2 minute read

MBHB Partner Kevin Noonan Authors DDNEWS Article Entitled, "Patent Docs: Federal Circuit changes the rules for biosimilar litigation"

McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “Patent Docs: Federal Circuit changes the rules for biosimilar litigation” that appears in the November 2015 online edition of DDNEWS. The Biologics Price Control and Innovation Act (BPCIA) is a part of the omnibus healthcare reform bill commonly referred to as “Obamacare” and, in July, the Court of Appeals for the Federal Circuit (which rules on all aspects of patent law) rendered a seriously fractured decision construing the terms of the law for the first time, in Amgen v. Sandoz. The appeal was from a district court decision on two aspects of the law: first, whether a biosimilar applicant must hand over a copy of its application and any relevant manufacturing information to the biologic drug maker (called the “reference product sponsor” in the bill, or RPS) and whether a biosimilar applicant can give the required 180-day notice to the RPS that she will begin commercial marketing. view the article