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Expert Analysis

'Patent Dance' Ruling Means Sponsors Must Plan Ahead

By Justin Weiner and Sara Margolis (December 20, 2017, 1:04 PM EST) -- On Dec. 14, 2017, the Federal Circuit ruled that the Biologics Price Competition and Innovation Act of 2009 preempts any potential state law remedies for failure to comply with certain provisions of the BPCIA. While this holding leaves open many questions about what kinds of disclosures comply with the BPCIA's requirements, it clarifies the penalties (or lack thereof) if a biosimilar applicant fails to comply with those requirements: The applicant loses control over which of a sponsor's patents get litigated preapproval, but it faces no other legal consequence for a lack of disclosure....

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