83 FR 46173 - 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 83, Issue 177 (September 12, 2018)

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 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46173-46174]
From the Federal Register Online  [www.thefederalregister.org]
[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, [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

[[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