David L. Anstaett Partner

The Food and Drug Administration recently revised its regulations governing submission and approval of new drug applications and abbreviated new drug applications. In the patent space, the America Invents Act provides a streamlined administrative process for challenging the validity of pharmaceutical (and other) patents. Congress also created an abbreviated pathway for biosimilar products, including a regulatory scheme for handling related patent disputes.

Perkins Coie is proud to sponsor the ACI 16th Annual Paragraph IV Disputes Conference which will be held November 9 -10 in New York.