IMPACT OF AMGEN INC. V. SANOFI ON PATENTING ANTIBODY-BASED THERAPEUTICS

This Note explores the patent challenges facing antibody-based therapeutics, using a study of CAR (Chimeric Antigen Receptor) T cells. CAR T cells are a type of antibody-based therapeutic that use genetically modified T cells to target and eliminate cancer cells. CAR T cells have shown remarkable ef...

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Bibliographic Details
Published inJurimetrics (Chicago, Ill.) Vol. 64; no. 2; pp. 201 - 221
Main Author Snow, Kylie
Format Journal Article
LanguageEnglish
Published Chicago American Bar Association 01.01.2024
Subjects
Antibodies
Antigens
Cancer therapies
Case studies
Competition
Immune system
Lymphocytes
Lymphoma
Pathogens
R&D
Research & development
United States > US
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Summary:This Note explores the patent challenges facing antibody-based therapeutics, using a study of CAR (Chimeric Antigen Receptor) T cells. CAR T cells are a type of antibody-based therapeutic that use genetically modified T cells to target and eliminate cancer cells. CAR T cells have shown remarkable efficacy in clinical trials for lymphoma cancers, and the global market for these products was valued at US$1.7 billion in 2021. The Note focuses on Novartis' Kymriah, which is the only CD19 CAR T cell whose patent is owned by the parent company, among the four CD19 CAR T cells approved by the U.S. Food and Drug Administration. The Note examines how the recent decision by the U.S. Supreme Court in Amgen Inc. v. Sanofi may affect antibody-based therapeutics using Novartis' patent and its competitors as a case study. The Amgen Inc. v. Sanofi decision invalidated Amgen's patents for lack of enablement. This may create opportunities for competitors to design around antibody-based patents by making derivatives based around what is said to not be enabled in the patent. The Note also discusses the implications of Amgen Inc. v. Sanofi for the research and development incentives and litigation activities of biopharmaceutical companies, as well as for the patent system. The recent move by the Supreme Court to narrow enablement requirements for antibodybased therapeutics in Amgen Inc. v. Sanofi enhances the ability to invalidate antibodybased patents and allows for increased ability of competitors to patent derivatives of already patented antibody-based therapeutics.
ISSN:0897-1277
2154-4344