In 2023, the U.S. Supreme Court affirmed invalidity of two Amgen patents based on a lack of enablement for broad genus claims that would potentially encompass millions of antibodies. The Court1.
On January 16, 2024, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office issued a Final Written Decision in a post-grant review (PGR).
In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware that claims 1-4, 19 and 20 of Baxalta s patent.
In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4,.
Sunday, February 14, 2021
While this recent Fed. Cir. decision – Amgen Inc. v. Sanofi, Appeal No. 2020-1074 (Fed. Cir., Feb. 11, 2021) seems predictable, given the fate of antibody claims that recite the target and the function of antibody binding thereto, there are a few interesting wrinkles to comment on. A Fed. Cir. panel of Judges Lourie, Prost and Hughes, Lourie writing, affirmed the district courts finding that Amgen’s claims failed the enablement test of s. 112. Evaluating the Wands factors there are seven of them to determine whether or not the claimed antibodies would require undue experimentation to locate ones falling within the scope of the claims, the panel relied on its fairly extensive precedent, most of it unfavorable to Amgen, and concluded that “lack of enablement [was found] due to the undue experimentation required to make and use the full scope of the claimed compounds that require a particular structure and functionality.” As the panel noted