[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Page 14171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04583]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Receipt of Notice That a Patent Infringement Complaint Was Filed 
Against a Biosimilar or Interchangeable Biosimilar Applicant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 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: Sandra Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993-0002, 301-
796-1042, [email protected].

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. Mylan 
Pharmaceuticals Inc., 1:22-CV-61 (N.D.W. Va., filed August 2, 2022).
    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: February 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04583 Filed 3-6-23; 8:45 am]
BILLING CODE 4164-01-P


