Posts Tagged: "enablement"

Amgen is the Answer to Alice

The Supreme Court decided Amgen Inc. v. Sanofi on May 18, 2023, nearly nine years after its decision in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). Amgen was concerned with the enablement statute of the patent law, 35 U.S.C. § 112. In comparison, Alice was concerned with the eligibility statute of the patent law, 35 U.S.C. § 101, and has been highly criticized for creating a mess of patent eligibility. At first glance, these cases are distinguishable from one another, since they deal with different aspects of the patent laws. However, statutory interpretation and analysis should be the same in both instances.

Federal Circuit Axes Antibody Claims for Hemophilia Treatment Under Amgen

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s grant of summary judgment that Baxalta, Inc. and Baxalta GmbH’s Hemophilia patent claims are invalid for a lack of enablement. The court said the facts of the case are “materially indistinguishable from those in Amgen.”… While Baxalta tried to argue its screening process does not require the type of trial and error described in Amgen and instead “predictably and reliably generates new claimed antibodies every time it is performed,” the court said “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.”

Best Practices for Conquering the Enablement Requirement After Amgen

The Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), found that antibody claims defined by their binding and blocking function lacked enablement…. The Supreme Court’s decision relied highly on the unpredictability of the art—scientists cannot always predict how substitutions of even single amino acids will affect the binding and/or blocking function of an antibody. The disclosed methods of identifying species within the scope of the claim were little more than “trial and error.”… The consensus seems to be that Amgen generally forecloses broad genus claims in the biotechnology field. The remaining questions are: Are patent applicants limited to claiming species (e., sequence listings)? What steps may a patent applicant take to obtain broader coverage?

District Court Decision Teaches Caution When Construing Claims to Encompass After-Arising Technology

Novartis is currently involved in a multi-district patent litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. In the fall of 2022, Novartis went to trial on the validity of one of the asserted patents, U.S. Patent No. 8,101,659 (“the ‘659 patent”). On July 7, 2023, the district court invalidated the patent for lack of written description despite rejecting an enablement defense based upon the same evidence. The district court’s decision highlights a clear tension between claim construction and enablement that, if left to stand, could permit pharmaceutical companies to block lower-cost generic medications with patents they did not actually invent.

Federal Circuit Nixes APA Challenge to PTAB Pilot, Cites Amgen in Enablement Analysis

Yesterday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Medytox, Inc. v. Galderma S.A. affirming a final written decision by the Patent Trial and Appeal Board (PTAB) invalidating Medytox’s patent claims covering methods for treating patients with botulinum toxin and denying a revised motion to amend patent claims. On appeal, the Federal Circuit rebuffed several challenges, including an Administrative Procedures Act (APA) challenge to the PTAB’s motion to amend pilot program, holding that the PTAB’s change in claim construction was not arbitrary or capricious, nor did it prevent Medytox from litigating construction issues.

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