Posts Tagged: "enablement"

Review Not Warranted: SG Tells SCOTUS to Scrap Amgen’s Case on Enablement Test for Biotech Patents

The United States Solicitor General (SG) on Wednesday accepted the U.S. Supreme Court’s invitation to file an amicus brief regarding Amgen’s petition for certiorari in its case against Sanofi. Amgen is seeking review of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision invalidating antibody patent claims based on a lack of enablement for genus claims. The High Court invited the SG to file a brief in April and, on September 21, the SG recommended that the Court deny the petition and said Amgen’s argument that the CAFC “erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled…. lack merit.”

Petitioner Distances Eligibility Case from American Axle, Imploring SCOTUS to Weigh in on ‘Quasi-Enablement’ Analysis

Interactive Wearables, the petitioner in yet another patent eligibility case that the U.S. Supreme Court is being asked to review, filed a reply brief on July 11 distancing its petition from that of American Axle & Manufacturing, Inc.’s, which was denied certiorari on June 30, 2022. The brief characterizes U.S. patent eligibility doctrine as being “perilously fractured” and narrows its arguments to focus on the third question presented in its petition, since the first two were addressed, and have now been rejected by the Court, in the American Axle case.

Biotechnology at the Supreme Court—Will the U.S. Government Back Amgen’s Petition?

Earlier this year, we discussed Amgen’s petition for Supreme Court review of the Federal Circuit’s affirmance invalidating several antibody patent claims based on a lack of enablement for genus claims. At that time, we believed Amgen had a slim chance of its petition being granted—mainly because the Supreme Court denied a similar petition from Idenix in 2021 (No. 20-380, January 19, 2021).
However, on April 18, the Supreme Court invited the Solicitor General to file a brief expressing the views of the U.S. government on the questions presented. The Supreme Court’s likelihood of granting cert. in any particular case increases by about 10-fold when a Solicitor General’s brief is requested, but more importantly, the Supreme Court follows the Solicitor General’s recommendation about 75% of the time.

IPWatchdog LIVE ‘Jurassic Patents’ Panel Explores Patenting Challenges for Life Sciences Innovation

On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.

CAFC Denies Amgen Petition to Reconsider Enablement Test for Biotech Patents

On June 21, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing and rehearing en banc filed by Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Amgen) in their case against Sanofi, Aventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (Sanofi). Judge Lourie was joined by Judges Prost and Hughes in a separate opinion on the denial of the petition for panel rehearing. A group of intellectual property professors; GlaxoSmithKline plc; and Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, and Merck Sharp & Dohme Corp. filed amicus briefs.