scis., Inc. v. LABOKLIN GmbH & Co. KG, 933 F.3d 1302 (Fed. Cir. 2019).
The price for a single test is $45 at animalgenetics.us; $55 at www.vetgen.com, and $80 at pawprintgenetics.com.
Order Form, Laboklin: Laboratory for Clinical Diagnostics, https://www.laboklin.co.uk/pdf/GeneticTests-DogsCats-B-Form.pdf.
Catalogue 2020-21, Laboklin: Laboratory for Clinical Diagnostics (2020), https://laboklin.com/fileadmin/FILES/Downloads/Preise_
US Patent No. 8,178,297.
US Patent No. 8,268,557; EP 2121969B1; Equine PSSM Genetics, LLC v. Animal Genetics, Inc., No. 14-493 (MJD/FLN), 2015 U.S. Dist. LEXIS 23967, at *1 (D. Minn. Feb. 10, 2015).
See Appendix at 49-50.
Robert Cook-Deegan & Subhashini Chandrasekharan, Sequenom v. Ariosa— The Death of a Genetic Testing Patent, 375 New Eng. J. Med. 2418 (2016).
Ashwin Agarwai et al., Commercial Landscape of Noninvasive Prenatal Testing in the United States, 33 Prenatal Diagnosis 521 (2013).
Cook-Deegan & Chandrasekharan, supra note 60.
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).
EPO Decision T-0146/07 (Prenatal diagnosis/ISIS) of Dec. 13, 2011.
Cook-Deegan & Chandrasekharan, supra note 60.
Illumina, Sequenom Pool NIPT Patents, Settling IP Disputes, GenomeWeb (Dec. 3, 2014), https://www.genomeweb.com/business
Agarwai et al.,supranote 61 (stating that “the clinical translation of NIPT technologies has been predominantly spearheaded by industry.”).
Johnathon Liddicoat et al., The Effects of Myriad and Mayo on Molecular-Test Development in the United States and Europe: Interviews from the Frontline, 22 Vand. J. Ent. & Tech. L785 (2019).
See Draft Bill to Reform Section 101 of the Patent Act, https://www.tillis.senate.gov/services/files/E8ED2188-DC15-4876-
See Vanda Amicus Brief, supra note 25, at 14 (arguing that Mayo greatly expanded the conception of “law of nature” under § 101 and therefore warrants reconsideration).
Timo Minssen & Robert Schwartz, Separating Sheep from Goats: A European View on the Patent Eligibility of Biomedical Diagnostic Methods, 3J. Law & Biosciences 365, 370 (2016) (arguing that lack of uniformity may violate treaties to which the US is currently a party).
See Rebecca S. Eisenberg, Diagnostics Need Not Apply, 21 B.U. J.Sci. & Tech. L.256, 284 (2015) (“Biomedical research in general, and genomics research in particular, have benefited from significant government subsidies that provide direct support for research that has facilitated the development of diagnostic tests.”).
The COVID-19 Testing Debacle, 38 Nature Biotech.653 (2020) (arguing that “reimbursement cuts by the 2014 Protecting Access to Medicare Act, erosion of intellectual property protection, and a lack of regulatory clarity has depressed profit margins and stunted investment”).
Athena Diagnostics v. Mayo Collaborative Servs., 927 F.3d 1333, 1335 (Fed. Cir. 2019) (J. Moore, dissenting).
The losers of the current regime may actually be universities and research institutions, who otherwise would be free to engage in more licensing of the diagnostic methods they discover and patent.
See The COVID-19 Testing Debacle, supra note 73; Nafees N. Malik, Overhauling the Reimbursement System for Molecular Diagnostics, 29 Nature Biotech. 390 (2011); Joshua P. Cohen & Abigail E. Felix, Personalized Medicine’s Bottleneck: Diagnostic Test Evidence and Reimbursement, 4J. Personalized Medicine 163 (2014) (study of drug-diagnostic combinations finding that reimbursement of companion diagnostics was limited and highly variable).
Agarwai et al., supra note 61.
Robert Cook-Deegan et al., The Dangers of Diagnostic Monopolies, 458 Nature 405 (2009).
See Johnathon Liddicoat et al.. Continental Drift? Do European Clinical Genetic Testing Laboratories Have a Patent Problem?, 27 Eur. J. Human Genetics 997, 1005 (2019). Indeed, if the diagnostic patents contain government-interest statements, then the government already has the right to dictate the terms of their licensing and use pursuant to the Bayh-Dole Act, 35 USC 202(c)(6).
U.S. Constitution, Art. I § 8 cl. 8.
Hon. William C. Conner Writing Competition first place Winner
Global Diagnosis: The Future of Diagnostic Method Patents in Precision Medicine
By: Charlotte Geaghan-Breiner
Columbia Law School, Class of 2021
GLOBAL DIAGNOSIS: APPENDIX
MINUTES OF MARCH 9, 2021
MEETING OF THE BOARD OF DIRECTORS OF THE
NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION
The Board meeting was held via videoconference. President Colman Ragan called the meeting to order at approximately 4:00 p.m. In attendance were:
Colman Ragan, President, presiding
Alicia Russo (joined at 4:15 p.m.)
Abigail Struthers (left at 5:00 p.m.)
Feikje van Rein attended from the Association’s executive office. John Mancini was unable to attend. The meeting was called to order by President Colman Ragan. Minutes from prior meeting were approved.
Financial Report: The monthly numbers do not yet reflect sponsorships and ticket sales, so next month’s figures will look higher. The organization, like many others, has been impacted by the pandemic but we are in a better place than we thought we would be at this time.
New members were approved and admitted. The Board discussed the fact that all the new members were law students. This was attributed to the Connor Writing Competition and scholarship foundation outreach to law schools.
Judges' Dinner: Recipes have been submitted, though more submissions are welcome. Swag bags are nearly all been taken so the Board discussed options for adding more. The Board also discussed the Remo platform’s difficulty with strong email filters.
Amicus Briefs Committee: ABC is monitoring cases, including where briefs have been filed, like in Arthrex, as well as upcoming cases like the Pocky design patent case for confectionary goods. The ABC asked the Board to approve a proposed amicus filing in Samsung v. Ericsson, which deals with multiple jurisdictions claiming to have ability to set global FRAND rate between parties. The proposed brief takes the position of cautioning the US courts not to allow China to set global FRAND rates because China sets notoriously low rates at a disadvantage to US businesses.
Because enough Board members were conflicted out, a motion was made to permit the Board to proceed with deciding whether to approve the filing of a brief, despite not reaching a quorum, because it is a matter important enough that the organization should weigh in. The Board members approved the motion and then a second motion to approve the position was passed.
Legislative Action Committee: Colman reported that the focus has been the stimulus bill and the economy so not much else is being brought to the floor for a vote again. Kathleen is in touch with Chris Israel regarding sending someone from NYIPLA to a hearing for the Shop Safe act. She discussed the criteria which sounded like the government was more interested in hearing from someone who can speak to the consumer health and safety perspective.
Nominating Committee: Kathleen reported there will be another call to get the members together. There have been a few nominations already. Still accepting nominations until the end of the week. Kathleen noted that she and Feikje discussed potentially having a junior board member position created. The Board discussed the fact that it would require a change to the bylaws which was unlikely to be feasible this year. A motion was made to create a subcommittee to explore the idea of creating a junior board. The Board members discussed the value of supporting young attorneys who are aspiring leaders and approved the motion.
IOTY Update: Paul reported that the extended deadline helped generate 2 great candidates for the award. The deadline is on Friday so there may be a few stragglers but there are enough to proceed.
Connor Writing Competition Update: Similar to IOTY, Gene reported that the extension and email marketing reminder generated enough submissions to proceed with the competition and run it again next year.
02.17 Young Lawyers Virtual Poetry Slam was well-attended and participation was great. Rob noted that it would be well-suited to be an annual event.
0.2.25 Getting Ready for Arthrex Oral Arguments Charles Macedo put together a great presentation. The event was advertised through email blasts, LinkedIn, and invitations to committee members. The presentation was well-received.
03.10 Biologics & Biosimilars John reported that the event had 34 registered as of the board meeting. The Board members discussed how the event typically generates over 60 registered attendees and noted that the amount generated was good considering it is a year into the pandemic.
03.24 Celebrating the Legacy of Justice Ginsburg The Women in IP committee co-chairs, Linnea and Alexandra proposed the event idea as a way to increase engagement and membership in the committee. There are a panel of former clerks who will speak to their experience working with Justice Ginsburg.
The meeting was adjourned at approximately 6:00 p.m.
The Board meeting was held via videoconference. President Colman Ragan called the meeting to order at approximately 4:00 p.m. In attendance were:
Colman Ragan, President, presiding
Heather Schneider (joined at 4:45 p.m.)
Feikje van Rein attended from the Association’s executive office. Meeting started with quorum of 9 present. Abigail Langsam and Marc Pensabene were unable to attend.
The meeting was called to order by President Colman Ragan with a quorum of 9 present. Minutes from prior meeting were approved.
Ksenia from the Inventor of the Year Committee presented the committee’s nominations. The Board discussed and approved the two nominees, Dr. Yancopoulos, who worked on a multi-antibody cocktail approach and Dr. Kyratsous, who worked on the development of therapeutics for infectious disease.
Feikje provided a summary of the financial report. Financial standings are the same but adjustments for deposits have been moved to next year and will now show up as pre-paid expenses. Revenue is coming in from Judge’s Dinner from sponsorships and individual registrations. $96,500 currently and total revenue expected is $171k. Overall the organization is at a loss but not as large as auditors were concerned about. Total expenses are about $75k and right now, only $17k listed. Revenue on Judge’s Dinner is about $100k. New members have been deferred until next year after the Judge’s dinner.
Amicus Briefs Committee: Rob Isackson reported that there is not much activity going on right now. The committee most recently filed a brief in Ericsson, which was approved without a full quorum of the board. A few cases that were being monitored were dropped.
Colman Ragan proposed putting out statements on behalf of the NYIPLA, one supporting diversity and the Asian American community, and another to extend condolences for Judge Florenstein of the Eastern District. The board members approved both statements and volunteers formed project groups to help draft statements to circulate for the board to review.
Legislative Action Committee: Colman reported that Chris Israel is reviewing the proposed statement on patent anti-trust bills to make it “placeable” and the plan is to issue as a press release or through Law360. The board discussed various mechanisms for issuing press releases and the desired audience(s). Kathleen reported that the Copyright & Trademark committee are working together on a half-day CLE. The Copyright Committee is also considering a presentation to cover Google v. Oracle.
Nominating Committee: Kathleen reported that Patrice will be Second VP replacing Jenny Lee. Diana Santos will stay on the board. Abby is stepping away from position as treasurer but will remain on the board. Scott Greenberg will step in as treasurer and David Goldberg will fill the empty spot on the board. Alicia Russo, John Moehringer, and Jonathan Alba are on the programs committee.
IOTY Committee Status: Rob Isackson brought this for the board to discuss whether to keep this award and/or discuss ideas to revamp the award such as by broadening the scope of potential awardees. The board members discussed ways to improve the nomination process while maintaining a process that is properly unbiased in both spirit and letter. The members discussed the fact that this year the nominations were timely and noteworthy. As a result, the board decided to table the discussion.
Connor Writing Competition: Gene reported that there was a total of 29 entries which doubles last year’s entries. The entries were reduced to 8 which will be vetted in the 2nd round. Topics covered a broad range including AI & inventorship, work-for-hire as applied to comic book creators, diagnostic method patents.
Young Advisory Board: Diana reported that a small committee group set up an Associate Advisory Council. The proposal is that the eligibility be set at mid-senior level associates between 5-12th year of practice. Parameters of the role include supporting organization’s objectives, increasing network, growing newer committee groups and fostering young lawyers and law students. The proposed term is 2 years with a maximum of 2 terms. Proposed candidates were provided to the board members with Linkedin pages for review. The board members discussed and motions to approve the proposed structure and the 3 candidates were approved.
Previous/Upcoming programs: March 24th women’s committee event Celebrating the Legacy of Justice Ginsburg was well-received and attended with 20-25 people registered. Marc was not available to speak to the May 5th event on Creating Value from IP Assets: Legal Finance Perspectives. Patrice reported that the May 12th NYIPLEF Virtual Bingo Night is a test fundraising event that is launching before the annual dinner on May 18th. The full marketing will launch after the Judge’s Dinner event.
The board members then proceeded to the Remo platform to test out the Judge’s Dinner portal at around 5:11 p.m.
MINUTES OF APRIL 13, 2021
MEETING OF THE BOARD OF DIRECTORS OF THE
NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION
MINUTES OF MAY 18, 2021
MEETING OF THE BOARD OF DIRECTORS OF THE
NEW YORK INTELLECTUAL PROPERTY LAW ASSOCIATION
The Board meeting was held via videoconference. President Colman Ragan called the meeting to order at approximately 5:30 p.m. In attendance were:
Rob Isackson, President, presiding
Feikje van Rein attended from the Association’s executive office. Eric Greenwald and Christine Lauture attended as Associate Advisory Council members. Marc Pensabene, Paul Bondor, John Mancini and Khalil Nobles (AAC) were unable to attend.
The meeting was called to order by President Rob Isackson, who welcomed the new Board Members and Associate Advisory Council Members. Minutes from prior meeting were approved subject to an edit of the attendance list to include Rob Rando.
The President discussed the board book and the importance of signing the Annual Disclosure Statement.
Financial Report. Abigail Struthers is retiring from the position but will remain on the board. Scott Greenberg will provide the Financial Report starting with the next meeting. The organization lost less than last year. The organization is still in the black and made some money on the most recent Judge’s Dinner. There are still some deposits from the cancelled 2020 dinner, such as the Hilton, that have rolled over.
New Members. There were 7 new members, which included a mix of law firm associates, law students and in-house counsel. Motions to admit and waive reading of the names were approved.
Amicus Briefs Committee. Rob Isackson reported that the committee met but there are no new actions. The committee is watching 12-14 cases, covering a variety of subject matter. Of the monitored cases, 3 involve trademark, 1 involves copyright, 1 involves patent anti-trust and 1 is a contract case. Rob explained the importance of timely conflict check responses from board members. David Goldberg reported that the committee expects 4-5 of the cases to be distributed for conflicts checks. Rob Rando suggested webinars as a follow up on cases where briefs were submitted and there is recent activity.
Legislative Action Committee. Colman Ragan similarly reported that there is not much activity but currently, there are lots of IP issues related to pharmaceuticals. Patent thicketing and settlement related bills are likely to move fast, and the committee will pull relevant whitepapers to send to legislators. There is much going on in the area of patent settlements, e.g., Impax case involving reverse payment and whether you can settle pharmaceutical patent cases. ACG/Chris Israel continues to monitor including Shop SAFE and INFORM Consumers Act.
99th Judge’s Dinner. Colman reported that there are over 400 attendees for the virtual dinner. The feedback he and other board members have received has been very positive. The Remo platform was good and the recorded content was well-received. The judges enjoyed the event and some stayed until the very end. The board discussed the option of keeping a virtual component for the Judge’s Dinner and potentially for the Centennial. The board members also discussed a hybrid setup for CLEs. Keeping a hybrid or virtual component allows broader audience engagement and provides convenience to members.
Programs: May 18th Presidents’ Forum fostered robust conversation and the points on both sides were well thought out and well-made. Professor Ragavan provided insight into the pro-waiver side which sees the issue as broader than CO-VID but an overall pharmaceutical products price fix. May 26thSolarWinds Privacy panel: Diana Santos reported that there is a great panel put together but will postpone until June to focus on marketing and increasing attendance. The board members discussed the benefit of adding Michael Polici to the panel. June 4th - July 9th Patent Litigation Bootcamp – Heather Schneider reported that the bootcamp will be postponed as more work needs to be done on the litigation portion. The transactional side is relatively done. John Moehringer, who retired from the board, has expressed interest in taking the lead. The board discussed other options in addition to the bootcamp that could be quicker to roll out and/or capture a different demographic. Members will put together proposals to present for the next meeting.
Rob Isackson reviewed the board liaison roles.
The meeting was adjourned at approximately 7:00 p.m.
Last First Firm/Company/Law School State Membership
Aman Taskeen University of New Hampshire School of Law New Hampshire Student
Cassady Quintin Galderma Laboratories Texas Corporate
Fix Rotem Columbia Law School New York Student
Harris Olivia Amster, Rothstein & Ebenstein LLP New York Active 3-
Keller Karen Shaw Keller Delaware Associate
Kim Michelle Fordham University School of Law New York Student
McAuliffe Daniel Fordham University School of Law New York Student
Murata Jason Axinn, Veltrop & Harkrider California Associate
Palmieri Nick Baker Botts LLP New York Active 3+
Paradisis Aurora Roger Williams University School of Law Rhode Island Student
Rephen Matthew Fordham University School of Law New York Student
Roomberg Matthew Fordham University School of Law New York Student
Surry David Foley Hoag New York Active 3+
Won Karen Mintz, Levin, Cohn, Ferris, Glovsky and Popeo New York Active 3+
Xyloportas Christopher Maurice A. Deane School of Law, Hofstra Univ. New York Student
WELCOME NEW MEMBERS
MOVING UP & MOVING ON
Mark H. Anania, formerly of McCarter & English LLP, has joined Stevens & Lee as a Shareholder.
Lisa Buckley, formerly of Pryor Cashman LLP, has joined Pashman Stein Walder Hayden PC as a Partner.
Anthony Corleto, formerly of Wilson Elser Moskowitz Edelman & Dicker LLP, has joined Gordon Rees Scully Mansukhani LLP as a Partner.
Ross Charap, Matthew Finkelstein, Celeste Moy, and Jackie Robinson, formerly of Akerman LLP, have joined Arent Fox LLP, with Charap and Finkelstein joining as Partners, Moy as Counsel, and Robinson as an Associate.
Daniel Forester, formerly of Davis Polk & Wardwell LLP, has joined Orrick Herrington & Sutcliffe LLP as a Partner.
Jeffrey Klein, formerly of Weil Gotshal & Manges LLP, has joined Clarick Gueron Reisbaum LLP as Counsel.
Lynn Oberlander, formerly of First Look Media, has joined Ballard Spahr LLP as Of Counsel.
Robert J. Rando, formerly of Taylor English Duma LLP, has joined Greenspoon Marder LLP as a Partner.
August 3, 2021
PTAB & Young Lawyers Committees on Review of PTAB Final Decisions
November 18, 2021
One-Day Patent CLE Seminar
NYIPLA Publications Committee Editorial Team
Jessica Sblendorio and Margaret Welsh
Giselle Ayala Mateus
John Kenneth Felter
NYIPLA Executive Office
2125 Center Avenue,
Fort Lee, NJ 07024, USA