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Briefing Completed in Supreme Court’s First Biosimilar Case

As we previously reported in this post, the Supreme Court granted certiorari in its first biosimilar case on Sandoz’s petition in Sandoz, Inc. v. Amgen, Inc., et al., Case No. 2015-1039 and on Amgen’s cross-petition in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195.  On January 25, 2017, the Supreme Court issued a briefing schedule and briefing for the consolidated cases is now completed.

Sandoz filed its opening brief on the merits in 15-1039 on February 10, 2017, and several industry organizations, trade associations, and pharmaceutical companies filed amici curiae briefs in support of Sandoz on February 17, 2017, including: Adello Biologics LLC; Apotex Inc. and Apotex Corp.; Coherus Biosciences, Inc.; Mylan, Inc.; AARP and AARP Foundation; Citizens Against Government Waste, The UAW Retiree Medical Benefits Trust, The National Health Law Program, and The Coalition to Protect Patient Choice; America’s Health Insurance Plans; The Biosimilars Council; Pharmaceutical Care Management Association, National Association of Chain Drug Stores, and Healthcare Supply Chain Association. The Solicitor General filed an amicus brief on behalf of the United States in support of Sandoz and also filed a motion seeking leave to participate in the oral argument.

Amgen filed its consolidated opening brief on the merits in case 15-1195 and responsive brief on the merits in 15-1039 on March 17, 2017.  AbbeVie Inc., Janssen Biotech, Inc., The Biotechnology Innovation Association, Eleven Professors (who teach and write on patent law and policy), and Genentech, Inc. each filed an amici brief in support of Amgen.

Sandoz filed its consolidated response in 15-1195 and reply in case 15-1039 on March 31, 2017.  Today, Amgen submitted its reply brief in 15-1195 to complete all of the briefing in the case. Oral argument is scheduled for Wednesday, April 26, 2017.