The Federal Circuit recently strengthened Regeneron's market position by upholding preliminary injunctions that prevent the launch of biosimilar versions of its leading drug, EYLEA. The decisions addressed key issues including personal jurisdiction over foreign manufacturers, the concept of obviousness-type double patenting in relation to biological products, and standards for granting preliminary injunctive relief. These rulings thwart attempts by companies like Samsung Bioepis and Formycon AG to enter the market, thus maintaining Regeneron's significant revenue stream linked to EYLEA, which is crucial for treating various serious eye conditions.
In a significant decision, the Federal Circuit has upheld injunctions that delay the launch of biosimilar versions of Regeneron's EYLEA, ensuring market exclusivity.
The rulings reinforce the importance of personal jurisdiction, patent clarity, and effective standards for injunctions in the competitive biosimilars market.
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