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Biotechnology › Pharmaceutical Patents › Appeals

Venable LLP

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

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On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more

White & Case LLP

Federal Circuit Clarifies Standard for Patent Conception in Ongoing CRISPR Dispute

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On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit issued a long-awaited decision in Regents of the University of California v. Broad Institute (Nos. 22-1594, 22-1653) addressing priority for disputed...more

Parker Poe Adams & Bernstein LLP

Life Sciences Companies Have New Avenue to Challenge Patent Applications After Federal Court Ruling

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Drugmakers and other companies in the life sciences industry seeking to invalidate patents have another arrow in their quiver thanks to a recent federal court decision....more

Proskauer - The Patent Playbook

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi...

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The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,...more

Knobbe Martens

Jepson Claim Preamble Requires Written Description Support for Conventional Aspects of the Invention

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IN RE: XENCOR, INC. Before Hughes, Stark, and Schroeder (sitting by designation).  Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. To provide adequate written description for a Jepson claim,...more

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

Harris Beach Murtha PLLC

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

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Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

Haug Partners LLP

Can Biopharma Functional Genus Patent Claims Be Resuscitated?

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An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sanofi (Fed. Cir. 2021)

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A little less than four years ago, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement...more

Knobbe Martens

Federal Circuit Review | July 2015

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Nunc Pro Tunc Assignments Insufficient To Confer Retroactive Standing - In ALPS SOUTH, LLC v. OHIO WILLOW WOOD CO., Appeal Nos. 2013-1452, 2013-1488, 2014-1147, and 2014-1426, the Federal Circuit reversed the denial of a...more

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