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Sandoz v. Amgen: Supreme Court Avoids “Patent Dance” Questions and Gives Biosimilar Applicants Early Market Entry

Recorded on: Jun. 30, 2017
Running Time: 01:01:30

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Taken from the briefing Sandoz v. Amgen: Supreme Court Avoids “Patent Dance” Questions and Gives Biosimilar Applicants Early Market Entry recorded June 2017 in New York.

The Supreme Court rendered its decision in Sandoz v. Amgen interpreting for the first time the provisions of the Biologic Products Competition and Innovation Act (BPCIA). In what was certainly a disappointment, the Court avoided the question of whether a biosimilar applicant (BA) is 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 (known as the “patent dance”), despite the statute’s language apparently mandating disclosure. On this issue the Court merely held that the statute provides no injunction remedy to an RPS if a BA refuses to participate in the “patent dance.” The issue was remanded to the Federal Circuit to determine whether California state law (unfair competition) provides an injunctive remedy. On the other issue before it, whether a BA could only give the mandated 180-day Notice of Marketing after FDA approval, the Court reversed the Federal Circuit and held notice could be given at any time.

Lecture Topics  [01:01:30]

This Briefing was conducted by Kevin E. Noonan, Ph.D. of McDonnell Boehnen Hulbert & Berghoff LLP. Specific topics covered 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
  • The consequences for RPSs regarding remand based on state law and the interplay between individual states’ unfair competition laws and Federal preemption under the BPCIA
  • Uncertainty regarding marketing decisions and timing, as well as choice of patents to enforce by early (pre-approval) marketing notice and the implications on the litigation regime in the BPCIA
  • The impact of these decisions on the biosimilar process and future patent litigations
  • Possibilities for Congressional revisions to the statute to address the Supreme Court’s decision

Presentation Material

  • SANDOZ INC. v. AMGEN INC. ET AL.
    Kevin E. Noonan, Ph.D.
  • The Evolving World of Biosimilars Litigation
    Kevin E. Noonan, Ph.D.
Speaker(s)
Kevin E Noonan, Ph.D. ~ McDonnell Boehnen Hulbert & Berghoff LLP
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