Biosimilar sponsors can avoid 'patent dance' in US, but innovators win extra exclusivity
This article was originally published in SRA
Executive Summary
Biosimilar sponsors won a partial victory in the battle over the meaning of the US biosimilars statute as an appeals court found that the patent exchange process laid out in the law is optional1. But avoiding the disclosure and negotiation procedures or 'patent dance' in the Biologics Price Competition and Innovation Act opens them up to litigation over a larger number of patents, which could be problematic for biosimilars of newer biologics.
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