Tag: aBLA

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Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court

Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court

The U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and Innovation Act (BPCIA).  The Court held:  (1) that the patent dance is not enforceable by injunction under Federal law, and  (2) that a biosimilar applicant’s 180-day “notice of commercial marketing” can be provided before FDA approval.  (See Sandoz Inc. v. Amgen Inc., Nos. 15-1039 and 15-1195, slip op. and our IP Alert Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument.)

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