Regeneron vs. Mylan: Court Upholds FDA-Approved Drug's Patent Rights
By Prashant Kotian, PhD Researcher (Chemistry), ICT Mumbai
In a landmark decision, the Court of Appeals for the Federal Circuit upheld the preliminary injunction against Samsung Bioepis Co., Ltd. (SB), prohibiting the sale of its EYLEA biosimilar in the United States without Regeneron's license. This case revolves around Regeneron's patents for EYLEA, a VEGF antagonist-based drug approved for treating several eye diseases.
Regeneron's patents, including U.S. Patent No. 11,084,865, cover VEGF-trap formulations suitable for intravitreal injection. In August 2022, Regeneron filed an action against Mylan Pharmaceuticals Inc., seeking to enforce these patents against the sale of EYLEA biosimilars. The Judicial Panel on Multidistrict Litigation consolidated all related cases in the Northern District of West Virginia.
SB, a South Korean company, filed a Biologics License Application (BLA) with the FDA to market its EYLEA biosimilar. Despite selling the finished drug product to Biogen, SB's involvement in the commercialization of EYLEA did not cease, as per the Biogen Agreement. This agreement included provisions for active participation in a joint steering committee, which extended SB's rights and responsibilities related to EYLEA.
Regeneron filed motions for a preliminary injunction against SB and Formycon, both of which were granted by the district court. The court's decision was based on personal jurisdiction over SB and the merits of Regeneron's case for a preliminary injunction, including the lack of substantial question of patent invalidity raised by SB.
The Federal Circuit affirmed the district court's holding, emphasizing the importance of Regeneron's patents in protecting its interests. The court found no reversible error in the district court's exercise of personal jurisdiction over SB and its determination of the preliminary injunction merits.
This decision underscores the significance of patent rights in the pharmaceutical industry, particularly for drugs with FDA approval. It also highlights the complexities of international agreements and their impact on patent enforcement.
https://patent-analytics.thechemsolver.com/regeneron-v-mylan-pharmaceuticals
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