As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to establish the Drug Price Negotiation Program (“the Program”; see here for a full recap of the Program’s structure). The IRA instructed
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PTAB Institutes Sarepta’s IPR
As we previously reported, REGENXBIO’s litigation against Sarepta, alleging infringement of U.S. Patent No. 11,680,274 (the “’274 patent”) by Sarepta’s gene therapy product, was stayed pending resolution of Sarepta’s IPR against the ’274 patent.
The PTAB now has granted institution of Sarepta’s IPR, which challenges claims 1, 3-6, and 8 of the ’274 patent as…
Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar
By Kevin DeJong
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv). This is the fifth BPCIA litigation regarding aflibercept, following Regeneron’s litigations against Biocon/Mylan, Samsung Bioepis, and Formycon, and Amgen, which have been consolidated for pretrial proceedings in a…
FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use Authorization (“EUA”) was also granted for the updated vaccine for individuals aged 6 months to 11 years old. According to Moderna, the updated…
FTC Comment on FDA Draft Guidance on Interchangeability
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . . made to licensed biosimilars and licensed interchangeable biosimilars.”
Last…
Del. Judge Connolly Says Preambles Are Limiting, Cites Alice in Wonderland, and Invites the Federal Circuit to Weigh In
Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly issued a memorandum opinion construing the claim term “vaccine” in one of the asserted patents (U.S. Patent No. 11,590,229). The parties’…
EMA Accepts Marketing Authorization Application for Alvotech’s AVT06 (aflibercept)
On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) EYLEA (aflibercept). Alvotech states that it expects that the process to obtain final market authorization could be completed by the third quarter of 2025. According…
Proposed BPCIA Reform Legislation Likely To Have Little Effect Even If Passed
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…
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…
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…