Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Trade Marks

Regeneron Receives Adverse IPR Judgment After Disclaiming Rights to US Aflibercept Formulation Patent

Feb 21, 2024

On 21 February 2024, the US Patent Trial and Appeal Board (PTAB) entered an adverse judgment against Regeneron in inter partes review proceeding IPR2023-00462.  The IPR was commenced by Celltrion and Samsung Bioepis in relation to Regeneron’s aflibercept formulation patent no. 10,464,992 (‘992 Patent) and was instituted on 11 December 2023.  The adverse judgment was entered after Regeneron filed a statutory disclaimer with the US Patent Office on 17 January 2024 relinquishing its rights to all claims of the ‘992 Patent “for the sake of efficiency, as the patent is no longer needed”.

The ‘992 Patent is one of numerous US Eylea® (aflibercept) patents asserted by Regeneron against Samsung Bioepis in infringement proceedings commenced in November 2023 and December 2023 in the United States District Court for the Northern District of West Virginia.  Patent litigation asserting the ‘992 Patent was also brought by Regeneron against Formycon and Celltrion in November 2023 and Amgen in January 2024.

In August 2022, Regeneron sued Mylan and Biocon for infringement of 24 patents relating to Eylea®, including the ‘992 Patent.  Regeneron subsequently reduced its asserted patents to three for a “first wave trial”, excluding the ‘992 Patent.  Judgment was issued in that matter on 27 December 2023, with detailed reasons published on 31 January 2024.