McDonnell Boehnen Hulbert & Berghoff LLP partners Andrew W. Williams, Ph.D. and Ann C. Palma co-authored an article entitled, “Did Fed. Circ. Doom The New Biosimilar Approval Pathway?” that appears in the November 9, 2015 online edition of Law360.com. Congress passed the Biologics Price Competition and Innovation Act in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any potential patent challenges during the approval process. Nevertheless, due at least in part to the increased complexity in manufacturing and patent protection of biosimilars (as compared to small molecules), unique provisions were necessary for the BPCIA. Interpretation of these unique provisions, however, has proven to be equally complex. In the highly fractured Amgen Inc. v. Sandoz Inc. decision, the Federal Circuit, in part, concluded that the BPCIA patent resolution procedure was not mandatory, leaving open the distinct possibility that no biosimilar applicant will ever use the new biosimilar approval pathway. View the article
Note: this article originally appeared in the MBHB Summer 2015 edition of snippets publication.