RESPONDENT:Amgen Inc., et al.
LOCATION: United States Court of Appeals for the Federal Circuit
DOCKET NO.: 15-1039
LOWER COURT: United States Court of Appeals for the Federal Circuit
CITATION: US ()
GRANTED: Jan 13, 2017
Facts of the case
The Biologics Price Competition and Innovation Act of 2009 established a process for the Food and Drug Administration (FDA) to license “biosimilar” products: products that are “highly similar” to already-approved biological products. Under the Act, biosimilar product applicants must provide notice to the seller of the original product at least 180 days prior to the first commercial marketing of the biosimilar product. The Act also requires the biosimilar seller to provide the original seller with the details of its application within 20 days of receiving notice of FDA review.
In May 2014, Sandoz Inc. filed an application for FDA approval of its product Zarxio, which was highly similar to Amgen Inc.’s product Neupogen (both products are bone marrow stimulants). On July 7, 2014, the FDA notified Sandoz that its application was under review, and the next day, Sandoz notified Amgen of the application. Later that month, Sandoz informed Amgen that it would not disclose the details of its application as required by the Act. On March 6, 2015, the FDA approved Sandoz’s application; Sandoz then notified Amgen of the FDA’s approval.
In October 2014, Amgen sued Sandoz and claimed that Sandoz violated the Act because it failed to disclose the details of its application and did not give proper notice of commercial marketing before the FDA’s approval of its biosimilar product. The district court held that failure to disclose application details under the Act does not authorize the original seller to receive damages from the biosimilar product seller or prevent the sale of the biosimilar product. The court also held that an applicant may give notice of commercial marketing before FDA approval. The U.S. Court of Appeals for the Federal Circuit vacated the district court’s ruling and held that effective notice may only be given after the FDA has approved the application. Therefore, Sandoz’s notice was effective in March 2015 rather than July 2014, and Sandoz could not sell its biosimilar product until 180 days after the March 2015 notice. The court also held that, because the Act only permits remedies based on patent infringement claims, Sandoz’s failure to disclose the details of its application did not violate the Act. Both parties filed petitions for writs of certiorari which were granted and consolidated.
Under the Biologics Price Competition and Innovation Act of 2009, can notice of commercial marketing of a “biosimilar product” be effective if given prior to approval by the Food and Drug Administration?
Does the notice requirement delay sale of biosimilar products by 180 days after notice?
- Does the Act only permit a remedy for a claim of patent infringement?