[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Page 64180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22376]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2489]
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: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-0979,
[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)), 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, under section 351(l)(6)(C) of the PHS Act,
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 has received notice of the following complaint under section
351(l)(6)(C) of the PHS Act: Amgen v. Sandoz, 3:16-cv-02581 (N.D. Cal.,
filed May 12, 2015).
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 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22376 Filed 9-16-16; 8:45 am]
BILLING CODE 4164-01-P