All posts by Holman

UMKC School of Law Wins National Patent Application Drafting Competition

Patent

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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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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“Bald Girls Do Lunch” Unable to Sway the Federal Circuit in Case Involving Deuterated Drug for Alopecia Areata

Patent,

By Chris Holman

Sun Pharmaceutical v. Incyte, 2023 WL 5370639, Not Reported in Fed. Rptr. (Fed. Cir. Aug. 22, 2023)

Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”).  AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health.  Indeed, in severe cases, AA can lead to chronic depression.”

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