Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant, 56885 [2024-15237]

Download as PDF Federal Register / Vol. 89, No. 133 / Thursday, July 11, 2024 / Notices restoration application for SPEVIGO (U.S. Patent No. 9,023,995) from Boehringer Ingelheim International GmbH, and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated January 18, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SPEVIGO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. khammond on DSKJM1Z7X2PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for SPEVIGO is 1,729 days. Of this time, 1,393 days occurred during the testing phase of the regulatory review period, while 336 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: December 9, 2017. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on December 9, 2017. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): October 1, 2021. FDA has verified the applicant’s claim that the biologics license application (BLA) for SPEVIGO (BLA 761244) was initially submitted on October 1, 2021. 3. The date the application was approved: September 1, 2022. FDA has verified the applicant’s claim that BLA 761244 was approved on September 1, 2022. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,033 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence VerDate Sep<11>2014 19:08 Jul 10, 2024 Jkt 262001 during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: July 8, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–15239 Filed 7–10–24; 8:45 am] BILLING CODE 4164–01–P 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 or Interchangeable Biosimilar Applicant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a ‘‘subsection (k) applicant’’) notified FDA that an action for patent infringement was filed in connection with the applicant’s BLA. Under the PHS Act, within 30 days after the subsection (k) applicant is served with a complaint in an action for patent infringement described under the PHS Act, the subsection (k) applicant shall provide the Secretary of Health and Human Services (HHS) with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register. FOR FURTHER INFORMATION CONTACT: Mustafa Ünlü, Center for Drug Evaluation and Research, Food and SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 9990 56885 Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1139, Silver Spring, MD 20993, 301–796– 3396, Mustafa.Unlu@fda.hhs.gov. 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)) sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. Section 351(l) of the PHS Act describes certain procedures for exchanging patent information and resolving patent disputes between a subsection (k) applicant and the holder of the BLA reference product. If a subsection (k) applicant is served with a complaint in an action for a patent infringement described in section 351(l)(6) of the PHS Act, the subsection (k) applicant is required to provide the Secretary of HHS 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: Regeneron Pharmaceuticals, Inc. v. Amgen Inc., 2:24–CV–00264 (C.D. Cal., filed January 10, 2024). FDA has only a ministerial role that is limited to 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. SUPPLEMENTARY INFORMATION: Dated: July 8, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–15237 Filed 7–10–24; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\11JYN1.SGM 11JYN1

Agencies

[Federal Register Volume 89, Number 133 (Thursday, July 11, 2024)]
[Notices]
[Page 56885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15237]


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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 or Interchangeable 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 biologics license application (BLA) for a 
biosimilar or interchangeable biosimilar product submitted under the 
Public Health Service Act (PHS Act) (a ``subsection (k) applicant'') 
notified FDA that an action for patent infringement was filed in 
connection with the applicant's BLA. Under the PHS Act, within 30 days 
after the subsection (k) applicant is served with a complaint in an 
action for patent infringement described under the PHS Act, the 
subsection (k) applicant shall provide the Secretary of Health and 
Human Services (HHS) with notice and copy of such complaint. FDA is 
required to publish notice of the complaint in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Mustafa [Uuml]nl[uuml], Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 1139, Silver Spring, MD 20993, 301-796-
3396, [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)) sets forth the 
requirements for an application for a proposed biosimilar product and 
an application or a supplement for a proposed interchangeable product.
    Section 351(l) of the PHS Act describes certain procedures for 
exchanging patent information and resolving patent disputes between a 
subsection (k) applicant and the holder of the BLA reference product. 
If a subsection (k) applicant is served with a complaint in an action 
for a patent infringement described in section 351(l)(6) of the PHS 
Act, the subsection (k) applicant is required to provide the Secretary 
of HHS 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: Regeneron Pharmaceuticals, Inc. v. Amgen 
Inc., 2:24-CV-00264 (C.D. Cal., filed January 10, 2024).
    FDA has only a ministerial role that is limited to 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 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15237 Filed 7-10-24; 8:45 am]
BILLING CODE 4164-01-P
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