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# Amgen v. Apotex Biosimilar Patent Infringement Action
- URL: https://www.fdaweb.com/amgen-v-apotex-biosimilar-patent-infringement-action/
- Published: 2016-04-01T12:00:00.000Z
- Updated: 2026-09-14T20:52:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135254

*Federal Register* Notice: FDA is publishing 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 BLA. The agency has received notice of the following complaint: Amgen, Inc., v. Apotex, Inc., 15-cv-61631 (consolidated with 15-cv-62081, S.D. FL., filed 10/2/15). Under the Public Health Service Act, an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act and FDA is required to publish notice of the complaint in the *Federal Register*. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-01/pdf/2016-07364.pdf?ref=fdaweb.com)