Questioning Conventionality and Redefining Process in Patent Eligibility Law

by Dennis Crouch

In CareDx v. Natera, an intriguing amicus brief was recently filed by the Honorable Paul Michel (Ret.) and Professor John Duffy in support of the patentee petitioners Stanford and CareDx. The brief advocates for the clarification of patent-eligibility law, and criticizes the Federal Circuit’s handling of the case. The filing of the brief has seemingly prompted the Supreme Court to request a response from the accused infringers, after they initially waived their right to do so. This move reflects some significance of the arguments presented in the brief.  [Read the Brief]

According to Michel and Duffy, the Federal Circuit’s decision in the case overlooked the text of the Patent Act and conflicts with Supreme Court precedent such as Diehr and Cochran v. Deener. They argue that the decision fails to recognize the difference between patent eligibility (under § 101) and patentability (under §§ 102, 103, and 112). They further criticize the decision for an unduly simplified description of the invention that leaves out important details and for improper emphasis on “conventionality.”  The concept of “conventionality” is more appropriately associated with issues of novelty and nonobviousness, as regulated by §§ 102 and 103 respectively, rather than being a key criterion for patent eligibility under § 101.

The brief spends some amount of time focusing on landmark patent cases such as Diehr and Cochrane v. Deener (while rejecting Flook) to illustrate how a process can be patent eligible despite encompassing conventional elements.  And, throughout this argues that the Federal Circuit misunderstood the definition of “process,” which under 35 U.S.C. § 100(b) is defined to include “a new use of a known process.” The brief contends that this definition permits patents on new applications or improvements of known technologies, and that such improvements should be presumed to be patent eligible.  But, the Federal Circuit’s eligibility criteria of “conventionality” prohibits this interpretation even though not rooted in the Patent Act’s text or the Supreme Court’s precedent.

As with other recent eligibility briefs, this one also underscores a need to address confusion and uncertainty surrounding patent eligibility, particularly in relation to biomedical and diagnostic patents.

Now that we’re almost to June, the petition is unlikely to be decided before the recess and instead will be held-over until the fall 2023 before we get a decision on whether the court will grant certiorari.

See, A. Sasha Hoyt, The Impact of Uncertainty Regarding Patent Eligible Subject Matter for Investment in U.S. Medical Diagnostic Technologies, 79 Wash. & L. Rev. 397 (2022)




The Silent Echo: Supreme Court’s Non-Engagement with the Federal Circuit in Amgen v. Sanofi

by Dennis Crouch

Prof. Chris Holman recently characterized Amgen v. Sanofi as an “endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo.”  Although I largely align with Holman’s views, I note that the Supreme Court did not explicitly engage with Federal Circuit precedent. More specifically, the Court neither cited nor discussed any Federal Circuit or CCPA decision outside of case-specific historical documents.

The most recent enablement case invoked by the Supreme Court in Amgen is Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Court also referenced several other historically significant enablement cases, including Wood v. Underhill, 5 How. 1 (1846); The Incandescent Lamp Patent, 159 U. S. 465 (1895); and Minerals Separation, Ltd. v. Hyde, 242 U. S. 261 (1916). The Court went to lengths to present O’Reilly v. Morse, 15 How. 62 (1854), as an enablement decision, even though in both Alice and Mayo, the court had labeled O’Reilly as an eligibility decision. The approach of Amgen echoes that of the Supreme Court’s 2010 Bilski decision, which advised a simple adherence to established precedents. The only non-Supreme Court decision that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Court Justice Joseph Story while on circuit duty.

In looking at the leading Supreme Court precedent case of Holland Furniture, it is telling that the Federal Circuit has invoked this case only twice – in both instances, for discussions regarding means-plus-function claim interpretation, not enablement. Nevertheless, Holland Furniture remains a crucial decision that precludes (a) genus claims built upon on the disclosure of a single species, as well as (b) genus claims that encompass inoperable species.  The case involved a patent covering starch-based glue.  The Supreme Court explained “an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions, or even all starch glues made with three parts of water and alkali, since starch glues may be made with three parts of water and alkali that do not have those properties.”  Id.  The Federal Circuit’s failure to rely upon Holland Furniture likely stems from the fact that the case served as the foundation for Walker v. Halliburton that was later rejected by the 1952 Patent Act.

Elephants in the Room: The Federal Circuit has adjudicated numerous biotech enablement cases, providing nuanced analysis, none of which was cited or dissected by the Supreme Court.  Perhaps the simply have a tit-for-tat since the Federal Circuit so rarely cites the Supreme Court in enablement cases. The appellate court’s Amgen decision, for instance, cited many Federal Circuit opinions, but nothing from the Supreme Court.  In many ways, the two courts are simply talking past one another without disagreeing.

A critical case absent from the Supreme Court’s Amgen analysis is In re Wands, 858 F.2d 731 (Fed. Cir. 1988). In Wands, the Federal Circuit introduced a set of factual considerations to assess whether a claim is sufficiently enabled or would necessitate undue experimentation – a key factor is the amount of experimentation required.  In Amgen, these elements were handed to the jury for adjudication as mandated by the 7th Amendment. The jury in Amgen sided with the patentee, deeming the claims enabled. However, this pro-patentee verdict was overturned by the district court on JMOL, a decision subsequently affirmed by both the Federal Circuit and the Supreme Court. In its deliberation, the Supreme Court seems to reassess the Wands factors de novo without acknowledging the jury’s verdict. Intriguingly, the Supreme Court’s opinion finds substantial experimentation necessary, but does not even acknowledge the existence of a jury verdict, simply stating that “both the district court and Federal Circuit sided with Sanofi.” This omission marks a significant oversight by the Court.

While the Supreme Court’s decision in Amgen v. Sanofi seems to generally affirm the current approach of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced analysis often conducted by the Federal Circuit. In particular, the absence of reference to In re Wands and its eight-factor test, is a surprising omission. Even more disconcerting is the Court’s disregard for the jury’s verdict in the original Amgen trial, reflecting a potential underappreciation of the complexities of patent law and the factual determinations involved. It remains to be seen how this lack of engagement with Federal Circuit precedent may influence future patent law decisions.  Most likely, the Federal Circuit will continue its historic approach implicitly suggested by Prof Holman and continue to ignore the Supreme Court precedent on point.

Guest Post: Piers Blewett, Bridging the Gap: IP Education for All with SLW Academy

Editor’s note: this post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here and resources from the first conference of the initiative are available here. – Jason

By: Piers Blewett, Principal at Schwegman Lundberg & Woessner (SLW)

(This post is part of a series by the Diversity Pilots Initiative, which advances inclusive innovation through rigorous research. The first blog in the series is here and resources from the first conference of the initiative are available here.)

Hello! I’m Piers Blewett, a principal at Schwegman Lundberg & Woessner (SLW), and a patent attorney who started in a place once known as Rhodesia, now Zimbabwe. My personal journey exposed me to the nuances of systemic change and the gap that can often exist when it comes to universal access to opportunities.

During the transitional period in Zimbabwe and later South Africa, I witnessed firsthand that systemic change does not always include broad availability of opportunities. Elements like knowledge transfer and mentorship can often seem out of reach, particularly for those at the beginning of these transitions.

This personal perspective was tragically echoed nearly three years ago. On May 25th, 2020, the world witnessed the heartbreaking tragedy of George Floyd’s murder at the intersection of 38th and Chicago Ave in Minneapolis, a location not far from our offices. The events etched George Floyd’s name into our collective memory, catalyzing a global outcry against systemic racism and underscoring the persistent racial disparities afflicting our communities.

This tragedy led my team and me to ponder deeply on the systemic disparities that exist in our own professional sphere in Intellectual Property (IP), and to listen carefully to those impacted by the effects of injustice. I recalled what one of my mentors taught me year ago: “if you endow people with skills and mentors, they will succeed.” With this background, we decided to act, and the SLW Academy was born.

The SLW Academy is a platform designed to democratize access to IP education and mentorship, especially for underrepresented communities. Our objective isn’t just to impart skills, but to genuinely care for our students, nurturing them in their pursuit of an IP career. We hope to empower students and help them become dynamic, proficient members of the intellectual property community by offering practical advice, useful real-world skills, and a certification to assist in resume building. The SLW Academy’s courses are free, online, and available to stream at the student’s convenience.

At the heart of the SLW Academy’s mission is the aspiration to engage students from various fields of interest and at different stages in their education.  Our focus extends to three key groups, each with distinct needs and potential:

  1. High School Students: Recognizing the importance of early exposure, we extend an invitation to high school students interested in law, science, or engineering to embark on a career path in Intellectual Property. By providing them with practical instruction and mentorship, the SLW Academy helps them explore their passions and develop a strong foundation.
  2. Undergraduate Students, Graduate Students, and Professional Engineers: The SLW Academy tailors programs for students pursuing or holding degrees in engineering, science, or mathematics. Students at this level are introduced to the intersection of law and science.
  3. Law Students and Graduates: The SLW Academy provides a bridge between legal theory and practice for both practicing lawyers and law students, empowering these individuals to enter the field of Intellectual Property law with confidence.

Historical barriers such as availability of IP-centric education or availability of mentors can be overcome at least in part through the SLW Academy. In acknowledging the individuality of each student’s journey, the SLW Academy facilitates mentorship opportunities between students interested in Intellectual Property and practitioners in the field by inviting students to engage with the material and the presenters. Guidance on a variety of careers is provided from presenters who work throughout the field.

We urge other law firms and engineering departments to join us in promoting inclusivity. The benefits of diversity are manifold, and it is crucial that we work together to ensure every voice contributes to our collective progress.

Watch Piers’ presentation on the SLW Academy during the Diversity in the Profession and Pipeline session at the fall 2022 Diversity Pilots Conference hosted at Santa Clara University (slides) or sign up for the SLW Academy webinar taking place on June 20, 2023.

Please visit the SLW Academy website to learn more about our mission. We encourage you to share the SLW Academy with others. Together, we can make a difference.

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Challenges of Proving Inventorship: Corroboration of All Inventive Facts

by Dennis Crouch

Medtronic, Inc. v. Teleflex Innovations S.A.R.L., — F.4th — (Fed. Cir. 2023)

The case involving Medtronic and Teleflex centered on five patents related to a coaxial guide catheter used in interventional cardiology procedures. These patents, US Patents 8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379, cover inventions devised to offer an “enhanced backup support” in contrast to using a guide catheter individually.

In an attempt to invalidate these patents, Medtronic launched a succession of Inter Partes Review (IPR) petitions. Despite the initial approval of the petitions, the Board eventually ruled in favor of Teleflex, the patent holder. The pivotal question on appeal was whether U.S. Patent 7,736,355 (“Itou”) could be regarded as prior art.

In a split decision, the Federal Circuit confirmed the Board’s decision, establishing that the first-to-invent law from before the America Invents Act (AIA) allowed Teleflex to antedate the prior art by demonstrating prior invention. The case underlines a situation where the transition to the AIA has resulted in the loss of certain rights for patent holders. Under the AIA’s provisions, Itou would have been considered prior art, therefore preventing Teleflex’s patenting. The also case stands out as Itou was clearly the first inventor, but this evidence was not taken into account due both to arcane pre-AIA rules and due to the IPR process focusing only on the published patent documents.

Teleflex’s patents claim a priority filing date of May 3, 2006, based on a purported conception date in early 2005. Itou’s priority application was filed in Japan in September 2004, and a year later, the US application was filed on September 23, 2005. Despite Itou pioneering the invention in Japan and filing the Japanese patent application prior to Teleflex’s invention, Teleflex arguably demonstrated an invention date that preceded Itou’s US filing date, which was critical for the court’s decision.

A crucial regulation in this context is pre-AIA 102(e), which introduces a form of ‘secret prior art’ for patent applications that are unpublished as of the patentee’s invention date. Under this regulation, a third party’s US or PCT patent application becomes prior art once published. However, the quirk of 102(e) as compared to pre-AIA 102(a) lies in the fact that these applications are treated as prior art from their filing date, not their publication date. An important subtlety is that a foreign patent filings, like Itou’s Japanese application, do not qualify as prior art under 102(e). In re Hilmer, 149 USPQ 480 (CCPA 1966).

Proving Prior Invention: The concept of ‘invention date’ is crucial in pre-AIA patent cases, and typically, this date is assumed to be the filing date of the patent application. The patentee can then furnish evidence to establish an earlier date of invention, which usually involves a sworn declaration from the inventor, corroborated by additional evidence. Perfect Surgical Techs., Inc. v. Olympus Am., Inc., 841 F.3d 1004 (Fed. Cir. 2016).

Both the Patent Trial and Appeal Board (PTAB) and the majority judges (Judge Lourie and Chief Judge Moore) concurred that Teleflex had provided adequate evidence to substantiate an earlier invention date. Judge Dyk, however, wrote in dissent.

It’s important to understand that the process of invention involves two steps – conception and reduction to practice. The majority and dissent agreed that Teleflex had provided evidence sufficient to proven both conception and the creation of a prototype before the critical date. However, reduction to practice also necessitates evidence demonstrating the suitability of the invention for its intended purpose. For complex inventions like the one in this case, the courts can require testing to establish this suitability prong. Steinberg v. Seitz, 517 F.2d 1359 (C.C.P.A. 1975). While the majority deemed the evidence of testing adequate, the dissent argued it was insufficient — with the debate focusing on the extent of corroboration required.

The majority observed, “[B]oth inventors Howard Root and Gregg Sutton testified regarding testing performed on a prototype of the claimed invention. These tests, although more qualitative than quantitative, were sufficient to confirm that the prototype would work for its intended purpose — providing increased backup support as compared with a guide catheter alone.” The judges concurred with the Board’s view that the tests did not require a direct comparison or a quantitative analysis to prove improvement in function. They also noted expert testimony suggesting “qualitative testing would have been sufficient.”

However, Judge Dyk, dissenting, questioned the lack of corroborative evidence supporting the prior testing. He cited to Cooper v. Goldfarb, 154 F.3d 1321 (Fed. Cir. 1998), to assert that “[i]n order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence.” Judge Dyk particularly concluded that every “inventive fact” should be corroborated with evidence beyond the inventors’ testimonies.

The corroborating evidence in this case included a sales presentation and two non-inventors’ testimonies. However, Judge Dyk believed that this evidence did not provide any information regarding proof of operation for the intended purpose. Specifically, there was “no specific description of what tests were performed or the results of the tests … [or] when the tests were performed and whether they were performed before the critical date.” Dissent.

The majority responded that not every detail of reduction-to-practice needs to be independently corroborated, advocating for a rule of reason. Despite agreeing with this general principle, Judge Dyk insisted that the lack of corroboratory evidence regarding testing for the intended use couldn’t be overlooked.

Judge Dyk, in his dissent, noted the lack of internal documents from Teleflex corroborating any testing during the crucial period in 2005. “Common sense, and Teleflex’s own testimony [showing record keeping in this area], suggest that these documents would exist if testing had occurred.” Dissent. He argued requiring such documents did not created an unreasonable standard for inventors seeking to enforce a patent claim. Judge Dyk’s dissent concludes that “I think that Itou has been shown to be prior art to the patents at issue and therefore could support a determination of anticipation or obviousness.”

However, the majority, led by Judge Lourie, disagreed with the dissent and upheld the PTAB’s decision in favor of Teleflex.

The attorneys for the appellants (Medtronic) were led by Tasha Bahal from Wilmer Cutler. Representing Teleflex were attorneys from Carlson Caspers, led by Derek Vandenburg.

Devil’s Dictionary of Patent Law

Longtime patent attorney Martin Abramson just sent me a copy of his short 153 page book titled The Devil’s Dictionary of Patent Law & Beyond: Tapping the Funny Bone of Patent Law.  I just spent 10 minutes flipping through and did actually laugh out loud at one of the squibs.

The Devil’s Dictionary of Patent Law and Beyond by Martin Abramson fills a long-standing humor gap in patent law. It contains diabolical definitions, hilarious cartoons, and amusing anecdotes on patent law and the general law environment in which it exists. Where there’s satire, clarity follows, and as in the original Devil’s Dictionary by Ambrose Bierce, the droll definitions in the present book have the “ring of truth.” The author has more than 40 years of IP experience and a deep knowledge of its history, so along with the patent law are showcased the little known gems of patent lore.

Also a great gift for those fortunate enough to have a patent attorney in your life.

Guest Post: Margo Bagley, The Diversity Pilots Initiative

Editor’s note: This post is the first in a series relating to the Diversity Pilots Initiative, a project co-organized by Professors Margo Bagley & Colleen Chien along with Professor Jillian Grennan that seeks to advance inclusive innovation through rigorous research. The preview blog in the series is here and resources from the first conference of the initiative, co-organized with the USPTO are available here. Below, Professor Bagley introduces herself, the project, and the series. – Jason Rantanen

By: Margo A. Bagley, Asa Griggs Candler Professor of Law, Emory University School of Law, co-inventor, and Principal, Diversity Pilots Initiative. Watch her video for Invent Together, entitled Challenges Encountered as a Diverse Inventor.

In addition to being Associate Dean for Research and Asa Griggs Candler Professor of Law at Emory University School of Law, I am an African-American woman, co-inventor on two patents, patent attorney and law professor, author of numerous articles, chapters, and books on patent law, and advisor on patent issues to governments and international organizations. And yet, it is my firsthand experience, as a member of groups that have been systematically underrepresented and overlooked in the innovation ecosystem, that gives me a deep understanding and resolve to champion diversity and inclusion in innovation and led me to co-organize, with Professor Colleen Chien and personnel from the USPTO, the first Innovator Diversity Pilots conference held at Santa Clara Law School on November 18, 2022. (video recordings and slides available here.) This blog post, and others to follow in the series, will highlight practices that have been or will be tried, tested and evaluated to increase diversity in innovation.

According to the USPTO, women represent over 50% of the workforce and 27% of STEM workers, but  comprise only 13% of inventors on patents. Moreover, while black inventors have made profound contributions to technological advances in America, it is estimated that from 1970 to 2006, black American inventors received six patents per million people, compared to 235 patents per million for all U.S. inventors.  These statistics provided part of the impetus for the conference, which was co-organized by the USPTO and co-sponsored by the law schools of Santa Clara University and Emory University, the Intellectual Property Owners Association, the US Intellectual Property Alliance, the National Academy of Inventors, the Institute for Progress, the Association of University Technology Managers, Meta, the Institute for IP and Social Justice, Finnegan, and Schwegman Lundberg & Woessner.

The conference focused on piloting: temporarily introducing new practices to learn from, combined with rigorous research methods to evaluate their effectiveness.  The day comprised a lively mixture of “Firestarter” presentations describing pilots already completed or underway, along with academic “pitches” — proposals for new pilots across a range of entities and at a variety of points along the innovation timeline. It also included a thought-provoking keynote address by Professor John List (author of the Voltage Effect) (video), exploring the importance of successful scaling of pilots to achieve measurable results, and a fireside chat with dynamic USPTO Director Kathi Vidal whose unparalleled commitment to increasing the participation of members of underrepresented groups in the patenting process is already well underway and bearing fruit. (video)

An underlying theme of the conference was the important realization that growing the percentage of Americans of all backgrounds participating in the innovation system is not only the right thing to do, it is also critical to global economic competitiveness for the United States. For many who are aware of the dismal statistics cited above but are unsure of how to impact them, the conference provided (and through its preserved recordings still provides) an empowering opportunity to identify measurable, deployable ways to pilot low risk interventions.  It also facilitated the fostering of a community of practice, the bolstering of an evidence base for what works (and, importantly, what does not), all of which can inform policy and regulatory efforts to promote diversity and inclusion in innovation and invention.

Segments explored the why and how of diversity piloting, including the case for diversity in innovation and for rigorously piloting ways of advancing it.  Firestarters described, inter alia, diversity nudges and ways of addressing organizational barriers to diversity in the innovation ecosystem such as the measurable success of opt-out vs. opt-in invention disclosure systems; affinity group creation and support in the USPTO; the PTAB LEAP program (granting 15 additional minutes of argument to a party that allows a junior associate to participate in oral advocacy); and a “moneyball”-like fellowship program successful in bringing back into the legal profession more than 200 women who left it to raise children. Pitches covered attribution practices at the Office, mentorship, and adapting the diversity pledge to the legal academy. (video)

An intrinsic feature of the conference was its effectiveness in lifting up several successful initiatives already underway, as well as resources available to stakeholders seeking where or how to begin.  It built on and featured important early efforts like the USIPA Increasing Diversity in Innovation Pledge, signed by over 50 leading companies, the USPTO Council for Inclusive Innovation (CI2)IPO Diversity in IP Toolkit, and the Santa Clara Diversity in Innovation Best Practices Guide.

Important law firm and corporate initiatives highlighted at the conference during Session 5 include’s mentorship and DEI program resources, Schwegman Lundberg & Woessner’s SLW Academy providing a comprehensive set of free patent training videos, as well as Harrity & Harrity’s multi-pronged approach to increasing innovator and patent practitioner diversity and capacity, including the Harrity Academy and Patent Pathways programs (volunteer here).  We hope at future conferences to feature even more of the work that these and other firms are doing that often is insufficiently publicized and lauded.

The conference also provided opportunities for sharing personal reflections.  Colleen Chien (the mastermind of the conference and diversity piloting approach) and I together shared ways that technical fields have provided opportunities for the advancement of women and people of color in our own families and journeys, but also stereotypes and roadblocks that may stymie progress.  We both found encouraging the variety of approaches presented during the day that bode well for the patent system’s ability to facilitate personal advancement for more Americans from all walks of life, while advancing our national interest in technological progress. (video presentation, slides)

Students in a Patent Law course I taught at Harvard Law School were assigned to watch a 1.5-hour conference segment of their choosing and write a short reaction paper on their impressions.  Their reactions were fascinating, featuring words like “shocking”, surprising”, “moving”, “jarring”, “heartening”, “wonderful”, “compelling”, “hopeful”, and “amazing”, and often linking what they heard in the conference pitches to their own lived experiences in research ecosystems prior to law school.

The second Innovator Diversity Pilots conference being planned for 2024 at Emory University School of Law, will build on the success and momentum of this first conference and will provide an opportunity to report learnings from pilots launched and/or continued in the interim.  Please check out the conference recordings and resources, stay tuned for future blog posts, and drop us a line to let us know how we can uplift your effective practices for increasing diversity in innovation too! (

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PTAB Finds Patentee Breached Duty of Candor During IPR But in Doing So Conflates Rule 56 and IPR Candor Rules

By David Hricik, Mercer Law School

In a single decision issued by several panels, the Board held that the patentee had failed to act in good faith by, boiled down, intentionally withholding material test data that was inconsistent with the arguments it was making in favor of patentability of both original and proposed substitute claims. The case is Spectrum Solutions LLC v. Longhorn Vaccines & Diagnostics LLC, IPR2021-00847 (Patent 8,084,443 B2), IPR2021-00850 (Patent 8,293,467 B2), IPR2021-00854 (Patent 8,669,240 B2), IPR2021-00857 (Patent 9,212,399 B2), IPR2021-00860 (Patent 9,683,256 B2) (May 3, 2023).

Basically, the claims were directed to a composition that would kill certain pathogens and the test data showed it didn’t.  If so, then of course the Board’s conclusion that intentionally withholding that information violates the duty of candor is itself no news.

What is worth discussing is the Board’s statement that Rule 56 applied to an IPR. It cited and quoted Rule 56 in several spots, though it also cited and quoted the IPR rules in other spots.

Why does this matter?   Citing Rule 56 is wrong. By its terms it applies only to “the filing and prosecution of a patent application…”  IPRs are not “patent prosecution.”  (Nor are ex parte re-examinations, which are subject to a different rule from both Rule 56 and the IPR rules, but I digress.). But, the Board did rely also on the IPR rules, which are the applicable ones, so what’s the problem?

That gets to the second point:  the Board’s decision masks the extraordinary breadth of the disclosure rules in IPR. Specifically, in an IPR who is subject to a duty to disclose is much broader — ridiculously broad — compared to Rule 56.

Specifically, Rule 56 only applies to inventors, practitioners, and those “substantively involved” in prosecution. 37 C.F.R. § 1.56(c) In contrast, the main rule that applies to original claims in an IPR proceeding, 37 C.F.R. § 42.11(a), applies to “parties and individuals involved” in the proceeding. Re-read that: not only is it not limited to “substantively involved,” it says “parties.”  No such language appears in Rule 56.

Another IPR rule applies when a party files a paper, and it has a different scope of “who” is subject to disclosure. Specifically, there’s an obligation to disclose inconsistent information, but it is both broader and narrower than both Rule 56 and 42.11(a): that obligation applies to “inventors, corporate officers, and persons involved in the preparation or filing of the documents or things” where the inconsistency exists.  37 C.F.R. § 42.51(b)(1)(iii)

A decade or so ago I was speaking at the Office and pointed out that the word “party” in 42.11(a) is ridiculously broad as is including inventors and corporate officers in 42.51(b)(iii) since it is not limited to those inventors and corporate officers who are at least involved in the proceeding (do you really have to call Tim Cook to see if he knows something when Apple is in an IPR? Inventors who left the company and aren’t involved?).

Would this have mattered here? Doesn’t look like it as the data that was withheld was seemingly known to the lawyers representing the patentee, but it is important in IPR proceedings to watch this trap about the scope of disclosure (and it’s also more important that the USPTO fix it…).

Some Thoughts on Amgen v. Sanofi

By Chris Holman

Much has been already been written about the Supreme Court’s recent decision in Amgen v. Sanofi, including Dennis’s prompt response. Speaking for myself, I read Amgen as an endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo. The enablement requirement is an important (and I would argue the primary) non-prior art-based doctrinal tool for policing claim scope, and as such it plays an important role in preventing inventors of pioneering inventions from laying too much claim to subsequent innovation.

As the Supreme Court observed in Amgen, although Sawyer and Man might have been the first to invent an electric lamp filament of “carbonized fibrous or textile material,” this achievement did not necessarily entitle them to a patent encompassing all electric lamps filaments constructed of this broadly defined class of material, including Edison’s subsequent, but apparently vastly superior, bamboo-based filament. Similarly, Samuel Morse’s invention of the telegraph did not mean he was allowed a patent encompassing any use of electricity “for marking or printing intelligible characters, signs, or letters, at any distance” (sounds like the internet). And in the realm of biopharmaceuticals, the discovery of an antibody capable of specifically binding a particular epitope does not necessarily justify a patent claim encompassing all antibodies specific for that epitope, including antibodies having different (or even superior) pharmaceutical function, a point raised by Sanofi in its briefing of Amgen.

For years, this has been Federal Circuit’s interpretation of the enablement requirement, which requires the scope of the patent’s disclosure to be “commensurate” with the scope of the claims. In Amgen the Supreme Court essentially paraphrased this long-standing standard, stating that “we understand [the Federal Circuit] to have recognized only that the more a party claims for itself the more it must enable. [T]hat much is entirely consistent with Congress’s directive and this Court’s precedents.”

At the same time, it has also long been understood that a patentee is not required to literally enable a person of skill in the art to make and use every embodiment falling within the scope of a patent claim in order to satisfy the enablement requirement. For example, it is uncontroversial that a patent claim broadly directed towards pharmaceutical compositions comprising a specified active ingredient is not invalid for lack of enablement simply because the claim encompasses improved formulations of that active ingredient (e.g., timed release or combination products) that are not literally enabled by the original patent.  In many cases, such formulations are sufficiently innovative to justify their own patent, sometimes referred to as an “improvement patent.”  I do not think that anything in Amgen should be interpreted as altering this fundamental understanding of the enablement requirement.

Over the last few years I have written quite a bit about the enablement requirement, particularly in the context of therapeutic antibodies and other pharmaceuticals. For those who might be interested, here are some links to those articles, along with a brief description of some of the points raised in those articles.

I will begin with two articles I co-authored with Professor S. Sean Tu, entitled Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office and Antibody Claims and the Evolution of the Written Description / Enablement Requirement.  These articles report the results of an empirical study wherein we found that over the last couple of decades patent examiners faced with antibody claims have steadily increased the use of enablement and written description rejections, and have shifted from the issuance of broad, functionally-defined antibody claims (such as the claims struck down in Amgen) to narrower, structurally-defined claims (such as the sequence-based patent claims Amgen and Sanofi have obtained on their respective products, which the Federal Circuit and Supreme Court both pointed to with seeming approval).

In another article, Amgen v. Sanofi: The Supreme Court Takes up the Enablement Requirement in the Context of Therapeutic Monoclonal Antibodies, I offered some thoughts on Amgen prior to the Supreme Court deciding the case.   The article summarizes some of the main arguments that were raised in Amgen’s successful petition for certiorari, as well as Sanofi’s brief in opposition and a number of amici curiae briefs filed by various interested parties, including the U. S. government’s brief recommending that the Court not grant certiorari.

Amgen’s petition for certiorari relied heavily upon a 2020 law review article entitled The Death of the Genus Claim (“Death”), which purports to document a dramatic shift in the Federal Circuit’s interpretation of the enablement and written description requirements that has rendered it nearly impossible to obtain a chemical genus claim that will withstand judicial scrutiny.  Perhaps Death played some role in the Court’s decision to grant certiorari.  In any event, I responded to Death with my own two-part article, entitled Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?, Parts I and II.

In Part I, I analyzed the judicial decisions upon which Death bases its claim, and explain why, in my view, the article does not substantiate its claim of a marked shift in the Federal Circuit’s interpretation and application of 112(a).  In Part II, I push back against one particular assertion made in Death, i.e., the suggestion that patentees can circumvent the Federal Circuit’s purported heightened application of 112(a) to chemical genus claims by drafting broader claims that define chemical genuses solely in structural terms, without the inclusion of any functional limitations. Part II then reviews a substantial number of judicial decisions involving chemical genus claims, and finds little evidence of a pronounced change in the application of 112(a) to chemical genus claims over the time span which Death identifies as corresponding to a purported dramatic shift in the law.

In another article, The Enablement and Written Description Requirements Through the Lens of the Federal Circuit’s Actions (As Opposed to Its Words), I observe that, when applying patent law’s enablement and written description requirements to police the scope of chemical genus claims, there can at times be a marked divergence between what the Federal Circuit says the law is and what the court actually does. For example, although the Federal Circuit has repeatedly stated that a patentee must enable the “full scope” of a patent claim in order to comply with 112(a), that is clearly not literally true – rarely if ever does a patent enable every conceivable embodiment that would fall within the scope of a patent claim, a task that would be impossible in most (if not all) cases, given the open-ended nature of most patent claims.  In Amgen, the Supreme Court expressly observed that “we review judgments of the lower courts, not statements in their opinions,” which I interpret as tacit recognition of the importance of focusing more on the actions of the Federal Circuit, as opposed to statements in the opinions that can sometimes be misleading when divorced from context.

Summary Judgment Denial and Its Ramifications for Attorney Fee Motions

by Dennis Crouch

In OneSubsea IP v. FMC Tech (Fed. Cir. 2023), the court has affirmed a district court denial of attorney fees for the successful defendant. A key holding in the case is that denial of summary judgment serves as a big flashing sign that the case is not exceptional.

OSS sued FMC back in 2015 for infringing claims found in ten different patents all relating to subsea processing of hydrocarbons (oil and gas). This includes: adding chemicals, separating water and sand from the hydrocarbons; increasing pressure; etc. The patents required a “flow diverter assembly” to “divert fluids” to and from a processing area. The parties argued about the word “divert.” In the context of the invention, the district court concluded that it required two different potential flowpaths, and that fluid flow must be forced to follow one instead of the other. And simply changing directions is not a diversion.

The two-flowpath requirement was a problem for the patentee. FMC’s accused structure just had one flowpath that passed through the processor as shown in the figure below.

The Proceedings: The district court issued its claim construction back in 2016, but rather than quickly granting summary judgment of non-infringement, it stayed the case pending outcome of parallel inter partes reviews challenging the patents’ validity. Those IPRs resulted in many of the claims being found invalid as obvious, with that determination affirmed by the Federal Circuit without opinion. In 2019, the district court lifted the stay and the case moved toward trial. The district court again refused to grant summary judgment of non-infringement. According to the transcripts, FMC’s counsel presented 3,200 pages of documents illustrating the differences between the patented claims and the accused products. Judge Bennett (S.D.Tex.) thought that depth of factual record was a bit too much for a summary judgment. “And you really think I’m going to be able to grant summary judgment on that?” Judge Bennett asked. Eventually, Judge Bennett excluded OSS’s expert testimony for misapplying its prior claim construction and granted the summary judgment of non-infringement. OSS did not appeal the dismissal.

Attorney Fees: After winning on the merits, FMC moved for attorney fees and non-taxable costs. The district court denied those costs, finding the case to be not exceptional. On appeal, the Federal Circuit affirmed, finding no abuse of discretion.

Section 35 U.S.C. § 285 permits a district court to award reasonable attorney fees to the prevailing party; with the caveat that it may only do so “in exceptional cases.” Under the 2014 decisions of Octane Fitness and Highmark, the Section 285 analysis is a flexible one with the district court having substantial discretion in its determination of whether a particular case is “exceptional” and whether fee shifting is appropriate. In this case, the court noted a “totality of the circumstances” approach should be taken on a “case-by-case” basis. The district court can consider whether the case is an outlier from others in terms of the “substantive strength of a party’s litigating position . . . or the unreasonable manner in which the case was litigated.” Octane Fitness.

Because district courts are given discretion in making these determinations, the decisions are given deference on appeal and only overturned based upon either: (1) clear error of judgment, (2) clear error in factual finding, or (3) a material error of law. (Note here, the error of law is reviewed de novo).

Deference and Successor Judges: Here, Judge Bennett stepped into the lawsuit at the very end of the case, replacing Judge Atlas who moved to senior status.  On appeal, FMC argued that no deference should be given to Judge Bennett’s decision because he had not “lived with the case.”  In Highmark, the Supreme Court grounded its decision to give deference to district court decisions upon the fact that district courts are much more into the weeds of the litigation and thus better positioned to judge exceptionally bad behavior.  Because Judge Bennett decided the case on written record without even a hearing, FMC suggested that his decision should not be given deference.   On appeal though the Federal Circuit rejected that analysis based upon caselaw from the other circuits consistently holding that deference is also given to successor judges discretionary decisions.  “The successor judge receives the same deferential review on appeal as the original judge would have received.” Slip Op.  Further, “FMC had ample notice that a successor judge would decide its § 285 motion and did not object.”

Exceptional Case: In looking at the exceptional case question, the appellate court concluded that FMC’s failure to achieve an early summary judgment was its own fault. Basically, the original motion for summary judgment was deemed “unpersuasive.”  The appellate court then explained the importance of summary judgment denial:

When a district court, fully aware of the competing contentions of the parties, declines to end the case on summary judgment and allows a plaintiff’s case to proceed, the district court may have effectively determined that the position of the party opposing summary judgment is not objectively baseless, making it nearly impossible for the plaintiff’s case (on the issue that was the subject of the summary judgment motion) to “stand out” as lacking substance at that time.

Denial of fees affirmed.

US Patent Nos. 6,637,514, 7,111,687, 8,066,076, 8,122,948, 8,272,435, 8,281,864, 8,540,018, 8,573,306, 8,746,332, and 8,776,893.

Connect & Collaborate: Unpacking the NAPP 2023 Annual Meeting & Conference

by Dennis Crouch

As a member and supporter of the National Association of Patent Practitioners (NAPP), I am looking forward to the NAPP Annual Meeting and Conference scheduled for July 19-21 in Alexandria, Virginia at the USPTO Headquarters. I invite all those invested in protecting intellectual property rights to attend, especially folks who are deep in the day-to-day business of protecting patent rights. We have a remarkable line-up of speakers this year, including the USPTO Director, Kathi Vidal.

Delving deeper into the conference agenda, we kick off on July 19th with an optional tour of Old Town Alexandria, followed by expert-led discussions on a broad range of topics from the current USPTO Pilot Programs to how to protect your practice from cyber-attacks. Thursday, July 20th, will offer another full day of sessions covering everything from responding to prior art rejections, to cultivating diversity in patent law, and best practices for PTAB appeals.  My patent law update is Thursday morning.  Finally, on Friday, July 21st, we’ll wrap up with in-depth sessions on nonce words and means plus function, invention in the corporate environment, and patent term adjustment calculation, among other nerdy patent topics.

I particularly encourage law students to attend and take advantage of the steeply discounted rate for students and academics. It’s worth noting that attendance is free for the Judiciary and Federal Government employees such as PTAB Judges and Patent Examiners. Organizers have made arrangements for discounted accommodation at the Embassy Suites Alexandria Old Town for those who book early.

If you have not been part of NAPP, this is a wonderful opportunity to join a great organization for patent practitioners, network with industry professionals, and gain practical insights into the world of patent law. I hope to see you there!

For more information and registration, click here.

Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

by Dennis Crouch

“The more one claims, the more one must enable.”

In a unanimous opinion delivered by Justice Gorsuch, the Supreme Court has affirmed the Federal Circuit’s decision invalidating Amgen’s functionally claimed genus of monoclonal antibodies. The Court held that Amgen’s patent claims were invalid due to a lack of enablement, as they failed to provide adequate guidance for making and using the claimed antibodies.

The case in question is Amgen Inc. v. Sanofi, 22-157, — U.S. — (2023) (21-757_k5g1).

Amgen’s patents cover monoclonal antibodies created by Amgen researchers which aid in reducing blood levels of low-density lipoprotein (LDL), also known as “bad cholesterol.” These antibodies inhibit the operation of a naturally occurring protein known as PCSK9, which degrades LDL receptors and contributes to high cholesterol levels. Amgen’s original patent covered antibodies having particular amino acid sequences, but later its competitor Sanofi patented another antibody with a different sequence from those disclosed and began competing.   Amgen was then able to obtain the broader patents at issue here that are not tied to any particular antibody structure or amino acid sequence. Rather, the claims cover an “entire genus” of antibodies capable of binding to specific amino acid residues on PCSK9 and consequently inhibit PCSK9 activity. Amgen subsequently sued Sanofi for infringement, prompting a defense from Sanofi challenging whether these broader claims were sufficiently enabled.

The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Sanofi characterized the methods Amgen provided for generating additional antibodies as merely a trial-and-error process, claiming that Amgen’s patents failed the enablement requirement as they sought exclusive use over potentially millions more antibodies than the company had taught how to produce. Although a jury sided with the patentee Amgen, the district court and the Federal Circuit agreed with Sanofi’s contention, ruling that Amgen did not meet the enablement requirement as a matter of law.

The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. The Supreme Court, in its decision, referenced previous cases such as Morse, Incandescent Lamp, and Holland Furniture, as establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. In simpler terms, it follows the elementary school principle: If you bring cookies to share, bring enough for everyone.

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.

The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).

Amgen v. Sanofi.

In this case, Amgen sought exclusivity for the entire class of functional antibodies, not just the 26 antibodies expressly disclosed.  Although Amgen also provided a “roadmap” for discovering more antibodies, the court found that those approaches were insufficient “research assignments” rather than a clear process for creating the additional antibodies. The Supreme Court ruled that these disclosures did not fulfill the enablement requirement as per the Patent Act, as they simply described Amgen’s trial-and-error method without providing sufficient information for skilled scientists to make the entire class of claimed antibodies.

The Supreme Court did agree with Amgen that functional/genus claims should not be held to a stricter standard of enablement. In other words, there is “one statutory enablement standard.” Nonetheless, the general principle remains that broader claims necessitate more enablement, and all claims must be enabled to their “full scope.”

The outcome of the Amgen v. Sanofi case, while significant, may not come as a surprise to those familiar with the evolution of patent law. In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies. This approach recognizes that patents should strike a balance between incentivizing inventors to disclose their inventions and ensuring that the public can freely build upon existing knowledge. Rather than granting broad and far-reaching patent rights, the trend has been towards encouraging more focused and narrowly tailored claims. This shift reflects a recognition that patents are more palatable when they offer bite-sized protection rather than providing a singular and overpowering monopoly. The ruling in the Amgen v. Sanofi case aligns with this approach, reinforcing the notion that patents should enable the creation and use of the claimed inventions while still allowing for competition and further advancements in the field.

Assessing Judicial Fitness: Judge Newman’s Alleged Cognitive Decline

by Dennis Crouch

This week, the Federal Circuit disclosed further documents from a special committee established to evaluate the potential removal of Judge Pauline Newman from active duty due to a suspected mental or physical disability that could affect her judicial capabilities. The order, dated May 16, 2023, gives a more comprehensive discussion on concerns about Judge Newman’s performance, including signs of memory issues or confusion and diminished productivity. The document also outlines an investigation involving requested medical assessments and records, which Judge Newman has declined to provide.

The committee, formed on March 24, 2023, and comprising of Chief Judge Moore, Judge Prost, and Judge Taranto, is tasked to scrutinize the complaint, deliver their findings, and propose recommendations. Successive orders on April 7, April 17, and May 3, 2023, commanded Judge Newman to undertake a neurological evaluation and neuropsychological testing, backed unanimously by the council members based on noticeable changes in her mental sharpness.  Judge Newman opposed the mandated examinations, arguing that she should have the right to choose the medical professionals conducting them and that these examinations should have boundaries.

The May 16 order reiterates the need for these examinations in light of substantial evidence suggesting a possible disability that might inhibit Judge Newman’s judicial functions. The document then elaborates on the concerns expressed by court employees about Judge Newman’s competence. Reports from employees from various departments, including the Clerk’s Office, IT, HR, and Judge Newman’s chambers, highlight issues like memory lapses, confusion, paranoia, and inability to execute simple tasks. Notably, it details frequent accusations from Judge Newman about her email and computer being hacked, and her phones being bugged, as well as difficulty with everyday tasks such as logging into the court system, misplacing court documents, and forgetting information. The Judge has also shown confusion regarding court rules and struggled with mandatory security awareness training. These issues suggest significant cognitive impairment, according to the order, warranting a medical examination.

The document further mentions that “two out of five members of Judge Newman’s staff have recently resigned and have requested to have no further contact with Judge Newman.” It adds that “Judge Newman threatened to have a staff member arrested and removed from the building,” and another staff member “asserts her Fifth Amendment right to remain silent to avoid self-incrimination when asked about her role and responsibilities in the chambers, based on her lawyer’s advice.”

Streamlining the Qualification Process: Key Changes to the USPTO Patent Practitioner Registration

by Dennis Crouch

In the US, registered patent practitioners are required to have a science or engineering background. Over the past few years, the US Patent and Trademark Office (USPTO) has been refining the qualification process. Nearly all incoming patent attorneys qualify by either (A) possessing a specific degree (such as mechanical engineering) or (B) accumulating a sufficient number of university science or engineering credits. These two methods are referred to as Category A and Category B in the General Requirements Bulletin for Admission to the Examination for Registration to Practice in Patent Cases (GRB).

The USPTO previously simplified the path for potential registrants by including typical Category B degrees under Category A. The Office clarified that “incorporating these Category B degrees into Category A will enhance operational efficiency and expedite the application process for prospective patent practitioners.” Additionally, the Office began accepting advanced degrees under Category A.

Recently, the Office has taken several more steps:

1. Instituting a three-year review process to consider adding more qualifying degrees.
2. Abolishing the rule that computer science degrees can only qualify for Category A if they are from a program accredited by the Computer Science Accreditation Commission of the Computing Sciences Accreditation Board, or by the Computing Accreditation Commission of ABET.

These minor amendments will alleviate the pressure on patent applicants and reduce the workload of the Office of Enrollment and Discipline (OED).

The updated rules also clarify the conditions for non-US citizens seeking to register as patent attorneys. According to the regulations, non-citizens living outside the US are ineligible to register as US practitioners, with the exception of Canadians under 37 CFR 11.6(c). However, a non-citizen residing in the US can gain “limited recognition to practice” before the USPTO in patent matters, provided they can demonstrate that such activities are consistent with their immigration status. The USPTO will assess (1) the applicant’s permission to reside in the United States, and (2) the applicant’s authorization to work or receive training in the United States.

These revised regulations are effective immediately.

A New Horizon: Design Patent Practitioner Bar Proposed by USPTO

by Dennis Crouch

The United States Patent and Trademark Office has proposed a rule to create a separate design patent practitioner bar. The USPTO is publishing this proposal in the Federal Register on May 16, 2023 (link below to the prepub).

As it stands today, there is a single patent bar that applies to those practicing in patent matters before the USPTO, covering utility, plant, and design patents.  And, even though design patents cover ornamentally, the current rules require that the  design patent practitioner be an engineer or scientist.

The proposed rule aims to establish an additional separate bar for those who only specialize in design patents, ensuring that they have the necessary qualifications, while opening the door to non-engineers.  The proposal appears to not affect those already registered to practice. Existing patent practitioners will continue to practice as before, and new applicants who meet the current criteria, including passing the existing registration exam, will also be permitted to practice in all patent matters, including design patent matters.

In Fall 2022, the USPTO asked for comments on proposals in this direction and received mostly positive comments. Stakeholders acknowledged that the move would encourage broader participation in the patent system.

The proposal would still have a ‘technical’ requirement, typically a degree in one of the following: industrial design, product design, architecture, applied arts, graphic design, fine/studio arts, or art teacher education. The degree requirements here align with the current hiring practices of the USPTO for design patent examiners.  In addition to the degree requirements, applicants would have to meet the other requirements to register for the bar, including taking and passing the current registration examination and passing a moral character evaluation.

The USPTO will accept comments on the proposed rulemaking through August 14, 2023 via the portal.


Certiorari Denied in Eligibility Cases

by Dennis Crouch

In spite of robust amicus backing, including from the US Solicitor General, the Supreme Court has declined to review two pending patent-eligibility petitions: Interactive Wearables v. Polar and Tropp v. Travel Sentry. These cases contended that the Alice/Mayo framework produced (1) instability and unpredictability in the law; (2) facilitated non-evidence based judgments by district courts; and (3) prohibited patenting of subject matter that has traditionally been eligible for patents.

In my perspective, these cases wouldn’t have led to pro-patentee opinions from the Supreme Court as the inventions involved were not firmly rooted in technology. Rather, the court would likely have regarded the appellate cases as correctly denying eligibility.

The case of utmost importance still awaiting judgment, in my opinion, is CareDx Inc. v. Natera, Inc. CareDx is centered around the eligibility of an important diagnostic method for early detection of transplant organ failure. In this instance, the patent holder (Stanford University) solved a significant, longstanding problem that others had been unable to resolve. However, the lower courts determined that the patent claims were improperly directed towards a law of nature. Another petition pending before the Court is the eligibility appeal in Avery Dennison Corp. v. ADASA Inc. In the Avery Dennison case, the patent for RFID unique-ID encoding was deemed eligible and therefore valid on debatable grounds. The patent challenger has petitioned the Supreme Court, arguing that the lower courts are unduly narrowing their eligibility assessment.

A further petition, Killian v. Vidal, was reportedly filed in April but has yet to appear on the Supreme Court docket. Killian’s patent application proposes a computerized algorithm for detecting “overlooked eligibility for social security disability insurance.” The petition contends that the uncertainty created by the courts, along with the non-statutory eligibility exceptions, amount to violations of the Administrative Procedure Act (APA) and Due Process. Furthermore, the petition asserts that these judge-made exceptions “overstep the constitutional authority of the courts.” This petition has a minimal likelihood of being granted.

= = = =

The court also denied certiorari in the skinny-label FDA-Patent case of Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC.

Judicial Disability and the “Great Dissenter”

Guest Post by Paul R. Gugliuzza, Professor of Law, Temple University Beasley School of Law

The judicial disability proceedings instituted against Federal Circuit Judge Pauline Newman have now spilled into litigation. As Dennis reported yesterday, Judge Newman filed a complaint in D.C. federal district court seeking, among other things, to enjoin and terminate the proceedings.

Judge Newman’s complaint contains previously unreported details about the events giving rise to the disability proceedings against her. For instance, the complaint discloses an allegation, which was previously redacted from an order written by Chief Judge Moore in the disability proceedings, that, in the summer of 2021, Judge Newman had a heart attack and underwent coronary stent surgery.

Judge Newman’s complaint responds to that allegation by stating that “[d]uring the period (June 2021 through September 2021) when Chief Judge Moore claims that Judge Newman suffered a heart attack, Judge Newman sat on ten panels and issued at least eight (including majority, concurring, and dissenting) opinions.” Chief Judge Moore’s order, for its part, noted that Judge Newman wrote many fewer majority opinions than her colleagues over the past few years.

This dispute over Judge Newman’s ability to perform her judicial duties is an unfortunate tarnish on Judge Newman’s reputation and on the image of the Federal Circuit. And, because many of the relevant events occurred behind closed doors, we might never know for sure what’s been happening.

Is Judge Newman slowing down at age 95? Quite possibly. But is she “unable to discharge all the duties of office”—the standard set by law for instituting disability proceedings?

For some insight into Judge Newman’s workload as compared to her colleagues, I used Jason Rantanen’s Compendium of Federal Circuit decisions to collect and analyze data on the number of opinions written by individual Federal Circuit judges from June 2021 (the time of Judge Newman’s alleged heart attack) through the end of 2022. Those numbers tell a complicated story.

First off, Judge Newman’s assertion in her complaint that she wrote eight opinions from June 2021 through September 2021 is pretty much accurate. Over that time period, Judge Newman wrote one majority opinion (in a veterans case) and six dissenting opinions (either partial or full). In the eighth and final case that I was able to find, Judge Newman concurred in the result but didn’t write an opinion.

How does Judge Newman’s rate of opinion writing compare to her colleagues? The table below reports the number of opinions (precedential or not) written by each Federal Circuit judge who was in active service for the entire time period of June 1, 2021 through December 31, 2022—ten judges in total.

Opinions by Federal Circuit Judges (June 1, 2021 through December 31, 2022)

As the table makes clear, Judge Newman is an outlier, having written only nine majority opinions over that 19-month period. The judge with the next lowest number of majority opinions, Judge Chen, wrote three times as many as Judge Newman. In a group of ten active court of appeals judges, we would expect that, on average, each judge would write roughly 10% of the majority opinions. Yet Judge Newman wrote barely 2% (9 of 387).

Looking at concurring and dissenting opinions complicates things though. From June 2021 through the end of 2022, Judge Newman wrote 23 of those separate opinions. (And she concurred or dissented without opinion in four additional cases.) The two judges with the next most separate opinions, Judges Reyna and Dyk, wrote roughly half as many (13 and 11, respectively).

Overall, then, Judge Newman wrote 32 opinions from the time of her supposed heart attack through the end of 2022. That’s on the low side for an active Federal Circuit judge, but it’s worth noting that Judge Chen actually wrote fewer total opinions (30) over that same period.

Is a judge who writes, on average, more than one dissent or concurrence a month “unable” to discharge her duties? Arguably not. But, then again, there are underlying questions about Judge Newman’s physical and mental health that we can’t possibly know the answers to at this point.

And nothing is helped by the often-salacious framing of these disability proceedings as, essentially, a personal dispute between a famously headstrong—and female—Chief Judge quarreling with another female judge who, regardless of recent events, is indisputably a titan of the patent bar.

Rather, Judge Moore is acting in her official capacity as chief judge of a federal court of appeals and is proceeding in accordance with the framework set by statute and by the rules governing judicial disability proceedings. Judge Newman, for her part, is contesting both the process and merits of those proceedings, as she has every right to do. It’s not a judicial “cat fight.” It’s a legal dispute among judges—including other judges on the Federal Circuit—who genuinely disagree about what’s best for the court and the litigants who appear before it.

Turning back to the opinion numbers, the nub the conflict might be Judge Newman’s propensity to dissent. Each one of her 23 separate opinions reported on the table above dissented, at least in part. Because a dissenting judge, by definition, can’t write the majority opinion, a judge who dissents a lot creates a lot more work for her colleagues. And judges are, in the end, just people. A judge who does less work on majority opinions and who regularly refuses to compromise is unlikely to win many friends. Nor is a judge who constantly dissents likely to respond well to colleagues who suggest she take senior status or retire. Even if none of the Federal Circuit’s judges say so, frustration with Judge Newman as the court’s “great dissenter” is probably at least part of the reason for this sad saga.

Petitioner’s Failure to Argue that Prior Art was Analogous to Challenged Patent Results in Reversal of IPR Decision

By Chris Holman

Sanofi-Aventis Deutschland GMBH v. Mylan Pharms Inc., 2023 WL 3311549, — F.4th — (Fed. Cir. May 9, 2023).

The “analogous arts” test is used in patent law to determine whether a particular reference is relevant for the purposes of an obviousness analysis. Under this two prong test, a reference is relevant if it is from the same field of endeavor as the invention at issue, or if it is reasonably pertinent to the problem the invention is trying to solve.  In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)

In its 2007 KSR v. Teleflex decision, the Supreme Court ruled that the obviousness analysis should be more flexible and not confined to rigid rules or tests. Rather, KSR emphasized an “expansive and flexible approach” to obviousness.  While KSR did not directly address the analogous arts test, it could be interpreted as calling for a more flexible approach allowing courts and the PTO more leeway to consider prior art from a broader range of sources as being “analogous” or “reasonably pertinent,” which in principle should make it easier for challengers to invalidate patents.

In inter partes review (IPR) proceedings, the Patent Trial and Appeal Board (PTAB) has invalidated patents claims for obviousness based on cited prior art that the PTAB found to be analogous, and until now the Federal Circuit has consistently affirmed those decisions on appeal.  Unwired Planet, LLC v. Google Inc., 841 F.3d 995 (Fed. Cir. 2016); Smartdoor Holdings, Inc. v. Edmit Indus., Inc., 707 F. App’x 705 (Fed. Cir. 2017); Toyota Motor Corp. v. Reactive Surfaces Ltd., LLP, 816 F. App’x 480 (Fed. Cir. 2020); CyWee Grp. Ltd. v. Google LLC, 847 F. App’x 910 (Fed. Cir. 2021); and Kamstrup A/S v. Axioma Metering UAB, 43 F.4th 1374 (Fed. Cir. 2022)).

On occasion, the PTAB has found cited prior art to be non-analogous, and thus irrelevant for purposes of the obviousness inquiry.  The Federal has twice affirmed those decisions on appeal.   Polygroup Ltd. MCO v. Willis Elec. Co., Ltd, 759 F. App’x 934 (Fed. Cir. 2019) and Broadcom Corp. v. Int’l Trade Comm’n, 28 F.4th 240 (Fed. Cir. 2022)).  In one reported decision, Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353 (Fed. Cir. 2020), the Federal Circuit vacated and remanded after concluding that the Board had applied the wrong standard when it determined that a cited prior art reference was not analogous art.

On May 9, in Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., the Federal Circuit held for the first time (to the best of my knowledge) that the PTAB erred in finding cited prior art to be analogous in an IPR.  Significantly, the Federal Circuit’s decision did not address the merits of the analogous art question, but instead was based entirely on the fact that the patent challenger (Mylan) had failed to allege that the cited prior art was analogous to the challenged patent (U.S. Patent No. RE47,614, which relates to pen injectors used for the delivery of drugs such as insulin).

The court observed that:

A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.” See 37 C.F.R. § 42.23. However, Mylan did not use its reply to explain how de Gennes is analogous to the ‘614 patent.

The court reversed the PTAB’s finding of nonobviousness because it had relied upon a finding that the de Gennes reference was analogous prior art, but Mylan had never made the required analogous art argument. Mylan argued on appeal that it had, in its IPR petition, effectively argued that the de Gennes reference was analogous to another other cited prior art reference, i.e., Burren, and that Burren and the challenged Sanofi patent address the “same problem.”  However, the court found Mylan’s arguments as to Burren insufficient to carry its burden because they did not directly address the challenged patent.

The court explained that:

In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent. This conclusion is reinforced by the purpose of the analogous art test, which is to examine whether a reference can be considered as prior art to the challenged patent in the first place. [The] purpose of the “prior art” must be evaluated with reference to the inventor’s purported invention disclosed within the challenged patent.


Judge Newman vs. Chief Judge Moore

I have often written about situations where Judge Pauline Newman’s position is opposed to those taken by other judges on the Federal Circuit. But today we go a step further, by actually filing a lawsuit: Newman v. Moore.  The defendant is Chief Judge Kimberly Moore along with Judge Sharon Prost, Judge Richard Taranto, and the Judicial Council of the Federal Circuit.

The lawsuit stems from the move by the Chief along with other members of the court to forcibly remove Judge Newman from office pursuant to the Judicial Conduct and Disability Act of 1980.   Of course, the Constitution indicates that impeachment is the process for removing a Federal Judge, not some internal process, even if authorized by Congress.

The lawsuit asks for the Act to be held unconstitutional; any ongoing proceedings held unconstitutional; declare any secrecy order on Judge Newman to be a violation of her rights; etc. The complaint also reveals some previously unreported allegations.

Read it here: NewmanVMooreComplaint


Comments on USPTO Proposed Fee Changes

The USPTO has proposed a major set of patent fee revisions. One purpose of the new fees is to raise revenue. It is also clear that the proposal is designed to shift patent applicant behavior along certain fronts.  You can read more at the following links. Note, that the PPAC will be holding a public hearing Thursday, May 18, 2023, from 1-3 p.m. ET.

I submitted a brief comment arguing that before any fee shifting occurs, it is essential to conduct an economic analysis to forecast the impact on USPTO revenue and on innovator behavior.  In the commentary, I outline four general categories of fees, including (1) fees designed to raise money for the USPTO, (2) fees that create a costly screen, (3) fees that shift behavior without substantially shifting rights or raising overall costs, and (4) fees that discourage certain behaviors that result in a loss of rights for users. Each of these categories has potential major impacts, but categories 2 and 4 raise special concerns.

In the commentary, I identify eight specific proposed fee changes that require special attention by the USPTO chief economist or other economic experts. These include new and increased fees for AIA Trial filings, new large costs for terminal disclaimers, and substantial increases in fees for additional claims, among others.

Read it here: ltr.20230510.FeeShifting

Can States Legislate in the AI Rights Space?

by Dennis Crouch

In Bonito Boats, Inc. v. Thunder Craft Boats, Inc., the Supreme Court addressed the issue of state laws that provide additional patent-like rights. The Court held that a Florida law prohibiting the use of a direct molding process to duplicate unpatented boat hulls was preempted by federal patent law. The Court reasoned that the Florida law conflicted with the “carefully crafted” goals of the federal patent system.

The USPTO and Courts have made clear that AI-created inventions are outside of the scope of US patent law. I think the answer is probably quite clear, but do folks think that the Bonito Boats approach would also preempt the states from from creating an exclusive-right award for AI-generated innovations?

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