Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant
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Issuing agencies
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 133 (Thursday, July 11, 2024)</title>
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[Federal Register Volume 89, Number 133 (Thursday, July 11, 2024)]
[Notices]
[Page 56885]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#632e1610170205024d360d0f16230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="c38eb6b0b7a2a5a2ed96adafb683a5a7a2edababb0eda4acb5">[email protected]</span></a>.
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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