Biosimilar sponsors won a partial victory in the battle over the meaning of the biosimilars statute as an appeals court found that the patent exchange process laid out in the law is optional. But avoiding the patent dance opens them up to litigation over a larger number of patents, which could be problematic for biosimilars of newer biologics.
In a July 21 decision, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit...
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