Dispute Resolution Provisions of the BPCIA in Light of Amgen v. Sandoz Case Explored!

The Biologics Price Competition and Innovation Act (BPCIA) provides a regulatory pathway for approval of biological drugs as biosimilar to an existing product.  Since its passage, litigation related to patent procedures under the BPCIA have arisen. In Amgen Inc. v. Sandoz Inc., the court construed several of the patent dispute resolution and market entry provisions of the BPCIA. The court held that a biosimilar applicant need not share its biosimilar application with the reference product sponsor, or necessarily abide by the BPCIA’s patent resolution procedures. The court also held that the biosimilar applicant must provide 180 days’ pre-marketing notice to the reference product sponsor after FDA approves the biosimilar product.

In a two-hour LIVE Webcast, a notable panel of key practitioners and thought leaders brought together by The Knowledge Group will provide the audience with an understanding of all the important issues concerning Patent Dispute Resolution Provisions of the BPCIA in light of the Amgen v. Sandoz case. Speakers will also offer a discussion of the fundamentals as well as recent developments with regards to this significant topic.