80 FR 29723 - Determination of Regulatory Review Period for Purposes of Patent Extension; STIVARGA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		29723-29724
FR Document		2015-12577

The Food and Drug Administration (FDA) has determined the regulatory review period for STIVARGA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29723-29724]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-12577]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0307]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for STIVARGA 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 the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug 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, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., Rm. 3180, Silver Spring, MD 20993, 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug 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
drug 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 drug product STIVARGA
(regorafenib). STIVARGA is indicated for treatment of patients with
metastatic colorectal cancer who have been previously treated with
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an
anti-VEGF therapy, and if KRAS wild type, an anti-EGRF therapy.
Subsequent to this approval, the USPTO received a patent term
restoration application for STIVARGA (U.S. Patent No. 7,351,834) from
Bayer HealthCare LLC, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 23, 2014, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of STIVARGA 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
STIVARGA is 2,234 days. Of this time, 2,080 days occurred during the
testing phase of the regulatory review period, while 154 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: August 18, 2006. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on August 18, 2006.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 27,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for STIVARGA (NDA 203085) was submitted on April 27,
2012.
3. The date the application was approved: September 27, 2012. FDA
has verified the applicant's claim that NDA 203085 was approved on
September 27, 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 898 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

[[Page 29724]]

regarding whether the applicant for 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.

Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12577 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29723

The Committee shall consist of a core law. FDA has made the determination colorectal cancer who have been
of 12 voting members including the because of the submission of an previously treated with
Chair. Members and the Chair are application to the Director of the U.S. fluoropyrimidine-, oxaliplatin- and
selected by the Commissioner or Patent and Trademark Office (USPTO), irinotecan-based chemotherapy, an anti-
designee from among authorities Department of Commerce, for the VEGF therapy, and if KRAS wild type,
knowledgeable in the fields of nuclear extension of a patent which claims that an anti-EGRF therapy. Subsequent to
medicine, radiology, epidemiology or human drug product. this approval, the USPTO received a
statistics, and related specialties. ADDRESSES: Submit electronic patent term restoration application for
Members will be invited to serve for comments to http:// STIVARGA (U.S. Patent No. 7,351,834)
overlapping terms of up to 4 years. www.regulations.gov. Submit written from Bayer HealthCare LLC, and the
Almost all non-Federal members of this petitions (two copies are required) and USPTO requested FDA’s assistance in
committee serve as Special Government written comments to the Division of determining this patent’s eligibility for
Employees. The core of voting members Dockets Management (HFA–305), Food patent term restoration. In a letter dated
may include one technically qualified and Drug Administration, 5630 Fishers May 23, 2014, FDA advised the USPTO
member, selected by the Commissioner Lane, Rm. 1061, Rockville, MD 20852. that this human drug product had
or designee, who is identified with Submit petitions electronically to undergone a regulatory review period
consumer interests and is recommended http://www.regulations.gov at Docket and that the approval of STIVARGA
by either a consortium of consumer- No. FDA–2013–S–0610. represented the first permitted
oriented organizations or other FOR FURTHER INFORMATION CONTACT:
commercial marketing or use of the
interested persons. In addition to the Beverly Friedman, Office of product. Thereafter, the USPTO
voting members, the Committee may Management, Food and Drug requested that FDA determine the
include one non-voting member who is product’s regulatory review period.
Administration, 10001 New Hampshire
identified with industry interests. FDA has determined that the
Ave., Hillandale Bldg., Rm. 3180, Silver
Further information regarding the applicable regulatory review period for
Spring, MD 20993, 301–796–7900. STIVARGA is 2,234 days. Of this time,
most recent charter and other SUPPLEMENTARY INFORMATION: The Drug
information can be found at http://www. 2,080 days occurred during the testing
Price Competition and Patent Term phase of the regulatory review period,
fda.gov/AdvisoryCommittees/ Restoration Act of 1984 (Pub. L. 98–417)
CommitteesMeetingMaterials/Drugs/ while 154 days occurred during the
and the Generic Animal Drug and Patent approval phase. These periods of time
MedicalImagingDrugsAdvisory Term Restoration Act (Pub. L. 100–670)
Committee/default.htm or by contacting were derived from the following dates:
generally provide that a patent may be 1. The date an exemption under
the Designated Federal Officer (Please extended for a period of up to 5 years section 505(i) of the Federal Food, Drug,
see FOR FURTHER INFORMATION CONTACT). so long as the patented item (human and Cosmetic Act (the FD&C Act) (21
In light of the fact that no change has drug product, animal drug product, U.S.C. 355(i)) became effective: August
been made to the committee name or medical device, food additive, or color 18, 2006. FDA has verified the
description of duties, no amendment additive) was subject to regulatory applicant’s claim that the date the
will be made to 21 CFR 14.100. review by FDA before the item was investigational new drug application
This notice is issued under the marketed. Under these acts, a product’s became effective was on August 18,
Federal Advisory Committee Act (5 regulatory review period forms the basis 2006.
U.S.C. app.). For general information for determining the amount of extension 2. The date the application was
related to FDA advisory committees an applicant may receive. initially submitted with respect to the
please visit us at http://www.fda.gov/ A regulatory review period consists of human drug product under section
AdvisoryCommittees/default.htm. two periods of time: A testing phase and 505(b) of the FD&C Act: April 27, 2012.
Dated: May 18, 2015. an approval phase. For human drug FDA has verified the applicant’s claim
Leslie Kux, products, the testing phase begins when that the new drug application (NDA) for
Associate Commissioner for Policy. the exemption to permit the clinical STIVARGA (NDA 203085) was
[FR Doc. 2015–12401 Filed 5–21–15; 8:45 am] investigations of the drug becomes submitted on April 27, 2012.
BILLING CODE 4164–01–P
effective and runs until the approval 3. The date the application was
phase begins. The approval phase starts approved: September 27, 2012. FDA has
with the initial submission of an verified the applicant’s claim that NDA
DEPARTMENT OF HEALTH AND application to market the human drug 203085 was approved on September 27,
HUMAN SERVICES product and continues until FDA grants 2012.
permission to market the drug product. This determination of the regulatory
Food and Drug Administration Although only a portion of a regulatory review period establishes the maximum
review period may count toward the potential length of a patent extension.
[Docket No. FDA–2014–E–0307]
actual amount of extension that the However, the USPTO applies several
Determination of Regulatory Review Director of USPTO may award (for statutory limitations in its calculations
Period for Purposes of Patent example, half the testing phase must be of the actual period for patent extension.
Extension; STIVARGA subtracted as well as any time that may In its application for patent extension,
have occurred before the patent was this applicant seeks 898 days of patent
Food and Drug Administration, issued), FDA’s determination of the term extension.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

AGENCY:
HHS. length of a regulatory review period for Anyone with knowledge that any of
ACTION: Notice. a human drug product will include all the dates as published are incorrect may
of the testing phase and approval phase submit to the Division of Dockets
SUMMARY: The Food and Drug as specified in 35 U.S.C. 156(g)(1)(B). Management (see ADDRESSES) either
Administration (FDA) has determined FDA has approved for marketing the electronic or written comments and ask
the regulatory review period for human drug product STIVARGA for a redetermination by July 21, 2015.
STIVARGA and is publishing this notice (regorafenib). STIVARGA is indicated Furthermore, any interested person may
of that determination as required by for treatment of patients with metastatic petition FDA for a determination

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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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Document Created: 2015-12-15 15:44:43
Document Modified: 2015-12-15 15:44:43

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, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation		80 FR 29723

80 FR 29723 - Determination of Regulatory Review Period for Purposes of Patent Extension; STIVARGA

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