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# Notice on Biosimilar Patent Dispute in Amgen v. Sandoz
- URL: https://www.fdaweb.com/notice-on-biosimilar-patent-dispute-in-amgen-v-sandoz/
- Published: 2016-09-19T12:00:00.000Z
- Updated: 2026-09-14T21:33:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136842

*Federal Register* Notice: FDA is publishing a notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s biologics license application. Under the Public Health Service Act, a biosimilar applicant must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action, and the agency is required to publish this notice in the *Federal Registe*r. The notice received references *Amgen v. Sandoz*, (Norther California District Court, filed 5/12/2016). To view this notice , click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-19/pdf/2016-22376.pdf?ref=fdaweb.com).