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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2017-N-4853]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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,                         *angela.hoague@fda.hhs.gov*.                    

# 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                           ( print 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]

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