Determining the amount of disclosure sufficient to satisfy the written description and enablement requirements of 35 U.S.C. § 112(a) can be difficult, especially in the fields of biotechnology, pharmaceuticals, and other unpredictable arts. In a recent precedential decision from the Federal Circuit (Teva Pharms. Int’l GmbH v. Eli Lilly & Co.), the appellate
With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by Chief Judge Kimberly Moore and joined by Judges Raymond Clevenger and Raymond Chen — is an
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a surprise when the Supreme Court left intact the lower courts’ invalidity ruling
Last month the Federal Circuit affirmed a PTAB inter partes review (IPR) decision finding that the University of Minnesota’s patent claim directed to the anti-cancer drug sofosbuvir was not adequately supported by the written description in the applications to which it claimed priority. As a result, the appellate court held in Regents of the University
Well Amgen, that didn’t seem to go so well.
As a follow up to our post last week, the Supreme Court heard oral arguments in Amgen, Inc. v. Sanofi (No. 21-757). While we obviously don’t have a crystal ball, the questions from the high court suggest that Amgen’s claims are about to be delivered
The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement requirement of patent law. The specific issue at hand is:
whether enablement is governed by the