The Federal Circuit has called the BPCIA’s complicated biosimilar litigation process “a riddle wrapped inside a mystery inside an enigma.” The Supreme Court’s recent decision in Sandoz Inc. v. Amgen Inc. provides a modicum of clarity by ruling that the notice of commercial marketing required under the BPCIA from a biosimilar manufacturer may be provided before FDA approval of the biosimilar is obtained.
Uncertainty continues, however, regarding the BPCIA's information exchange. The Supreme Court concluded that an injunction is not available under the BPCIA to enforce disclosure of the abbreviated Biologics License Application and manufacturing information to the sponsor. But the Supreme Court determined that it was not necessary to decide under federal law whether such disclosure was mandatory or conditional. The Court remanded to the Federal Circuit the determination whether failure to follow the disclosure "requirement" of the BPCIA was "unlawful" under California unfair competition law and, if it was, whether state law injunctive relief was preempted by the BPCIA.
The panel will discuss the Supreme Court’s decision in Sandoz v. Amgen and factors for consideration going forward, including:
- Factors to consider in deciding when and whether to provide notice of commercial marketing
- The effect of the decision on options for the patent information exchange and available remedies for failure to disclose
- How the decision may impact the selection of forum in which to bring suit
Moderator:
Cora R. Holt
Speakers:
Basil “Bill” J. Lewris
Linda A. Wadler
Date:
Wednesday, June 21, 2017
Time:
10:00 - 11:00 a.m. PDT
1:00 - 2:00 p.m. EDT
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