80 FR 25302 - Determination of Regulatory Review Period for Purposes of Patent Extension; KAZANO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

Page Range		25302-25303
FR Document		2015-10335

The Food and Drug Administration (FDA) has determined the regulatory review period for KAZANO 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 85 (Monday, May 4, 2015)

[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25302-25303]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-10335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0156]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for KAZANO 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 Campus, 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 KAZANO
(alogliptin benzoate and metformin hydrochloride). KAZANO is indicated
as an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus. Subsequent to this approval, the
USPTO received a patent term restoration application for KAZANO (U.S.
Patent No. 8,288,539) from Takeda Pharmaceutical Company Limited, and
the USPTO requested FDA's assistance in determining this

[[Page 25303]]

patent's eligibility for patent term restoration. In a letter dated May
2, 2014, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of KAZANO
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
KAZANO is 1,365 days. Of this time, 934 days occurred during the
testing phase of the regulatory review period, while 431 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: May 3, 2009. The applicant claims May 4, 2009, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was May 3,
2009, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
22, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for KAZANO (NDA 203-414) was submitted on November
22, 2011.
3. The date the application was approved: January 25, 2013. FDA has
verified the applicant's claim that NDA 203-414 was approved on January
25, 2013.
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 102 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 6, 2015. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by November 2, 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: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10335 Filed 5-1-15; 8:45 am]
BILLING CODE 4164-01-P

25302 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices

FDA has approved for marketing the electronic or written comments and ask petitions (two copies are required) and
human drug product BOSULIF for a redetermination by July 6, 2015. written comments to the Division of
(bosutinib monohydrate). BOSULIF is Furthermore, any interested person may Dockets Management (HFA–305), Food
indicated for treatment of adult patients petition FDA for a determination and Drug Administration, 5630 Fishers
with chronic, accelerated, or blast phase regarding whether the applicant for Lane, rm. 1061, Rockville, MD 20852.
Ph+ chronic myelogenous leukemia extension acted with due diligence Submit petitions electronically to http://
with resistance or intolerance to prior during the regulatory review period by www.regulations.gov at Docket No.
therapy. Subsequent to this approval, November 2, 2015. To meet its burden, FDA–2013–S–0610.
the USPTO received a patent term the petition must contain sufficient facts FOR FURTHER INFORMATION CONTACT:
restoration application for BOSULIF to merit an FDA investigation. (See H. Beverly Friedman, Office of
(U.S. Patent No. RE42376) from Wyeth Rept. 857, part 1, 98th Cong., 2d sess., Management, Food and Drug
Holdings Corporation, and the USPTO pp. 41–42, 1984.) Petitions should be in Administration, 10001 New Hampshire
requested FDA’s assistance in the format specified in 21 CFR 10.30. Ave., Hillandale Campus, rm. 3180,
determining this patent’s eligibility for Interested persons may submit to the Silver Spring, MD 20993, 301–796–
patent term restoration. In a letter dated Division of Dockets Management (see 7900.
March 26, 2014, FDA advised the ADDRESSES) electronic or written
SUPPLEMENTARY INFORMATION: The Drug
USPTO that this human drug product comments and written or electronic Price Competition and Patent Term
had undergone a regulatory review petitions. It is only necessary to send Restoration Act of 1984 (Pub. L. 98–417)
period and that the approval of one set of comments. Identify comments and the Generic Animal Drug and Patent
BOSULIF represented the first permitted with the docket number found in
commercial marketing or use of the Term Restoration Act (Pub. L. 100–670)
brackets in the heading of this generally provide that a patent may be
product. Thereafter, the USPTO document. If you submit a written
requested that FDA determine the extended for a period of up to 5 years
petition, two copies are required. A so long as the patented item (human
product’s regulatory review period. petition submitted electronically must
FDA has determined that the drug product, animal drug product,
be submitted to http:// medical device, food additive, or color
applicable regulatory review period for www.regulations.gov, Docket No. FDA–
BOSULIF is 3,032 days. Of this time, additive) was subject to regulatory
2013–S–0610. Comments and petitions review by FDA before the item was
2,739 days occurred during the testing that have not been made publicly
phase of the regulatory review period, marketed. Under these acts, a product’s
available on http://www.regulations.gov regulatory review period forms the basis
while 293 days occurred during the may be viewed in the Division of
approval phase. These periods of time for determining the amount of extension
Dockets Management between 9 a.m. an applicant may receive.
were derived from the following dates: and 4 p.m., Monday through Friday.
1. The date an exemption under A regulatory review period consists of
section 505(i) of the Federal Food, Drug, Dated: April 28, 2015. two periods of time: A testing phase and
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, an approval phase. For human drug
U.S.C. 355(i)) became effective: May 19, Associate Commissioner for Policy. products, the testing phase begins when
2004. The applicant claims May 16, [FR Doc. 2015–10333 Filed 5–1–15; 8:45 am] the exemption to permit the clinical
2004, as the date the investigational new BILLING CODE 4164–01–P
investigations of the drug becomes
drug application (IND) became effective. effective and runs until the approval
However, FDA records indicate that the phase begins. The approval phase starts
IND effective date was May 19, 2004, DEPARTMENT OF HEALTH AND with the initial submission of an
which was 30 days after FDA receipt of HUMAN SERVICES application to market the human drug
the IND. product and continues until FDA grants
2. The date the application was Food and Drug Administration permission to market the drug product.
initially submitted with respect to the Although only a portion of a regulatory
[Docket No. FDA–2014–E–0156]
human drug product under section review period may count toward the
505(b) of the FD&C Act: November 17, Determination of Regulatory Review actual amount of extension that the
2011. FDA has verified the applicant’s Period for Purposes of Patent Director of USPTO may award (for
claim that the new drug application Extension; KAZANO example, half the testing phase must be
(NDA) for BOSULIF (NDA 203–341) was subtracted as well as any time that may
submitted on November 17, 2011. AGENCY: Food and Drug Administration, have occurred before the patent was
3. The date the application was HHS. issued), FDA’s determination of the
approved: September 4, 2012. FDA has ACTION: Notice. length of a regulatory review period for
verified the applicant’s claim that NDA a human drug product will include all
203–341 was approved on September 4, SUMMARY: The Food and Drug of the testing phase and approval phase
2012. Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B).
This determination of the regulatory the regulatory review period for FDA has approved for marketing the
review period establishes the maximum KAZANO and is publishing this notice human drug product KAZANO
potential length of a patent extension. of that determination as required by (alogliptin benzoate and metformin
However, the USPTO applies several law. FDA has made the determination hydrochloride). KAZANO is indicated
statutory limitations in its calculations because of the submission of an as an adjunct to diet and exercise to
application to the Director of the U.S.
mstockstill on DSK4VPTVN1PROD with NOTICES

of the actual period for patent extension. improve glycemic control in adults with
In its application for patent extension, Patent and Trademark Office (USPTO), type 2 diabetes mellitus. Subsequent to
this applicant seeks 1,664 days of patent Department of Commerce, for the this approval, the USPTO received a
term extension. extension of a patent which claims that patent term restoration application for
Anyone with knowledge that any of human drug product. KAZANO (U.S. Patent No. 8,288,539)
the dates as published are incorrect may ADDRESSES: Submit electronic from Takeda Pharmaceutical Company
submit to the Division of Dockets comments to http:// Limited, and the USPTO requested
Management (see ADDRESSES) either www.regulations.gov. Submit written FDA’s assistance in determining this

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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25303

patent’s eligibility for patent term Interested persons may submit to the Administration, 10001 New Hampshire
restoration. In a letter dated May 2, Division of Dockets Management (see Ave., Hillandale Campus, Rm. 3180,
2014, FDA advised the USPTO that this ADDRESSES) electronic or written Silver Spring, MD 20993, 301–796–
human drug product had undergone a comments and written or electronic 7900.
regulatory review period and that the petitions. It is only necessary to send SUPPLEMENTARY INFORMATION: The Drug
approval of KAZANO represented the one set of comments. Identify comments Price Competition and Patent Term
first permitted commercial marketing or with the docket number found in Restoration Act of 1984 (Pub. L. 98–417)
use of the product. Thereafter, the brackets in the heading of this and the Generic Animal Drug and Patent
USPTO requested that FDA determine document. If you submit a written Term Restoration Act (Pub. L. 100–670)
the product’s regulatory review period. petition, two copies are required. A generally provide that a patent may be
FDA has determined that the petition submitted electronically must extended for a period of up to 5 years
applicable regulatory review period for be submitted to http:// so long as the patented item (human
KAZANO is 1,365 days. Of this time, www.regulations.gov, Docket No. FDA– drug product, animal drug product,
934 days occurred during the testing 2013–S–0610. Comments and petitions medical device, food additive, or color
phase of the regulatory review period, that have not been made publicly additive) was subject to regulatory
while 431 days occurred during the available on http://www.regulations.gov review by FDA before the item was
approval phase. These periods of time may be viewed in the Division of marketed. Under these acts, a product’s
were derived from the following dates: Dockets Management between 9 a.m. regulatory review period forms the basis
1. The date an exemption under and 4 p.m., Monday through Friday. for determining the amount of extension
section 505(i) of the Federal Food, Drug, Dated: April 28, 2015. an applicant may receive.
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, A regulatory review period consists of
U.S.C. 355(i)) became effective: May 3, Associate Commissioner for Policy. two periods of time: A testing phase and
2009. The applicant claims May 4, 2009, an approval phase. For human drug
[FR Doc. 2015–10335 Filed 5–1–15; 8:45 am]
as the date the investigational new drug products, the testing phase begins when
BILLING CODE 4164–01–P
application (IND) became effective. the exemption to permit the clinical
However, FDA records indicate that the investigations of the drug becomes
IND effective date was May 3, 2009, effective and runs until the approval
DEPARTMENT OF HEALTH AND
which was 30 days after FDA receipt of phase begins. The approval phase starts
HUMAN SERVICES
the IND. with the initial submission of an
2. The date the application was Food and Drug Administration application to market the human drug
initially submitted with respect to the product and continues until FDA grants
human drug product under section [Docket Nos. FDA–2013–E–0476 and FDA–
2013–E–0654]
permission to market the drug product.
505(b) of the FD&C Act: November 22, Although only a portion of a regulatory
2011. FDA has verified the applicant’s Determination of Regulatory Review review period may count toward the
claim that the new drug application Period for Purposes of Patent actual amount of extension that the
(NDA) for KAZANO (NDA 203–414) Extension; TUDORZA PRESSAIR Director of USPTO may award (for
was submitted on November 22, 2011. example, half the testing phase must be
3. The date the application was AGENCY: Food and Drug Administration, subtracted as well as any time that may
approved: January 25, 2013. FDA has HHS. have occurred before the patent was
verified the applicant’s claim that NDA ACTION: Notice. issued), FDA’s determination of the
203–414 was approved on January 25, length of a regulatory review period for
2013. SUMMARY: The Food and Drug
a human drug product will include all
This determination of the regulatory Administration (FDA) has determined
of the testing phase and approval phase
review period establishes the maximum the regulatory review period for
as specified in 35 U.S.C. 156(g)(1)(B).
potential length of a patent extension. TUDORZA PRESSAIR and is publishing FDA has approved for marketing the
However, the USPTO applies several this notice of that determination as human drug product TUDORZA
statutory limitations in its calculations required by law. FDA has made the PRESSAIR (aclidinium bromide).
of the actual period for patent extension. determination because of the TUDORZA PRESSAIR is indicated for
In its application for patent extension, submission of applications to the the long-term maintenance treatment of
this applicant seeks 102 days of patent Director of the U.S. Patent and bronchospasm associated with chronic
term extension. Trademark Office (USPTO), Department obstructive pulmonary disease,
Anyone with knowledge that any of of Commerce, for the extension of a including chronic bronchitis and
the dates as published are incorrect may patent which claims that human drug emphysema. Subsequent to this
submit to the Division of Dockets product. approval, the USPTO received patent
Management (see ADDRESSES) either ADDRESSES: Submit electronic term restoration applications for
electronic or written comments and ask comments to http:// TUDORZA PRESSAIR (U.S. Patent Nos.
for a redetermination by July 6, 2015. www.regulations.gov. Submit written 6,750,226 and 7,078,412) from Almiral,
Furthermore, any interested person may petitions (two copies are required) and S.A., and the USPTO requested FDA’s
petition FDA for a determination written comments to the Division of assistance in determining the patents
regarding whether the applicant for Dockets Management (HFA–305), Food eligibilities for patent term restoration.
and Drug Administration, 5630 Fishers
mstockstill on DSK4VPTVN1PROD with NOTICES

extension acted with due diligence In a letter dated July 16, 2013, FDA
during the regulatory review period by Lane, rm. 1061, Rockville, MD 20852. advised the USPTO that this human
November 2, 2015. To meet its burden, Submit petitions electronically to http:// drug product had undergone a
the petition must contain sufficient facts www.regulations.gov at Docket No. regulatory review period and that the
to merit an FDA investigation. (See H. FDA–2013–S–0610. approval of TUDORZA PRESSAIR
Rept. 857, part 1, 98th Cong., 2d sess., FOR FURTHER INFORMATION CONTACT: represented the first permitted
pp. 41–42, 1984.) Petitions should be in Beverly Friedman, Office of commercial marketing or use of the
the format specified in 21 CFR 10.30. Management, Food and Drug product. Thereafter, the USPTO

VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1

Document Created: 2018-02-21 10:22:33
Document Modified: 2018-02-21 10:22:33

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 Campus, rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation		80 FR 25302

80 FR 25302 - Determination of Regulatory Review Period for Purposes of Patent Extension; KAZANO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration