In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20 patents in certain categories that can be asserted by a Reference Product Sponsor (RPS) in BPCIA
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FDA Seeks Input on Biosimilar Product Development Guidance
On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”). The FDA specifically seeks “input on whether biosimilar product
Genzyme Sues Sarepta for Infringement of Gene Therapy Patents
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively, “Sarepta”). Genzyme alleges that Sarepta’s manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne muscular dystrophy—infringes U.S. Patent Nos.
Recent PTAB Developments for Regeneron’s Aflibercept-Dosing Patents
There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents.
On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs at issue were brought by
FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and Cosmetic Act. The platform technology program was included as part of the PREVENT Pandemics Act “to bring significant
FDA Approves Sandoz’s ENVEEZU™ (aflibercept-abzv)
On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). According to Sandoz, the FDA also “provisionally determined that ENVEEZUTM would be interchangeable with the reference medicine [EYLEA] as
Amgen Files BPCIA Complaint Against Samsung Bioepsis Regarding Denosumab
On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the third BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz and Celltrion, also filed in the
EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products:
- Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius Kabi Deutschland GmbH’S OTULFI
Acuitas File Complaint Against Alnylam for Declaratory Judgment of Co-Inventorship of Lipid Particle Patents
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint (1-24-cv-00816) on July 12 against Alnylam Pharmaceutical Inc. (“Alnylam”) in the U.S. District Court for the District of Delaware, alleging incorrect inventorship of seven U.S. Patents related to COVID-19 mRNA-LNP vaccines, namely U.S. Patent Nos. 11,246,933 (“the ʼ933 patent”), 11,382,979 (“the ʼ979 patent”), 11,590,229 (“the ʼ229 patent”), 11,612,657
FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.” The draft guidance is designed to “provide[] answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . . made to licensed biosimilars