High Court's Superficial Analysis In Biosimilars Ruling

By Peg Brivanlou, Gary Messplay and Abby Parsons (June 15, 2017, 4:43 PM EDT) -- In the last 12 months, including the U.S. Supreme Court's landmark pharmaceutical decision in Sandoz Inc. v. Amgen Inc., 582 U.S. ____ (June 12, 2017), the Supreme Court has reversed the Federal Circuit seven out of eight times in patent cases.[1] This term alone, the Federal Circuit was 0-6. Patent owners are working harder and harder to protect their investment in innovation, especially in the biotech arena. The Supreme Court arrived at the outcome many in the industry were expecting, given that the Federal Circuit's decision effectively extended regulatory exclusivity by six months. Nevertheless, the Supreme Court's analysis only scratched the surface, particularly with respect to the notice of commercial marketing provision. The Supreme Court's "one size fits all" notice of commercial marketing rule may leave certain biosimilar litigants in ill-fitting suits....

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