[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Page 7844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02799]


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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 (42 U.S.C. 262(l)) 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 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: AbbVie Inc. and AbbVie Biotechnology Ltd. 
v. Alvotech HF, 1:21-cv-02258 (N.D. Ill., filed April 27, 2021).
    FDA has only a ministerial role in 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 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02799 Filed 2-9-22; 8:45 am]
BILLING CODE 4164-01-P


