80 FR 29724 - Determination of Regulatory Review Period for Purposes of Patent Extension; FLUCELVAX

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

Page Range		29724-29725
FR Document		2015-12397

The Food and Drug Administration (FDA) has determined the regulatory review period for FLUCELVAX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Federal Register, Volume 80 Issue 99 (Friday, May 22, 2015)

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29724-29725]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-12397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0126]

Determination of Regulatory Review Period for Purposes of Patent
Extension; FLUCELVAX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for FLUCELVAX and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993-0002, 301-796-7900.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product FLUCELVAX
(A/Brisbane/10/2010 (wild type), A/California 7/2009-like virus (H1N1),
A/Victoria/361/2011 virus IVR-165(H3N2, B/Wisconsin/1/2010 (wildtype) B
Yamagata lineage)). FLUCELVAX is indicated for active immunization for
the prevention of influenza disease caused by influenza virus subtypes
A and type B contained in the vaccine. Subsequent to this approval, the
USPTO received a patent term restoration application for FLUCELVAX
(U.S. Patent No. 6,656,720) from Novartis AG, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated May 22, 2014, FDA advised the USPTO
that this human biological product had undergone a regulatory review
period and that the approval of FLUCELVAX represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.
FDA has determined that the applicable regulatory review period for
FLUCELVAX is 2,589 days. Of this time, 2,224 days occurred during the
testing phase of the regulatory review period, while 365 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: October 21,
2005. The applicant claims March 31, 2004, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 21, 2005,
which was the date the IND was removed from clinical hold.
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): November 22, 2011. The applicant claims
October 31, 2011, as the date the biologics license application (BLA)
for FLUCELVAX (BLA 125408) was initially submitted. However, FDA
records indicate that BLA 125408 was submitted on November 22, 2011.
3. The date the application was approved: November 20, 2012. FDA
has verified the applicant's claim that BLA 125408 was approved on
November 20, 2012.
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 1,773 days of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 21, 2015. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for

[[Page 29725]]

extension acted with due diligence during the regulatory review period
by November 18, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12397 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P

29724 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices

regarding whether the applicant for and Drug Administration, 5630 Fishers application for FLUCELVAX (U.S.
extension acted with due diligence Lane, Rm. 1061, Rockville, MD 20852. Patent No. 6,656,720) from Novartis AG,
during the regulatory review period by Submit petitions electronically to and the USPTO requested FDA’s
November 18, 2015. To meet its burden, http://www.regulations.gov at Docket assistance in determining this patent’s
the petition must contain sufficient facts No. FDA–2013–S–0610. eligibility for patent term restoration. In
to merit an FDA investigation. (See H. FOR FURTHER INFORMATION CONTACT: a letter dated May 22, 2014, FDA
Rept. 857, part 1, 98th Cong., 2d sess., Beverly Friedman, Office of advised the USPTO that this human
pp. 41–42, 1984.) Petitions should be in Management, Center for Drug biological product had undergone a
the format specified in 21 CFR 10.30. Evaluation and Research, Food and regulatory review period and that the
Interested persons may submit to the Drug Administration, 10001 New approval of FLUCELVAX represented
Division of Dockets Management (see Hampshire Ave., Hillandale Campus, the first permitted commercial
ADDRESSES) electronic or written Rm. 3180, Silver Spring, MD 20993– marketing or use of the product.
comments and written or electronic 0002, 301–796–7900. Thereafter, the USPTO requested that
petitions. It is only necessary to send SUPPLEMENTARY INFORMATION: The Drug
FDA determine the product’s regulatory
one set of comments. Identify comments Price Competition and Patent Term review period.
with the docket number found in FDA has determined that the
Restoration Act of 1984 (Pub. L. 98–417)
brackets in the heading of this applicable regulatory review period for
and the Generic Animal Drug and Patent
document. If you submit a written FLUCELVAX is 2,589 days. Of this time,
Term Restoration Act (Pub. L. 100–670) 2,224 days occurred during the testing
petition, two copies are required. A generally provide that a patent may be
petition submitted electronically must phase of the regulatory review period,
extended for a period of up to 5 years while 365 days occurred during the
be submitted to http:// so long as the patented item (human
www.regulations.gov, Docket No. FDA– approval phase. These periods of time
drug product, animal drug product, were derived from the following dates:
2013–S–0610. Comments and petitions medical device, food additive, or color
that have not been made publicly 1. The date an exemption under
additive) was subject to regulatory section 505(i) of the Federal Food, Drug,
available on http://www.regulations.gov review by FDA before the item was
may be viewed in the Division of and Cosmetic Act (21 U.S.C. 355(i))
marketed. Under these acts, a product’s became effective: October 21, 2005. The
Dockets Management between 9 a.m. regulatory review period forms the basis
and 4 p.m., Monday through Friday. applicant claims March 31, 2004, as the
for determining the amount of extension date the investigational new drug
Dated: May 18, 2015. an applicant may receive. application (IND) became effective.
Leslie Kux, A regulatory review period consists of However, FDA records indicate that the
Associate Commissioner for Policy. two periods of time: A testing phase and IND effective date was October 21, 2005,
[FR Doc. 2015–12577 Filed 5–21–15; 8:45 am] an approval phase. For human which was the date the IND was
BILLING CODE 4164–01–P
biological products, the testing phase removed from clinical hold.
begins when the exemption to permit 2. The date the application was
the clinical investigations of the initially submitted with respect to the
DEPARTMENT OF HEALTH AND biological becomes effective and runs human biological product under section
HUMAN SERVICES until the approval phase begins. The 351 of the Public Health Service Act (42
approval phase starts with the initial U.S.C. 262): November 22, 2011. The
Food and Drug Administration submission of an application to market applicant claims October 31, 2011, as
the human biological product and the date the biologics license
[Docket No. FDA–2014–E–0126]
continues until FDA grants permission application (BLA) for FLUCELVAX
Determination of Regulatory Review to market the biological product. (BLA 125408) was initially submitted.
Period for Purposes of Patent Although only a portion of a regulatory However, FDA records indicate that
Extension; FLUCELVAX review period may count toward the BLA 125408 was submitted on
actual amount of extension that the November 22, 2011.
AGENCY: Food and Drug Administration, Director of USPTO may award (for 3. The date the application was
HHS. example, half the testing phase must be approved: November 20, 2012. FDA has
ACTION: Notice. subtracted as well as any time that may verified the applicant’s claim that BLA
have occurred before the patent was 125408 was approved on November 20,
SUMMARY: The Food and Drug issued), FDA’s determination of the 2012.
Administration (FDA) has determined length of a regulatory review period for This determination of the regulatory
the regulatory review period for a human biological product will include review period establishes the maximum
FLUCELVAX and is publishing this all of the testing phase and approval potential length of a patent extension.
notice of that determination as required phase as specified in 35 U.S.C. However, the USPTO applies several
by law. FDA has made the 156(g)(1)(B). statutory limitations in its calculations
determination because of the FDA has approved for marketing the of the actual period for patent extension.
submission of an application to the human biologic product FLUCELVAX In its application for patent extension,
Director of U.S. Patent and Trademark (A/Brisbane/10/2010 (wild type), A/ this applicant seeks 1,773 days of patent
Office (USPTO), Department of California 7/2009-like virus (H1N1), A/ term extension.
Commerce, for the extension of a patent Victoria/361/2011 virus IVR–165(H3N2, Anyone with knowledge that any of
asabaliauskas on DSK5VPTVN1PROD with NOTICES

which claims that human biological B/Wisconsin/1/2010 (wildtype) B the dates as published are incorrect may
product. Yamagata lineage)). FLUCELVAX is submit to the Division of Dockets
ADDRESSES: Submit electronic indicated for active immunization for Management (see ADDRESSES) either
comments to http:// the prevention of influenza disease electronic or written comments and ask
www.regulations.gov. Submit written caused by influenza virus subtypes A for a redetermination by July 21, 2015.
petitions (two copies are required) and and type B contained in the vaccine. Furthermore, any interested person may
written comments to the Division of Subsequent to this approval, the USPTO petition FDA for a determination
Dockets Management (HFA–305), Food received a patent term restoration regarding whether the applicant for

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Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29725

extension acted with due diligence Name of Committee: National Cancer Date: July 22, 2015.
during the regulatory review period by Institute Special Emphasis Panel; Peptide Time: 9:00 a.m. to 2:30 p.m.
November 18, 2015. To meet its burden, Reagents for Proteomics. Agenda: To review and evaluate grant
Date: June 15, 2015. applications.
the petition must contain sufficient facts Time: 11:00 a.m. to 3:30 p.m. Place: National Cancer Institute Shady
to merit an FDA investigation. (See H. Agenda: To review and evaluate contract Grove, 9609 Medical Center Drive, Room
Rept. 857, part 1, 98th Cong., 2d sess., proposals. 2E908, Rockville, MD 20850.
pp. 41–42, 1984.) Petitions should be in Place: National Cancer Institute Shady Contact Person: Caron A. Lyman, Ph.D.,
the format specified in 21 CFR 10.30. Grove, 9609 Medical Center Drive, Room Chief, Scientific Review Officer, Research
5W030, Rockville, MD 20850, (Telephone Programs Review Branch, Division of
Interested persons may submit to the Conference Call). Extramural Activities, National Cancer
Division of Dockets Management (see Contact Person: Thomas M. Vollberg, Institute, NIH, 9609 Medical Center Drive,
ADDRESSES) electronic or written Ph.D., Scientific Review Officer, Research Room 7W126, Bethesda, MD 20892, 240–
comments and written or electronic Technology and Contract Review Branch, 276–6348, lymanc@mail.nih.gov.
petitions. It is only necessary to send Division of Extramural Activities, National
(Catalogue of Federal Domestic Assistance
one set of comments. Identify comments Cancer Institute, NIH, 9609 Medical Center
Program Nos. 93.392, Cancer Construction;
with the docket number found in Drive, Room 7W102, Rockville, MD 20850,
240–276–6341, vollbert@mail.nih.gov. 93.393, Cancer Cause and Prevention
brackets in the heading of this Research; 93.394, Cancer Detection and
document. If you submit a written Name of Committee: National Cancer Diagnosis Research; 93.395, Cancer
Institute Special Emphasis Panel; Mobile Treatment Research; 93.396, Cancer Biology
petition, two copies are required. A Health Monitoring Devices.
petition submitted electronically must Research; 93.397, Cancer Centers Support;
Date: June 16, 2015. 93.398, Cancer Research Manpower; 93.399,
be submitted to http:// Time: 1:00 p.m. to 3:00 p.m.
Cancer Control, National Institutes of Health,
www.regulations.gov, Docket No. FDA– Agenda: To review and evaluate contract
HHS)
2013–S–0610. Comments and petitions proposals.
that have not been made publicly Place: National Cancer Institute Shady Dated: May 19, 2015.
available on http://www.regulations.gov Grove, 9609 Medical Center Drive, Room Melanie J. Gray,
2E030, Rockville, MD 20850, (Telephone
may be viewed in the Division of Program Analyst, Office of Federal Advisory
Conference Call).
Dockets Management between 9 a.m. Committee Policy.
Contact Person: Thomas M. Vollberg,
and 4 p.m., Monday through Friday. Ph.D., Scientific Review Officer, Research [FR Doc. 2015–12542 Filed 5–21–15; 8:45 am]
Comments and petitions that have not Technology and Contract Review Branch, BILLING CODE 4140–01–P

been made publicly available on Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
http://www.regulations.gov may be
Drive, Room 7W102, Rockville, MD 20850, DEPARTMENT OF HEALTH AND
viewed in the Division of Dockets 240–276–6341, vollbert@mail.nih.gov.
Management between 9 a.m. and 4 p.m., HUMAN SERVICES
Name of Committee: National Cancer
Monday through Friday. Institute Special Emphasis Panel; Wound National Institutes of Health
Dated: May 18, 2015. Healing Materials.
Leslie Kux, Date: June 17, 2015. Office of the Director, National
Time: 11:00 a.m. to 1:00 p.m. Institutes of Health Notice of Meeting
Associate Commissioner for Policy. Agenda: To review and evaluate contract
[FR Doc. 2015–12397 Filed 5–21–15; 8:45 am] proposals. Pursuant to section 10(a) of the
BILLING CODE 4164–01–P Place: National Cancer Institute Shady Federal Advisory Committee Act, as
Grove, 9609 Medical Center Drive, Room amended (5 U.S.C. App.), notice is
4E030, Rockville, MD 20850, (Telephone
hereby given of a meeting of the
DEPARTMENT OF HEALTH AND Conference Call).
Contact Person: Thomas M. Vollberg, Advisory Committee to the Director,
HUMAN SERVICES Ph.D., Scientific Review Officer, Research National Institutes of Health.
Technology and Contract Review Branch, The meeting will be open to the
National Institutes of Health Division of Extramural Activities, National public, with attendance limited to space
Cancer Institute, NIH, 9609 Medical Center available. Individuals who plan to
National Cancer Institute; Notice of Drive, Room 7W102, Rockville, MD 20850,
Closed Meetings attend and need special assistance, such
240–276–6341, vollbert@mail.nih.gov. as sign language interpretation or other
Name of Committee: National Cancer reasonable accommodations, should
Pursuant to section 10(d) of the Institute Special Emphasis Panel; R13
Federal Advisory Committee Act, as notify the Contact Person listed below
Conference Grant Review.
amended (5 U.S.C. App.), notice is Date: June 23, 2015. in advance of the meeting.
hereby given of the following meetings. Time: 1:00 p.m. to 5:00 p.m. Name of Committee: Advisory Committee
Agenda: To review and evaluate grant to the Director, National Institutes of Health.
The meetings will be closed to the applications. Date: June 11–12, 2015.
public in accordance with the Place: National Cancer Institute Shady Time: June 11, 2015, 8:30 a.m. to 6:00 p.m.
provisions set forth in sections Grove, 9609 Medical Center Drive, Room Agenda: NIH Director’s Report, ACD
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 7W556, Rockville, MD 20850, (Telephone Working Group reports.
as amended. The grant applications/ Conference Call). Place: National Institutes of Health,
contract proposals and the discussions Contact Person: Bratin K. Saha, Ph.D., Building 31, 6th Floor, Conference Room
could disclose confidential trade secrets Scientific Review Officer, Program 6C6, 31 Center Drive, Bethesda, MD 20892.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

or commercial property such as Coordination and Referral Branch, Division Time: June 12, 2015, 8:00 a.m. to 2:00 p.m.
of Extramural Activities, National Cancer Agenda: NIH IC Director Reports and other
patentable material, and personal Institute, NIH, 9609 Medical Center Drive,
information concerning individuals business of the committee.
Room 7W556, Rockville, MD 20850, 240– Place: National Institutes of Health,
associated with the grant applications/ 276–6411, sahab@mail.nih.gov. Building 31, 6th Floor, Conference Room
contract proposals, the disclosure of Name of Committee: National Cancer 6C6, 31 Center Drive, Bethesda, MD 20892.
which would constitute a clearly Institute Special Emphasis Panel; Contact Person: Gretchen Wood, Staff
unwarranted invasion of personal Opportunities for Collaborative Research at Assistant, National Institutes of Health,
privacy. the NIH Clinical Center (U01). Office of the Director, One Center Drive,

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Document Created: 2015-12-15 15:46:08
Document Modified: 2015-12-15 15:46:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993-0002, 301-796-7900.
FR Citation		80 FR 29724

80 FR 29724 - Determination of Regulatory Review Period for Purposes of Patent Extension; FLUCELVAX

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration