82 FR 36149 - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 148 (August 3, 2017)

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.

[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36149-36150]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16380]


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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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[[Page 36150]]

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. 6246, 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 to provide 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: Amgen, Inc., et al. v. Coherus 
Biosciences, Inc., 17-cv-00546 (D. Del., filed May 10, 2017).
    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: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16380 Filed 8-2-17; 8:45 am]
BILLING CODE 4164-01-P