The Biosimilar Patent Dance: When in Doubt, List It

In Amgen v. Hospira, issued August 10, the Federal Circuit provided its latest take on the “patent dance” under the Biologics Price Competition and Innovation Act (“BPCIA”).  The Federal Circuit sets a low bar for what constitutes “a claim of patent infringement could reasonably be asserted” under BPCIA and allows a reference product sponsor to potentially identify a lot more patents at the beginning of the dance than what it can reasonably assert at the end of the dance, after receiving additional information from the biosimilar applicant.  Read Limin Zheng’s article published in Daily Journal here.


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