Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant

---
identifier: "/us/fr/2015-20780"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant"
title_number: 0
title_name: "Federal Register"
section_number: "2015-20780"
section_name: "Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant"
positive_law: false
currency: "2015-08-24"
last_updated: "2015-08-24"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2015-20780"
document_type: "notice"
publication_date: "2015-08-24"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "80 FR 51277"
fr_volume: 80
docket_ids:
  - "Docket No. FDA-2015-N-2489"
fr_action: "Notice."
---


#  Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant

**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:**

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:

*Janssen Biotech, Inc., et. al.* v. *Celltrion Healthcare Co., Ltd., et al.,* 15-cv-10698 (D. Mass., filed March 6, 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: August 17, 2015.

Leslie Kux,

Associate Commissioner for Policy.