Amgen Inc. v. Sandoz Inc.

Amgen Inc. v. Sandoz Inc.

Amgen Inc. v. Sandoz Inc.

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 BPCIA’s 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.

Background: The BPCIA –

The BPICA provides a streamlined regulatory pathway for “biosimilars,” biologic drugs that use active substances that the FDA has already approved in an earlier application (a “reference product”). At issue in Amgen was the BPCIA’s detailed process and schedule for the exchange of technical and patent information between the biosimilar applicant and the reference product’s sponsor. In general terms, the exchange begins when the biosimilar applicant provides the sponsor with a copy of its application. The parties then engage in several rounds of exchanges and negotiations regarding the patents that should be the scope of an infringement suit, which is the expected outcome of the process. While the process is ongoing, neither party may file a declaratory judgment action on any of the patents that are included in the regulations. If the applicant does not provide a copy of its application or fails to complete the process, the sponsor may file suit, but the applicant may not.

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