The Impact of Amgen v. Sandoz

On March 13, 2015, the District Court for the Northern District of California (No. 14-cv-04741) will hear arguments as to whether the exchange of patent information under the Biologics Price Competition and Innovation Act (“BPCIA”) is mandatory, or whether biosimilar applicants can choose to opt out of the “Patent Dance” based on the level of certainty they want regarding patent infringement issues before they launch their products.

Elaine Herrmann Blais and Alexandra Lu provided insight during this webinar on the impact the case will have on the BPCIA regulatory pathway for biosimilars.

Download the slides from this webinar.