Supreme Court Ruling—Sandoz Inc. v Amgen Inc. et al.
In a unanimous 9–0 ruling issued on June 12, 2017, the United States Supreme Court removed a legal barrier that had delayed manufacturers from marketing new biosimilars until 6 months after Food and Drug Administration (FDA) approval.
Two cases were before the Court: Sandoz v. Amgen and Amgen v. Sandoz. Both cases involved provisions in the Biologics Price Competition and Innovation Act (BPCIA) that address regulatory and patent exclusivity periods. For example, the BPCIA stipulates that a biosimilar manufacturer (applicant) cannot file an application for a biosimilar for 4 years after the date on which the innovator product (known as the “reference product”) was first approved (licensed), and the application cannot be approved for 12 years after that initial licensure date. The 8-year period between those dates creates a window for resolving patent disputes between the biosimilar applicant and the manufacturer of the reference products (“sponsor”). The procedure for resolving patent disputes—commonly referred to as the “patent dance”—includes several rounds of information exchange between the biosimilar applicant and the reference product sponsor, with strict sequencing and timing requirements.
The BPCIA also requires biosimilar applicants to notify the reference product sponsor at least 180 days (6 months) before the applicant plans to begin commercial marketing of the biosimilar product. During that 180-day period, the reference product sponsor may seek a preliminary injunction prohibiting marketing and bring action against additional patents.
Sandoz submitted an application to the FDA in 2014 to market a biosimilar filgrastim product under the brand name Zarxio, using Amgen’s Neupogen as the reference product. Sandoz notified Amgen in 2014 that its application was being reviewed by the FDA and that it intended to market Zarxio immediately upon receiving FDA approval. Sandoz later declined to provide Amgen with a copy of the application and information describing how the proposed biosimilar would be manufactured—i.e., it “opted out” of the patent dance.
Amgen sued Sandoz for patent infringement and also claimed that Sandoz had violated the BCPIA by:
- Failing to comply with the patent dance provisions.
- Providing notice of intent to market the biosimilar before obtaining FDA approval.
Sandoz filed a countersuit, asserting that it had not violated the BPCIA.
In a 2015 ruling, the U.S. Court of Appeals for the Federal Circuit agreed that Sandoz could opt out of the patent dance. However, the court also held that the 180-day notification period is mandatory and must begin after the FDA licenses the biosimilar product. Sandoz complained that this effectively granted the reference product sponsor an additional 6 months of market exclusivity, on top of the 12 years already provided under the BCPIA.
The Supreme Court decision reversed the lower court’s judgment as to notice of commercial marketing. Writing for the court, Justice Clarence Thomas stated that biosimilar applicants may provide 180 days’ notice to reference product sponsors either before or after receiving FDA approval.
The Supreme Court did not answer the question of whether participation in the patent dance is mandatory, ruling only that reference product sponsors cannot seek an injunction under federal law to enforce this requirement. The Supreme Court remanded this issue to the Federal Circuit for further consideration.