On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.

Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application.  Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

SupremeCourt_103670531Regular readers of our blog know that we’ve been following developments related to biosimilar products for some time (see our past coverage here).  On April 26, 2017, the U.S. Supreme Court heard oral argument in its first case involving the Biologics Price Competition and Innovation Act (“BPCIA”), Amgen v. Sandoz.  Our Intellectual Property colleague Thomas Wintner attended the Court’s oral argument (in the “good seats,” no less, as a member of the Supreme Court bar) and prepared a client alert that recaps the argument.  The full client alert is available here.  Stay tuned for further analysis and updates on this important biosimilar case and other developments in the field.

The U.S. Supreme Court is expected to issue its landmark decision on the constitutionality of the Affordable Care Act at any time.  Mintz Levin and ML Strategies have monitored the proceedings closely and have assembled a team (including Gary Bacher, Alden Bianchi, and Steve Weiner) to discuss the decision’s impact on the provision and financing of health care and health insurance in the United States for decades to come.  We will hold a webinar on the ruling within 48 hours of publication.  Please stay tuned for further details.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.  This week’s Update leads with oral arguments in the multi-state challenge to the Affordable Care Act, and provides links to transcripts of the arguments and questioning from the Justices, as well as to audio of the oral arguments.