Supreme Court Oral Argument: Sandoz, Inc. v. Amgen, Inc.

The Supreme Court heard oral argument last week in its final IP case of the term, Sandoz, Inc. v. Amgen, Inc.

The questions presented, as laid out in the Solicitor General’s CVSG brief, are:

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) establishes an expedited process for licensing “biosimilar” versions of licensed biologic prod- ucts (“reference products”). 42 U.S.C. 262(k). In con- junction with that process, the BPCIA establishes a series of steps for the resolution of potential patent claims by the sponsor of the reference product and the biosimilar applicant. § 262(l ). Among other things, Subsection (l )(2)(A) of Section 262 provides that the applicant “shall provide to” the sponsor a copy of the biosimilar application and information about the prod- uct’s manufacturing processes. Subsection (l )(8)(A) provides that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”

1. The questions presented in the certiorari petition are (a) whether notice of commercial marketing under Subsection (l )(8)(A) is legally effective if it is given before Food and Drug Administration (FDA) approval of the biosimilar application, and, if not, (b) whether Subsection (l )(8)(A) is a stand-alone requirement that may be enforced by means of an injunction that delays the marketing of the biosimilar until 180 days after FDA approval.

2. The question presented in the conditional cross- petition is whether Subsection (l )(2)(A) creates a binding disclosure obligation that a court may enforce by injunction, or whether the sponsor’s sole recourse for the applicant’s failure to disclose the information is the right, prescribed elsewhere in the BPCIA, to commence an immediate action for patent infringement.

The recording of the oral argument is available for download or streaming at this [link].

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