News

News

Regeneron Dismisses IPR Appeals and Disclaims EYLEA® (aflibercept) Patents

by Robert S. Schwartz, Ph.D.
July 31, 2024

On July 8, 2024, Regeneron, Mylan, Celltrion, and Apotex jointly stipulated to the dismissal of CAFC Appeal Nos. 23-1395 and 23-1396, appealing the Final Written Decisions finding all challenged claims of U.S. Patent Nos. 9,254,338 and 9,669,069 unpatentable in IPR2021-00880 (IPR2022-00257 and IPR2022-00301 joined) and IPR2021-00881 (IPR2022-00258 and IPR2022-00298 joined).  The patents recite method of treatment claims for the use of a VEGF antagonist such as EYLEA® (aflibercept) in angiogenic eye disorders.

On July 23, 2024, the PTAB granted Regeneron’s request for adverse judgment after disclaiming the claims of U.S. Patent No. 11,253,572, challenged by Samsung Bioepis in IPR2023-00884 (and joined IPR2024-00260 (Celltrion) and IPR2024-00298 (Biocon)).  The patent also recited method of treatment claims using aflibercept to treat angiogenic eye disorders.

On July 30, 2024, the PTAB granted Regeneron’s request for adverse judgment after disclaiming claims 10-12, 17-19, 21, 25-28, and 33 of U.S. Patent No. 10,888,601 (“the ’601 patent”), challenged by Samsung Bioepis in IPR2023-00739 (Biocon IPR2024-00201 joined).  Similar to the other patents, the ’601 patent recited method of treatment claims using aflibercept to treat angiogenic eye disorders.  Prior to the institution decision, Regeneron disclaimed the other claims (13-16, 20, 22-24, 29-32, 46-47) of the ’601 patent challenged in this IPR.  In January 2024, the PTAB found claims 1-9, 34-39, 41-43, and 45 of the ’601 patent unpatentable as anticipated in a Final Written Decision in Mylan’s IPR2022-01226 (IPR2023-00533 (Celltrion) and IPR2023-00566 (Samsung Bioepis) joined).  An appeal of this Final Written Decision is pending (CAFC 24-1567).

Previously, a number of other EYLEA® patents have been invalidated in IPRs filed by biosimilar manufacturers, through Final Written Decisions and disclaimers, including U.S. Patent Nos. 10,130,681 (Final Written Decision finding all challenged claims unpatentable), 10,406,226 (disclaimed), 10,464,992 (disclaimed), and 10,857,205 (disclaimed).  To date, the validity of two EYLEA® patents challenged in Post Grant Review proceedings have been upheld: U.S. Patent No. 10,857,231 (PGR2021-00117 by Celltrion, institution denied) and 11,253,572 (IPR2022-01524 by Apotex, institution denied).

Regeneron has prevailed in biosimilar challenges in district court, primarily on U.S. Patent No. 11,084,865 (the ’865 patent), with numerous claims being held valid and infringed by Biocon’s Yesafili™ (aflibercept-jbvf) in December 2023 (Case No. 1:24-md-03103 (N.D.W. Va.)) (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™).  Since that ruling, Regeneron has obtained preliminary injunctions based on the ’865 patent against the commercial launch of Samsung Bioepis’s Opuviz™ (aflibercept-yszy), Formycon’s Ahzantive® (aflibercept-mrbb), Celltrion’s CT-P42 (aflibercept, aBLA pending), and awaits a decision on its motion for a preliminary injunction against Amgen’s ABP 938 (aflibercept, aBLA pending) (Case No. 1:24-md-03103 (N.D.W. Va.)) (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars).  These cases and related appeals of the preliminary injunctions are currently pending.

Regeneron reported EYLEA® sales of $5.72 billion in 2023.

For more information about these and other biosimilar patent disputes, please visit BiologicsHQ.

 

_____________________________________________________

The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

    Disclaimer

    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates

      captcha