Author: Warren K. MacRae

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.: Should “Intent” Be Reconsidered in 271(e)(1)?

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Appeal No. 22-1877 (Fed. Cir. March 25, 2024) Considerations of 271(e)(1), a 2-1 decision on appeal from a grant of summary judgement of non-infringement, addressed the question of whether 35 U.S.C. § 271(e)(1)’s safe harbor applies to the importation of two medical devices (transcatheter heart valve systems) into the U.S. for purposes of exhibiting the devices at a prominent medical conference that reported on the latest developments in cardiovascular medicine.

Baxalta Inc. v. Genentech, Inc.: The Federal Circuit Addresses Enablement After Amgen v. Sanofi

Baxalta Inc., v. Genentech, Inc., Appeal No. 2022-1461 (Fed. Cir. Sept. 20, 2023) is another in the line of cases where claims to biological compounds are drafted functionally and raise §112 issues. This decision was an appeal from a grant of summary judgment that held certain claims of Baxalta’s ‘590 patent invalid for lack of enablement. The technology involved antibodies for enhancing the mechanism for blood clotting to treat patients with hemophilia type A. Claim 1 of the patent recited “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.” (Emphasis added). The claim is drafted functionally; it describes what the antibody does, rather than what the antibody actually is, and it encompasses any antibody capable of achieving that function. The specification of the ‘590 patent disclosed only 11 actual antibodies that fell within the claim’s scope, and referred to generally known methods for producing and screening antibodies. Relying on the analysis provided by the Supreme Court’s recent decision, Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the court found that the ‘590 patent’s specification simply provided a roadmap for one to engage in the same iterative, trial-and-error process that the inventors used to find their 11 antibodies. It did not identify any common...