On March 19, 2015, the United States District Court for the Northern District of California issued its decision in Amgen Inc. v. Sandoz Inc., construing the patent negotiation provisions of the Biologics Price Competition and Innovation Act ("BPCIA"). The court ruled that the patent negotiation provisions are not mandatory and therefore denied Amgen’s request for an injunction against Sandoz, which had not complied with the provisions. If upheld on appeal, the decision will have significant implications for the timing and posture of biosimilar patent litigation.
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