Regeneron prevails in eye treatment dispute and immediately launches new suit
District judge ruled in favour of Regeneron confirming patent infringement by Mylan | Court recognised Mylan's success in challenging the validity of certain patents | Ruling happened while Regeneron filed a separate case against another competitor alleging the infringement of 51 patents.
Regeneron has emerged victorious as a US federal court ruled in favour of the pharmaceutical company, affirming that Mylan infringed on one of Regeneron's patents related to its eye treatment.
The verdict, delivered on Wednesday, January 27, 2023, by the US District Court for the Northern District of West Virginia, determined that Mylan had violated Regeneron's patent concerning the eye treatment Eylea (aflibercept)—a medication used for treating ophthalmic disorders.
The patents under contention include US patent numbers 11,084,865, 11,253,572, and 10,888,601, all associated with Eylea.
While Regeneron secured a victory for the '865 patent, Mylan, now part of Viatris, was not without its own success.
Judge Thomas Kleeh, presiding over the case, ruled that Mylan successfully convinced the court that some claims of the '572 patent and ‘601 patent were invalid due to obviousness.
However, Mylan faced challenges in persuading the court to invalidate the '865 patent.
The court rejected Mylan's arguments that the patent was obvious in light of prior art and found no grounds for invalidating it due to lack of written description, lack of enablement, or indefiniteness.
Case background
In 2022 Regeneron filed a complaint in the Virginian court against Mylan, alleging infringement of 24 patents.
Mylan sought the US Food and Drug Administration’s (FDA) approval for a biosimilar designed to replicate Eylea and Regeneron alleged that Mylan’s application infringed on its patents.
The complaint outlined Regeneron’s contributions to medical research, the FDA approval of Eylea, and Mylan’s filing for FDA approval in October 2021.
The lawsuit followed the completion of the Biologics Price Competition and Innovation Act’s (BPCIA) patent dance.
Additionally, in 2021 the US Patent Trial and Appeal Board granted an inter partes review of two of Regeneron’s patents related to Eylea—where the court decided that some claims made by Mylan demonstrated unpatentability, while others were dismissed.
Regeneron sues again
On the same day as the West Virginia ruling, Regeneron filed a complaint against Samsung Bioepis in the West Virginia District Court, also related to the eye treatment.
The suit alleged that Samsung Bioepis, a biopharmaceutical company specialising in biosimilars, infringed on 51 of Regeneron's patents related to Eylea.
The BPCIA allows for an abbreviated regulatory approval pathway for biosimilars, provided the applicants rely on the extensive clinical testing conducted by the innovator company.
Regeneron argued that Samsung Bioepis has not followed the BPCIA's provisions, specifically in addressing relevant patents through the required pre-litigation exchanges—the patent dance.
The lawsuit outlined that Bioepis' biosimilar product, SB15, infringed on Regeneron's patents, resulting in Regeneron seeking immediate injunctive relief.
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