Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant, 14171 [2023-04583]
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Federal Register / Vol. 88, No. 44 / Tuesday, March 7, 2023 / Notices
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ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:49 Mar 06, 2023
Jkt 259001
Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04562 Filed 3–6–23; 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 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:
Sandra Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132,
Silver Spring, MD 20993–0002, 301–
796–1042, Sandra.Benton@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
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
SUMMARY:
PO 00000
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Fmt 4703
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14171
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. Mylan
Pharmaceuticals Inc., 1:22–CV–61
(N.D.W. Va., filed August 2, 2022).
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: February 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04583 Filed 3–6–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0680]
Fosun Pharma USA Inc.; Withdrawal of
Approval of Abbreviated New Drug
Application for Pemoline Tablets, 18.75
Milligrams, 37.5 Milligrams, and 75
Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of abbreviated
new drug application (ANDA) 075286
for pemoline tablets, 18.75 milligrams
(mg), 37.5 mg, and 75 mg, held by Fosun
Pharma USA Inc. (Fosun), 104 Carnegie
Center, Princeton, NJ 08540. Fosun
requested that approval of this
application be withdrawn and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of
March 7, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
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07MRN1
]]>Agencies
[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Page 14171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04583]
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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.
-----------------------------------------------------------------------
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 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: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993-0002, 301-
796-1042, [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. Mylan
Pharmaceuticals Inc., 1:22-CV-61 (N.D.W. Va., filed August 2, 2022).
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: February 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04583 Filed 3-6-23; 8:45 am]
BILLING CODE 4164-01-P
