By Rothwell, Figg, Ernst & Manbeck, PC.
On December 14, 2017, the Federal Circuit
issued an opinion in Amgen v. Sandoz, holding that the Biologics Price
Competition and Innovation Act of 2009 (“BPCIA,” the “Act”) preempts state law,
and thus state laws cannot be used to enforce participation in the BPCIA’s
patent dispute resolution procedures and disclosure process. In light of the
Supreme Court’s holding earlier this year that such participation is not
enforceable by an injunction under federal law and that biosimilar applicants
need not wait for approval from the U.S. Food and Drug Administration (“FDA”)
before providing the statutorily required notice of commercial marketing, this
case is a major win for biosimilar applicants and manufacturers alike.
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