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# Janssen Biosimilar Patent Infringement Complaint Filed
- URL: https://www.fdaweb.com/janssen-biosimilar-patent-infringement-complaint-filed/
- Published: 2017-11-20T12:00:00.000Z
- Updated: 2026-09-14T23:02:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140164

*Federal Register* notice: FDA has acknowledged 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 (BLA). The notice indicates that Janssen Biotech has filed suit against Celltrion Healthcare (17–CV–11008 in Massachusetts federal court on 5/31). FDA has a ministerial role in publishing notice of a complaint received under section 351(l)(6)(C) of the Public Health Service Act, and does not perform a substantive review of the complaint. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-20/pdf/2017-25070.pdf?ref=fdaweb.com).