Term: 2016
Docket: 15-1039
Sandoz Inc. v. Amgen Inc.
- Pro
15-1039 SANDOZ INC. V. AMGEN INC. DECISION BELOW: 794 F.3d 1347 CONSOLIDATED WITH 15-1195 FOR ONE HOUR ORAL ARGUMENT. CERT. GRANTED 1/13/2017 QUESTION PRESENTED: In the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), Congress created an abbreviated regulatory pathway for the Food and Drug Administration ("FDA") to license "biosimilar" products-i.e., products that are "highly similar" to approved biological products. 42 U.S.C. § 262(i)(2). The BPCIA's "Notice of commercial marketing" provision states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product "not later than 180 days before the date of the first commercial marketing of the biological product-licensed under" this abbreviated pathway. Id. § 262(l)(8)(A) (emphasis added). The Federal Circuit concluded that a biosimilar applicant "may only give effective notice of commercial marketing after the FDA has licensed its product." App., infra , 20a (emphasis added). As the dissenting judge recognized, the Federal Circuit turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided-delaying the launch of all future biosimilars by six months. The Federal Circuit transformed the notice provision into a stand-alone requirement unconnected to the patent resolution provisions of the BPCIA. It also disregarded the only remedy provided by Congress-the right to initiate patent litigation-and instead created its own extra-statutory injunctive remedy to bar the launch of FDA-approved biosimilars. The questions presented are: Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a stand- alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper. LOWER COURT CASE NUMBER: 2015-1499
The U.S. Supreme Court case Sandoz Inc. v. Amgen Inc., 2016, revolved around the interpretation of a statute in the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA outlines procedures for resolving patent disputes between manufacturers of original biologic drugs and companies seeking to market biosimilar versions of those drugs. In this case, Sandoz sought approval from FDA to market a biosimilar version of Amgen's drug Neupogen before its patent expired but did not provide Amgen with their application as required by BPCIA. This led to litigation where both parties claimed that the other had violated provisions within BPCIA. The Supreme Court ruled in favor of Sandoz on two key issues: firstly, it held that an injunction was not available under federal law compelling disclosure; secondly, it clarified that applicants may give notice prior to obtaining licensure from FDA which would allow them to commercially launch their product immediately upon receiving approval.
In the dissenting opinion for Sandoz Inc. v. Amgen Inc., Justice Breyer argued that the court should have deferred to the interpretation of the Biologics Price Competition and Innovation Act (BPCIA) by Food and Drug Administration (FDA). He believed that FDA, having technical expertise in this area, was better equipped to interpret complex statutory schemes like BPCIA than courts. The majority's decision not to defer could lead to different interpretations of federal law across various circuits which would create confusion among parties who need clear guidance on how they are expected to behave under federal law. Furthermore, he disagreed with the majority's conclusion that a biosimilar applicant may provide notice before or after receiving FDA approval; instead arguing that such notice can only be effective once it is certain what product will be marketed and when.
