It has been nine months since the Supreme Court’s Sandoz v. Amgen decision regarding the Court’s first interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The Federal Circuit has taken on several aspects of the BPCIA, most notably concerning the exchange of confidential information at the outset. Litigants continue to test the bounds of the BPCIA, and we will share trends and tips for cases going forward. Meanwhile, FDA continues to approve biosimilar applications, and has issued several draft guidances for the industry.
- The nuts and bolts of the nine patent provisions of the BPCIA for patent litigants
- What we have learned from the first BPCIA litigations, with a particular focus on the exchange of confidential information
- How the first biosimilars manufacturers obtained licenses from FDA
- What FDA has said on a determination of interchangeability and whether that could be on the horizon.
Wednesday, April 11, 2018
12:00 P.M. – 1:30 P.M.
Please contact Meghan Schilt at firstname.lastname@example.org if you have additional questions.