UMKC School of Law Wins National Patent Application Drafting Competition

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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,

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

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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

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Supreme Court Declines to Hear Vanda’s Patent Obviousness Appeal

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by Dennis Crouch

The Supreme Court has denied Vanda Pharmaceuticals' petition for certiorari, leaving in place a Federal Circuit decision that invalidated Vanda's patents on methods of using the sleep disorder drug Hetlioz (tasimelteon) as obvious.

Vanda had argued in its cert petition that

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AI Visualize and the Eligibility of Innovative AI Systems

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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

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

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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:

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Codifying Discretionary Denial of IPR Petitions

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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

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

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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.

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False Patent Marking as False Advertising: Overcoming Dastar

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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

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What I’m reading from academic journals

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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).

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

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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.

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

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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

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New USPTO Director Review Rules

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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.

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Patentee’s Unclean Hands

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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

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What I’m doing with LLM-Based GenAI Tools

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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,

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

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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

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

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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

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

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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  

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Using AI in your Patent Practice

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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.

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Docketing Nightmare: CPA Global wins Despite their Docketing Error; Law Firm still on the hook for Missed Deadline

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By Dennis Crouch

In a recent unpublished decision, the Georgia Court of Appeals affirmed summary judgment in favor of CPA Global Support Services, LLC ("CPA") (now part of Clarivate) against a claim of negligent misrepresentation brought by inventor James C. Robinson, M.D. and his patent holding company (Spectrum Spine).  Robinson's firm FisherBroyles had relied upon the dates erroneously entered by CPA and missed the national stage filing deadlines.  The parallel case against FisherBroyles is still pending in Georgia state court. Robinson v. CPA Global Support Services, LLC, No. A24A0405 (Ga. Ct. App. Apr. 8, 2024). CPA vs Robinson.

The case serves as an important reminder about the limitations on vendor liability for negligent misrepresentation claims in the absence of contractual privity -- and how attorneys are often stuck in the middle.

What are your thoughts on how to avoid this situation?

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Federal Circuit Affirms ITC Divided Opinion in Sonos v. ITC

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by Dennis Crouch

In a non-precedential opinion, the Federal Circuit has affirmed the US International Trade Commission's (ITC) final determination in the patent infringement dispute between Sonos and Google involving smart speaker technology. Sonos, Inc. v. Int'l Trade Comm'n, Nos. 2022-1421, 2022-1573 (Fed. Cir. Apr. 8, 2024).  The ITC had issued a split opinion - finding that Google infringed a number of Sonos speaker patents, but concluded that Google's proposed work-around was non-infringing.  Both sides appealed and the Federal Circuit's deferential standard of review resulted in a full affirmance. The outcome then

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