80 FR 25300 - Determination of Regulatory Review Period for Purposes of Patent Extension; NESINA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		25300-25301
FR Document		2015-10337

The Food and Drug Administration (FDA) has determined the regulatory review period for NESINA 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 25300-25301]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-10337]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0154]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NESINA 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

[[Page 25301]]

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 NESINA
(alogliptin benzoate). NESINA 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 NESINA (U.S. Patent No. 8,173,663) from
Takeda Pharmaceuticals U.S.A., and the USPTO requested FDA's assistance
in determining this 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 NESINA 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
NESINA is 3,021 days. Of this time, 1,164 days occurred during the
testing phase of the regulatory review period, while 1,857 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: October 20, 2004. The applicant claims October 19, 2004, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was October 20, 2004, 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: December
27, 2007. FDA has verified the applicant's claim that the new drug
application (NDA) for NESINA (NDA 22-271) was submitted on December 27,
2007.
3. The date the application was approved: January 25, 2013. FDA has
verified the applicant's claim that NDA 22-271 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 264 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. 2015-10337 Filed 5-1-15; 8:45 am]
BILLING CODE 4164-01-P

25300 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices

investigation of the device and runs 2. The date an application was DEPARTMENT OF HEALTH AND
until the approval phase begins. The initially submitted with respect to the HUMAN SERVICES
approval phase starts with the initial device under section 515 of the FD&C
submission of an application to market Act (21 U.S.C. 360e): December 23, Food and Drug Administration
the device and continues until 2011. FDA has verified the applicant’s [Docket No. FDA–2014–E–0154]
permission to market the device is claim that the premarket approval
granted. Although only a portion of a application (PMA) for CAMERON Determination of Regulatory Review
regulatory review period may count HEALTH S–ICD SYSTEM (PMA Period for Purposes of Patent
toward the actual amount of extension P110042) was initially submitted Extension; NESINA
that the Director of USPTO may award December 23, 2011.
(half the testing phase must be AGENCY: Food and Drug Administration,
3. The date the application was HHS.
subtracted as well as any time that may
approved: September 28, 2012. FDA has ACTION: Notice.
have occurred before the patent was
verified the applicant’s claim that PMA
issued), FDA’s determination of the
length of a regulatory review period for P110042 was approved on September SUMMARY: The Food and Drug
a medical device will include all of the 28, 2012. Administration (FDA) has determined
testing phase and approval phase as This determination of the regulatory the regulatory review period for
specified in 35 U.S.C. 156(g)(3)(B). review period establishes the maximum NESINA and is publishing this notice of
FDA has approved for marketing the potential length of a patent extension. that determination as required by law.
medical device CAMERON HEALTH However, the USPTO applies several FDA has made the determination
S–ICD SYSTEM. CAMERON HEALTH statutory limitations in its calculations because of the submission of an
S–ICD SYSTEM is indicated to provide of the actual period for patent extension. application to the Director of the U.S.
defibrillation therapy for the treatment In its applications for patent extension, Patent and Trademark Office (USPTO),
of life-threatening ventricular this applicant seeks 651 days of patent Department of Commerce, for the
tachyarrhythmias in patients who do term extension. extension of a patent which claims that
not have symptomatic bradycardia, human drug product.
Anyone with knowledge that any of
incessant ventricular tachycardia, or ADDRESSES: Submit electronic
the dates as published are incorrect may comments to http://
spontaneous, frequently recurring submit to the Division of Dockets
ventricular tachycardia that is reliably www.regulations.gov. Submit written
Management (see ADDRESSES) either petitions (two copies are required) and
terminated with antitachycardia pacing. electronic or written comments and ask
Subsequent to this approval, the USPTO written comments to the Division of
for a redetermination by July 6, 2015. Dockets Management (HFA–305), Food
received patent term restoration Furthermore, any interested person may
applications for CAMERON HEALTH S– and Drug Administration, 5630 Fishers
petition FDA for a determination Lane, Rm. 1061, Rockville, MD 20852.
ICD SYSTEM (U.S. Patent Nos.
regarding whether the applicant for Submit petitions electronically to
6,856,835 and 7,149,575) from Cameron
extension acted with due diligence http://www.regulations.gov at Docket
Health Inc., and the USPTO requested
during the regulatory review period by No. FDA–2013–S–0610.
FDA’s assistance in determining the
November 2, 2015. To meet its burden, FOR FURTHER INFORMATION CONTACT:
patents’ eligibility for patent term
restoration. In a letter dated March 18, the petition must contain sufficient facts Beverly Friedman, Office of
2014, FDA advised the USPTO that this to merit an FDA investigation. (See H. Management, Food and Drug
medical device had undergone a Rept. 857, part 1, 98th Cong., 2d sess., Administration, 10001 New Hampshire
regulatory review period and that the pp. 41–42, 1984.) Petitions should be in Ave., Hillandale Bldg., Rm. 3180, Silver
approval of CAMERON HEALTH S–ICD the format specified in 21 CFR 10.30. Spring, MD 20993, 301–796–7900.
SYSTEM represented the first permitted Interested persons may submit to the SUPPLEMENTARY INFORMATION: The Drug
commercial marketing or use of the Division of Dockets Management (see Price Competition and Patent Term
product. Thereafter, the USPTO ADDRESSES) electronic or written Restoration Act of 1984 (Pub. L. 98–417)
requested that the FDA determine the comments and written or electronic and the Generic Animal Drug and Patent
product’s regulatory review period. petitions. It is only necessary to send Term Restoration Act (Pub. L. 100–670)
FDA has determined that the one set of comments. Identify comments generally provide that a patent may be
applicable regulatory review period for with the docket number found in extended for a period of up to 5 years
CAMERON HEALTH S–ICD SYSTEM is brackets in the heading of this so long as the patented item (human
1,024 days. Of this time, 743 days document. If you submit a written drug product, animal drug product,
occurred during the testing phase of the petition, two copies are required. A medical device, food additive, or color
regulatory review period, while 281 petition submitted electronically must additive) was subject to regulatory
days occurred during the approval be submitted to http:// review by FDA before the item was
phase. These periods of time were www.regulations.gov, Docket No. FDA– marketed. Under these acts, a product’s
derived from the following dates: 2013–S–0610. Comments and petitions regulatory review period forms the basis
1. The date an exemption under that have not been made publicly for determining the amount of extension
section 520(g) of the Federal Food, Drug, available on http://www.regulations.gov an applicant may receive.
and Cosmetic Act (the FD&C Act) (21 may be viewed in the Division of A regulatory review period consists of
mstockstill on DSK4VPTVN1PROD with NOTICES

U.S.C. 360j(g)) involving this device Dockets Management between 9 a.m. two periods of time: A testing phase and
became effective: December 11, 2009. and 4 p.m., Monday through Friday. an approval phase. For human drug
FDA has verified the applicant’s claim Dated: April 28, 2015. products, the testing phase begins when
that the date the investigational device the exemption to permit the clinical
Leslie Kux,
exemption (IDE) required under section investigations of the drug becomes
520(g) of the FD&C act for human tests Associate Commissioner for Policy. effective and runs until the approval
to begin became effective December 11, [FR Doc. 2015–10334 Filed 5–1–15; 8:45 am] phase begins. The approval phase starts
2009. BILLING CODE 4164–01–P with the initial submission of an

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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25301

application to market the human drug This determination of the regulatory the regulatory review period for
product and continues until FDA grants review period establishes the maximum BOSULIF and is publishing this notice
permission to market the drug product. potential length of a patent extension. of that determination as required by
Although only a portion of a regulatory However, the USPTO applies several law. FDA has made the determination
review period may count toward the statutory limitations in its calculations because of the submission of an
actual amount of extension that the of the actual period for patent extension. application to the Director of the U.S.
Director of USPTO may award (for In its application for patent extension, Patent and Trademark Office (USPTO),
example, half the testing phase must be this applicant seeks 264 days of patent Department of Commerce, for the
subtracted as well as any time that may term extension. extension of a patent which claims that
have occurred before the patent was Anyone with knowledge that any of human drug product.
issued), FDA’s determination of the the dates as published are incorrect may ADDRESSES: Submit electronic
length of a regulatory review period for submit to the Division of Dockets comments to http://
a human drug product will include all Management (see ADDRESSES) either www.regulations.gov. Submit written
of the testing phase and approval phase electronic or written comments and ask petitions (two copies are required) and
as specified in 35 U.S.C. 156(g)(1)(B). for a redetermination by July 6, 2015. written comments to the Division of
FDA has approved for marketing the Furthermore, any interested person may Dockets Management (HFA–305), Food
human drug product NESINA petition FDA for a determination and Drug Administration, 5630 Fishers
(alogliptin benzoate). NESINA is regarding whether the applicant for Lane, rm. 1061, Rockville, MD 20852.
indicated as an adjunct to diet and extension acted with due diligence Submit petitions electronically to http://
exercise to improve glycemic control in during the regulatory review period by www.regulations.gov at Docket No.
adults with type 2 diabetes mellitus. November 2, 2015. To meet its burden, FDA–2013–S–0610.
Subsequent to this approval, the USPTO the petition must contain sufficient facts FOR FURTHER INFORMATION CONTACT:
received a patent term restoration to merit an FDA investigation. (See H. Beverly Friedman, Office of
application for NESINA (U.S. Patent No. Rept. 857, part 1, 98th Cong., 2d sess., Management, Food and Drug
8,173,663) from Takeda Pharmaceuticals pp. 41–42, 1984.) Petitions should be in Administration, 10001 New Hampshire
U.S.A., and the USPTO requested FDA’s the format specified in 21 CFR 10.30. Ave., Hillandale Campus, Rm. 3180,
assistance in determining this patent’s Interested persons may submit to the Silver Spring, MD 20993, 301–796–
eligibility for patent term restoration. In Division of Dockets Management (see 7900.
a letter dated May 2, 2014, FDA advised ADDRESSES) electronic or written
the USPTO that this human drug SUPPLEMENTARY INFORMATION: The Drug
comments and written or electronic Price Competition and Patent Term
product had undergone a regulatory petitions. It is only necessary to send
review period and that the approval of Restoration Act of 1984 (Pub. L. 98–417)
one set of comments. Identify comments and the Generic Animal Drug and Patent
NESINA 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– additive) was subject to regulatory
NESINA is 3,021 days. Of this time,
2013–S–0610. Comments and petitions review by FDA before the item was
1,164 days occurred during the testing
that have not been made publicly marketed. Under these acts, a product’s
phase of the regulatory review period,
while 1,857 days occurred during the available on http://www.regulations.gov regulatory review period forms the basis
approval phase. These periods of time may be viewed in the Division of for determining the amount of extension
were derived from the following dates: Dockets Management between 9 a.m. an applicant may receive.
1. The date an exemption under and 4 p.m., Monday through Friday. 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: October Associate Commissioner for Policy. products, the testing phase begins when
20, 2004. The applicant claims October [FR Doc. 2015–10337 Filed 5–1–15; 8:45 am]
the exemption to permit the clinical
19, 2004, as the date the investigational investigations of the drug becomes
BILLING CODE 4164–01–P
new drug application (IND) became effective and runs until the approval
effective. However, FDA records phase begins. The approval phase starts
indicate that the IND effective date was DEPARTMENT OF HEALTH AND with the initial submission of an
October 20, 2004, which was 30 days HUMAN SERVICES application to market the human drug
after FDA receipt of 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–0074] review period may count toward the
human drug product under section
505(b) of the FD&C Act: December 27, actual amount of extension that the
Determination of Regulatory Review
2007. FDA has verified the applicant’s Director of USPTO may award (for
Period for Purposes of Patent
mstockstill on DSK4VPTVN1PROD with NOTICES

claim that the new drug application example, half the testing phase must be
Extension; BOSULIF
(NDA) for NESINA (NDA 22–271) was subtracted as well as any time that may
submitted on December 27, 2007. 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: January 25, 2013. 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
22–271 was approved on January 25, SUMMARY: The Food and Drug of the testing phase and approval phase
2013. Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B).

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Document Created: 2018-02-21 10:22:59
Document Modified: 2018-02-21 10:22:59

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 25300

80 FR 25300 - Determination of Regulatory Review Period for Purposes of Patent Extension; NESINA

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