[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46173-46174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19811]


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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 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 proposed biosimilar product notified FDA that a 
patent infringement action was filed in connection with the applicant's 
biologics license application (BLA). Under the Public Health Service 
Act (PHS 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. FDA is required to publish notice of the 
complaint in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Angela Hoague, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993-0002, 301-
348-3915, <a href="/cdn-cgi/l/email-protection#76171811131a17581e191711031336101217581e1e0558111900"><span class="__cf_email__" data-cfemail="67060900020b06490f080600120227010306490f0f1449000811">[email protected]</span></a>.

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

[[Page 46174]]

product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the 
BPCI Act, describes the requirements for a BLA for a proposed 
biosimilar product or a proposed interchangeable product (351(k) BLA). 
Section 351(l) of the PHS Act, also added by the BPCI Act, describes 
certain procedures for exchanging patent information and resolving 
patent disputes between a 351(k) BLA applicant and the holder of the 
BLA reference product. If a 351(k) applicant is served with a complaint 
for a patent infringement described in section 351(l)(6) of the PHS 
Act, the applicant is required to provide the FDA 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: Genentech, Inc. and City of Hope v. Amgen 
Inc., 1:18-cv-00924-GMS (D. Del., filed July 2, 2018).
    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: September 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19811 Filed 9-11-18; 8:45 am]
BILLING CODE 4164-01-P


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