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 ..read more

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 Massach ..read more

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 the Federal Circuit applied the wrong test for obviousness by looking for a “reasonable expectation of success” in combining prior art teachings, rather than requiring a showing of “predictable results.”  Vanda contended this lower bar for obviousness threatens innovation, especially in the pharmaceuti ..read more

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 ..read more

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: When looking for comparison prior art, is the article’s function relevant in any way? Must the comparison prior art be the “same article” as claimed? Petition for Writ of Certiorari, Seirus Innovative Acc ..read more

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 – hopefu ..read more

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 ..read more

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 when Crocs sued Double Diamond and others for patent infringement of Crocs’s design patents. That case was sta ..read more

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 ..read more

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, Sal ..read more