Amgen v. Sandoz: Federal Circuit Interprets “Patent Dance” Provisions of BPCIA to Permit Biosimilar Applicant to Refuse to Disclose Application and Manufacturing Information

October 5, 2015 | 12:00-1:00 p.m. CT | Webinar

MBHB Partner Dr. Kevin E. Noonan is a featured presenter at this one-hour webinar sponsored by Practising Law Institute (PLI).

Overview

The Court of Appeals for the Federal Circuit interpreted for the first time provisions relating to patent infringement contained in the Biologic Products Competition and Innovation Act (BPCIA) in Amgen v. Sandoz. Although the decision was seriously fractured, the consequences are clear. First, a biosimilar applicant is not required to disclose to the reference product sponsor (i.e., the innovator biologic drug maker, RPS) either its application to the FDA for approval or any relevant manufacturing details, despite the statute’s language apparently mandating disclosure. In doing so two members of the panel agreed with the trial court, that the presence in the law of provisions providing the RPS with a remedy for non-disclosure by the biosimilar applicant rendered such disclosure optional. Accordingly, Amgen was not entitled to an injunction preventing Sandoz from marketing its biosimiliar version of Amgen’s NEUPOGEN drug product. Second, the biosimilar applicant cannot give the statutory 180-day notice to the RPS until receiving marketing approval from the FDA. This decision was also consistent with the trial court, despite protests from Sandoz that forcing them to wait 180 days after receiving approval unjustly extended the RPS’s exclusivity period.

This briefing will be conducted by Kevin E. Noonan, Ph.D. of McDonnell Boehnen Hulbert & Berghoff LLP.

Specific topics covered by this briefing will include:

• A review of the provisions of the statute related to patent litigation and marketing approval
  
• Statutory construction of the disclosure and marketing provisions
  
• Sandoz’ non-disclosure arguments, and how they were persuasive to the trial court and the Federal Circuit
  
• Amgen’s marketing notice arguments, and how they were persuasive to the trial court and the Federal Circuit
  
• The impact of these decisions on the biosimilar process and future patent litigations

Sponsored by: Practising Law Institute (PLI)

Register online