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MBHB Partner Kevin Noonan Authors DDNEWS Article Entitled, "Solicitor General recommends that the Supreme Court review Federal Circuit decision in Sandoz v. Amgen"

McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “Solicitor General recommends that the Supreme Court review Federal Circuit decision in Sandoz v. Amgen” that appears in the January 2017 online edition of DDNEWS. Last summer, the Federal Circuit decided two questions under Biologics Price Control and Innovation Act (BPCIA) in Amgen v. Sandoz. The first was whether the law required a biosimilar applicant (BA) to disclose its biosimilar application (aBLA) and other information to the reference product sponsor (RPS), with the court deciding disclosure is not mandatory. The second question was whether the 180-day notice provisions of the statute permits a BA to give notice prior to FDA approval of the aBLA; according to the Federal Circuit’s decision, the BA cannot provide such “early” notice. Both parties petitioned for Supreme Court review, and the court asked the Solicitor General (SG) for the government’s views on whether or not to grant these petitions. Last week, tha nation’s acting solicitor general, Ian Heath Gershengorn, provided those views. view the article