This PDF is the current document as it appeared on Public Inspection on 09/16/2016 at 08:45 am.
Food and Drug Administration, HHS.
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.Start Further Info
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, firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start Signature
Dated: September 12, 2016.
Associate Commissioner for Policy.
[FR Doc. 2016-22376 Filed 9-16-16; 8:45 am]
BILLING CODE 4164-01-P