2024-15237. Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2017-N-4853]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a “subsection (k) applicant”) notified FDA that an action for patent infringement was filed in connection with the applicant's BLA. Under the PHS Act, within 30 days after the subsection (k) applicant is served with a complaint in an action for patent infringement described under the PHS Act, the subsection (k) applicant shall provide the Secretary of Health and Human Services (HHS) with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register .

FOR FURTHER INFORMATION CONTACT:

Mustafa Ünlü, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1139, Silver Spring, MD 20993, 301-796-3396, [e-mail].

SUPPLEMENTARY INFORMATION:

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010. The BPCI Act amended the PHS Act and created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)) sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product.

Section 351(l) of the PHS Act describes certain procedures for exchanging patent information and resolving patent disputes between a subsection (k) applicant and the holder of the BLA reference product. If a subsection (k) applicant is served with a complaint in an action for a patent infringement described in section 351(l)(6) of the PHS Act, the subsection (k) applicant is required to provide the Secretary of HHS with notice and a copy of the complaint within 30 days of service. FDA is required to publish notice of a complaint received under section 351(l)(6)(C) of the PHS Act in the Federal Register .

FDA received notice of the following complaint under section 351(l)(6)(C) of the PHS Act: Regeneron Pharmaceuticals, Inc. v. Amgen Inc., 2:24-CV-00264 (C.D. Cal., filed January 10, 2024).

FDA has only a ministerial role that is limited to publishing notice of a complaint received under section 351(l)(6)(C) of the PHS Act and does not perform a substantive review of the complaint.

Dated: July 8, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.