Alan Clement, Chair of Locke Lord’s Intellectual Property Department, commented on the U.S. Court of Appeals for the Federal Circuit (CAFC), which held that Novartis’ Sandoz unit cannot be compelled under any state law to give Amgen 180 days’ notice of launching a biosimilar version of Amgen’s leukocyte growth factor Neupogen® since state laws cannot preempt federal laws.
Clement said that the CAFC “has closed the door on what remedies remained available to a brand biologic company in terms of a biosimilar applicant who is refusing to engage in the ‘patent dance’ under the BPCIA after the Supreme Court ruling.” He also noted: “The CAFC decision does not leave Amgen without recourse. They can still maintain their normal patent infringement rights outside the BPCIA and, in fact, there is a current case pending.”
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