Guest post by Lolita Darden: PPAC’s Bold Strategy to Transform Patent Inclusion

Guest post by: Lolita Darden, Chair, U.S. Patent and Trademark Office Patent Public Advisory Committee; Managing Partner, Darden Betts Strategic Intellectual Property Counselors; Visiting Associate Professor, George Washington University Law School.  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.)

This year the Patent Public Advisory Committee, also known as PPAC, turns 25.  Established in 1999, PPAC is a 9-member advisory committee appointed by the Secretary of Commerce. Each member serves a 3-year term, and I am starting my second year. The primary purpose of the Committee is to review the policies, goals, performance, budget, and user fees of the USPTO with respect to patents. The Committee is also charged, by statute, to advise the Director of the USPTO on these matters and to prepare a report to Congress on the advisory actions the Committee has undertaken during the calendar year. You can find the 2023 PPAC Annual Report

As the new Chair of PPAC, I look forward to collaborating with the Committee and Director Vidal to serve the interests of the American people and the IP community in ways that enhance national and global competitiveness, accelerate growth in GDP, and drive innovation and entrepreneurship.

For those of you not familiar with PPAC, another function of the Committee is to provide the Director with feedback from our constituents about initiatives being undertaken by the USPTO with respect to patent matters. In that regard, I view my role as Chair as a facilitator, working closely with Committee members to provide advice and counsel to the Director based on feedback received from our respective constituencies.

This year, PPAC will continue to work with Director Vidal to link patents and invention more explicitly to national competitiveness, through both increasing invention activity and making patent protection available to more inventors around the U.S. It is widely known that innovation is a key driver of competitiveness and long‐term economic growth. It is also known that patents are important measures of innovation. Recent studies show that significant increases in U.S. innovation are achievable by encouraging inclusive innovation, which involves bringing under-represented individuals and communities into the innovation ecosystem. For example, ,” which represents substantial potential growth to the United States economy.

In my capacity as a private citizen and law professor, I have devoted countless pro bono hours assisting under-resourced inventors with protecting their rights in intellectual property, as well as educating them regarding the benefits of protection.  Research shows that the biggest deterrent to the pursuit of IP protections by individuals from historically resourced communities is awareness.  My vision for increasing the number of participants in the innovation ecosystem from under-resourced communities is education.  Ideally, law schools and law firms would pledge to offer community-based programs educating inventors from under-resourced communities about IP basics, i.e., what is protectable, how it can be protected, and pro bono resources for pursuing protection.  I am excited to continue this work of raising awareness in an advisory role as Chair of PPAC.

One of the interesting things about PPAC is that we are composed of individuals with different backgrounds and views on the U.S. patent system and how it should operate.  Nevertheless, we have been able to find common ground in thinking about how patents can best help the nation.  In addition to inclusive innovation, the Committee will continue to work to support the USPTO’s efforts to maintain a patent system that best serves the American people and the IP community.

Three main takeaways:

  1. Role of PPAC: PPAC, established in 1999, is a 9-member advisory committee appointed by the Secretary of Commerce, serving 3-year terms. Its primary function is to review and advise on the policies, goals, performance, budget, and user fees of the USPTO with respect to patents, and to prepare an annual report to Congress on its advisory actions.
  2. Focus on National Competitiveness and Inclusive Innovation: PPAC aims to enhance national and global competitiveness by linking patents and invention more closely, promoting increased invention activity, and expanding patent protection to more inventors across the U.S. The committee emphasizes the importance of inclusive innovation, highlighting that significant increases in U.S. innovation and economic growth could be achieved by encouraging participation from under-represented groups in the innovation ecosystem.
  3. Education for Under-resourced Inventors: PPAC also aims to raise awareness and educational resources for under-resourced inventors about IP protection. This includes the vision to work with law schools and law firms to provide community-based programs on IP basics, aiming to increase the number of participants from under-resourced communities in the patent ecosystem.

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SCT: False Claims Act Actions Based Upon Fraudulently Obtained Patent Rights

by Dennis Crouch

This post walks through a new petition for writ of certiorari involving claims that Valeant Pharma defrauded the U.S. government by using fraudulently obtained patent rights prop up its drug prices. [Read the Petition]

The False Claims Act (FCA), originally enacted in 1863 to combat contractor fraud during the Civil War, imposes civil liability on anyone who “knowingly presents” a “fraudulent claim for payment” to the federal government. 31 U.S.C. § 3729(a)(1)(A). The Act allows private citizens, known as “relators,” to bring qui tam actions on the government’s behalf against those who have defrauded the government. If successful, relators can recover up to 30 percent of the damages. 31 U.S.C. §§ 3730(b)(4), (d)(2).

To prevent opportunistic lawsuits, however, Congress has sought to strike a “balance between encouraging private persons to root out fraud and stifling parasitic lawsuits” (more…)

UMKC School of Law Wins National Patent Application Drafting Competition

By Chris Holman

Last week the U. S. Patent and Trademark Office announced the winner of this year’s National Patent Application Drafting Competition (NPADC), the University of Missouri-Kansas City School of Law. I teach patent law at UMKC, and was privileged to travel to Alexandria with the team of UMKC students (pictured below, from left to right, Will Knutson, Mark Trompeter, Joe Hooper, and Lukas Fields) to watch them compete and ultimately triumph in the final round of the competition. I am sure a great deal of the credit for their success can be attributed to our adjunct faculty members teaching patent prosecution at UMKC, James Devaney (Shook Hardy & Bacon) and Jon Hines (Senior Patent Counsel at 3Shape).

I would encourage any law student interested in pursuing a career in patent prosecution to consider participating in the competition next year. In a nutshell, (more…)

What is Next for Enablement and Written Description of Antibody Claims?

by Dennis Crouch

I had been following the case of Teva v. Lilly for a few years.  Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. U.S. Patent Nos. 8,586,045, 9,884,907 and 9,884,908.  The patents cover Teva’s drug Ajovy, and allegedly cover Lilly’s Emgality. Both drugs were approved by the FDA in September 2018.  A Massachusetts jury sided with Teva and awarded $177 million in damages, including a controversial future-lost-profit award.

Although the jury sided with Teva, District Judge Allison Burroughs rejected the verdict and instead concluded that Teva’s patent claims were invalid as a matter of law for lacking (more…)

AI Visualize and the Eligibility of Innovative AI Systems

by Dennis Crouch

The recent eligibility decision in AI Visualize v. Nuance, __ F.4th __ (Fed. Cir. 2024), gives me pause to consider more general eligibility issues of AI Inventions. When does the design or creation of AI system elements qualify as an eligible invention?  In his recent article, Prof. Nikola Datzov wrote what we have all been thinking: “Innovative applications of AI are everywhere we look [and are] revolutionizing our society.”  Nikola L. Datzov, The Role of Patent (In)Eligibility in Promoting Artificial Intelligence Innovation, 92 UMKC L. REV. 1, 4 (2023).

In AI Visualize, the Federal Circuit (more…)

Seeking Clarity on Comparison Prior Art: Seirus Petitions Supreme Court in Heat Wave Design Patent Dispute

by Dennis Crouch

Seirus has petitioned for writ of certiorari in its long-running design patent dispute with Columbia Sportswear.  The petition asks two questions related to the comparison process for design patent infringement — in particular, the questions focus on what can qualify as “comparison prior art” used to provide context for the infringement analysis.

Questions presented: (more…)

Codifying Discretionary Denial of IPR Petitions

by Dennis Crouch

The USPTO recently released yet another Notice of Proposed Rulemaking (NPRM) — this one focusing on codification of IPR/PGR rules associated with non-merits based “discretionary denials” of institution as well as termination due to settlement.  This is a controversial area because of that word ‘discretion.’  Unrestricted discretion by government officials is concerning because of the potential for arbitrary or biased decisions, lacking transparency and accountability.  In that frame, these rules are beneficial because they structure and limit discretion – hopefully making the outcomes more predictable and justifiable.  A key note – the rules here focus primarily on procedure (separate briefing for discretionary denials) and substantive issues relating to parallel, serial, and cumulative petitions. Although this is an important step, they do not address discretionary denials associated with parallel litigation (or other outside factors) under Fintiv and subsequent director guidance. This is likely the most controversial area of discretionary denials that is being left out for now.

Congress clearly intended the USPTO to have substantial discretion (more…)

AI as Author: Thaler v. Perlmutter Now Before the DC Circuit

by Dennis Crouch

The leading case on copyrightability of AI created works is now pending before the Court of Appeals for the District of Columbia. The case, Thaler v. Perlmutter, No. 23-5233 (D.C. Cir. 2024), centers on Dr. Stephen Thaler’s attempts to register a copyright for an artistic image autonomously generated by his AI system that he has named the “Creativity Machine.” The U.S. Copyright Office refused registration on the basis that the work lacked the required human authorship. Thaler filed suit challenging this determination.  The parties have now filed their briefs, along with one law professor amicus brief in support of Thaler.

(more…)

False Patent Marking as False Advertising: Overcoming Dastar

by Dennis Crouch

The Federal Circuit is set to consider the use of terms like “patented,” “proprietary,” and “exclusive” in commercial advertising can be actionable under § 43(a)(1)(B) of the Lanham Act when their use is not entirely accurate. The key issue on appeal is whether the district court erred in granting summary judgment for Crocs on Double Diamond Distribution and U.S.A. Dawgs’ (“Dawgs”) counterclaim for false advertising under the Lanham Act.

This case began back in 2006 (more…)

What I’m reading from academic journals

I’m always on the lookout for interesting new scholarship related to intellectual property and innovation policy. The following are a few of the articles that I’ve been delving into this past week:

  • James Hicks, Do Patents Drive Investment in Software?, 118 NW. U. L. REV. 1277 (2024).
  • Ana Santos Rutschman, From Myriad to Moderna: The Modern Pharmaceutical Company, ___ Texas A&M University Journal of Property Law ___ (2024) (forthcoming).
  • John Howells, Ron D Katznelson, Freedom to Operate analysis as competitive necessity—the Selden automobile patent case revisited, Journal of Intellectual Property Law & Practice (2024).
  • Christa Laser, Scientific Educations Among U.S. Judges, ___ American University Law Review ___ (2025) (forthcoming).
  • Garreth W. McCrudden, Drugs, Deception, and Disclosure, 38 BERKELEY TECH. L.J. 1131 (2024).

(more…)

The Use of Mandated Public Disclosures of Clinical Trials as Prior Art Against Study Sponsors

By Chris Holman

Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024)

Human clinical trials play an essential role in the discovery, development, and regulatory approval of innovative drugs, and federal law mandates the public disclosure of these trials. Pharmaceutical innovators are voicing concern that these disclosures are increasingly being used as prior art to invalidate patents arising out of, or otherwise relating to, these trials, in a manner that threatens to disincentivize investment in pharmaceutical innovation. A recent Federal Circuit decision, Salix Pharms., Ltd. v. Norwich Pharms. Inc., illustrates the concern.  In Salix, a divided panel upheld a district court decision to invalidate pharmaceutical method of treatment claims for obviousness based on a clinical study protocol published on the ClinicalTrials.gov. website. The case garnered amicus curiae briefs filed by several innovative pharmaceutical companies in support of the patent owner, Salix Pharmaceuticals. (more…)

Proposed Changes to Patent Law’s Proper Venue Statute: Venue Equity and Non-Uniformity Elimination Act of 2024

by Dennis Crouch

Law school civil procedure courses spend very little time on proper venue because, in most cases venue is proper so long as the district court has personal jurisdiction over the defendant. However, in a quirk of history, Congress created a patent-law specific venue statute in the 1800s that severely limits where a patent case can be filed. See 28 U.S.C. 1404(b). A newly proposed bill, S.4095, sponsored by Republican Senators McConnell, Cotton, and Tillis, would moderately expand the scope of proper venue and resolve some indeterminacy regarding foreign defendants.  Although the proposal does not create a right to immediate appeal, it does set a standard for mandamus that would seem to permit immediate relief of erroneous transfer denials for improper venue. This portion of the bill is entitled (more…)

New USPTO Director Review Rules

by Dennis Crouch

The USPTO has published a notice of proposed rulemaking (NPRM) to formalize the process for Director Review of PTAB decisions. These proposed rules come in response to the Supreme Court’s decision in United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021), which underscored the necessity for the USPTO Director to have the ability to review PTAB decisions to comply with the Appointments Clause of the U.S. Constitution.  Of course, the USPTO has been operating under an interim procedure for Director Review that began soon after Arthrex, but has been updated a couple of times.  The NPRM closely follows the most recent version of the interim rules. (more…)

Patentee’s Unclean Hands

by Dennis Crouch

The Federal Circuit’s new decision in Luv’N’Care, Ltd. (LNC) v. Laurain and EZPZ, relies on the doctrine of unclean hands to deny relief to the patentee (Laurain and EZPZ), affirming the district court’s judgment.  The appellate panel also vacated and remanded the district court’s finding that LNC failed to prove the asserted patent is unenforceable due to inequitable conduct during prosecution, as well as its grant of summary judgment one of the asserted patents was invalid as obvious.  U.S. Patent No. 9,462,903. The case here involves bowls/plates attached to a mat to help avoid spills and for easy cleanup. 22-1905.OPINION.4-12-2024_2300689.

Unclean Hands: The doctrine of unclean hands is an equitable defense that bars a party from obtaining relief when they have engaged in misconduct (more…)

What I’m doing with LLM-Based GenAI Tools

by Dennis Crouch

As many of you know, I have done machine learning work for many years — starting in the 1990s while in college.  However, like most of the world, I have been surprised and amazed by the power of LLM-based GenAI technology and have been trying to figure out ways to use it both for patent practice and in my job as a law professor.  I hope that it helps me become both more effective and more efficient.

On the Patently-O side, I have been honing my approach somewhat. I tried to have a GenAI tool (like ChatGPT or Claude) simply write a blog post for me, but those attempts largely failed because the results lacked insight, and the tools continue to make up wrong answers (i.e., hallucinate).  My approach recently has been to first write a draft blog post myself, then refine it with insights from a GenAI — I typically seek input on any errors in my post and suggestions on what else I might have said.  I also have been using these tools for small idea generation if I ever have writer’s block. Although I write one or more blog posts almost every day, I also have about 1,000 unfinished posts, many of which I have been sitting dormant because I wasn’t quite sure how to wrap up.  These days when I get to a blocking point, I will typically ask an AI tool to help me brainstorm (“provide me with five ideas of what to write next”).  The ideas are often not very good, but sometimes they are good. And, I almost always find that one of them triggers an idea of what to do next.  The bottom line then is that this is helping me to finish more work, although I’m still working on improved quality.

I have also been using an AI tools for transcribing Federal Circuit oral arguments – this is a bit more complicated and required some python and API calls to make it work.  The tools do a great job with automated transcription, including catching legal phrases without much trouble. But, my current version does not distinguish between speakers.  I’m hoping this summer to finish the project of automating serialization so that the transcript looks like a real court transcript.

In my patent prosecution class, the students are busy drafting a patent application.  This year they are using a drafting tool known as Edge created by Evan Zimmerman that has an especially good chat-tool for creating a detailed invention disclosure.  It is really fun to see the students dig deeply into this. I envision GenAI assisting with lots of tasks, prior art searches (including detailed comparison to claims), office action responses, specification drafting (including multiple prophetic examples), and (more…)

Patent Term Adjustment and Obviousness-Type Double Patenting: Cellect’s Bid for Supreme Court Review

by Dennis Crouch

The Federal Circuit’s August 2023 decision in In re Cellect, LLC has set-up a significant question regarding the interplay between the patent term adjustment (PTA) statute, 35 U.S.C. § 154(b), and the judicially-created doctrine of obviousness-type double patenting (OTDP). Now, Cellect is seeking Supreme Court review, recently filing a petition for an extension of time that also indicated its intent to file. Cellect’s petition is now due May 20, 2024, and I expect significant support from the patent owner community.

Patentees often receive PTA due to USPTO delays that otherwise eat into the 20-year patent term.  A fundamental issue in Cellect boils down to whether a patentee must forfeit their PTA term extensions to avoid an OTDP invalidity finding.  This comes up in situations where a patentee has two patents that cover only slightly different inventions.  Most often this is seen in family-member continuation applications, but it can also arise when applicants file several applications all within a short period.

Under the judge-made law of OTDP (more…)

The Design Law Treaty and the Struggle for International Harmonization of Industrial Design Protection

By Dennis crouch

The international IP community is moving toward further harmonizing legal protection for industrial designs. For almost twenty years, member states of the World Intellectual Property Organization (WIPO) have been negotiating a Design Law Treaty (DLT) that would streamline and align procedural requirements for obtaining registered design rights across jurisdictions. If successful, the DLT would make it “significantly easier for small and medium-sized enterprises to obtain industrial design protection overseas as a result of simplified, streamlined and aligned procedures and requirements.”[1]  The DLT can be seen as parallel to the Patent Law Treaty (PLT) adopted in 2000 that helped to harmonize and standardize the formal patent procedures such as the filing requirements sufficient for obtaining a filing date.

Throughout this time, it has been difficult to implement almost any global IP treaty because (more…)

Guest post by Prof. Holbrook: Extraterritoriality and Patent Damages Under § 271(a)

Guest post by Tim Holbrook. Robert B. Yegge Endowed Distinguished Professor of Law and Provost’s Professor, University of Denver Sturm College of Law.

United States patents are generally territorial.  Their exclusive rights only operate within the United States and its territories.  Or so one may think reading the Patent Act.  Moreover, in a global marketplace, the territorial nature of intellectual property rights can create challenges. It would be simpler for a patent holder to just use the U.S. patent to cover foreign activity. This is especially true if a domestic act of infringement has spillover effects into other countries.

So, when – if ever – can a patent owner receive damages for foreign activity that may flow from acts of domestic infringement?

The Supreme Court answered that question   (more…)

Using AI in your Patent Practice

By Dennis Crouch

Over the past year I’ve been investigating various generative Artificial Intelligence (GenAI) tools for assisting patent attorneys in their practice.  I have a strong belief that these tools and their progeny are now fixtures in our legal environment and are being used to both improve efficient delivery of legal services and to also improve the quality of those services.  Of course the generative creativity of our LLMs go hand in hand with hidden false narratives or hallucinations. Vendors are stepping up to thread the needle here: providing valuable GenAI tools while limiting false story telling.  As we move forward some of the struggle will be a focus on how much the attorney needs to know about how the GenAI works in order to use it responsibly.

Enter the USPTO and its Wet Blanket: The USPTO has released new guidance on the use of AI tools in practice before the USPTO. (more…)