81 FR 10629 - Determination of Regulatory Review Period for Purposes of Patent Extension; INVOKANA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 40 (March 1, 2016)

Page Range		10629-10630
FR Document		2016-04369

The Food and Drug Administration (FDA) has determined the regulatory review period for INVOKANA 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 81 Issue 40 (Tuesday, March 1, 2016)

[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10629-10630]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-04369]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-1234]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by May 2,
2016. 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 August 29, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-E-1234 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; INVOKANA''. Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

[[Page 10630]]

I. Background

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 INVOKANA
(canagliflozin). INVOKANA 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 INVOKANA (U.S. Patent No. 8,222,219) from
Mitsubishi Tanabe Pharma Corporation of Osaka, Japan, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated May 11, 2015, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the approval of INVOKANA represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
INVOKANA is 2,137 days. Of this time, 1,834 days occurred during the
testing phase of the regulatory review period, while 303 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 25, 2007. FDA has verified the Mitsubishi Tanabe Pharma
Corporation of Osaka, Japan claim that May 25, 2007, is the date the
investigational new drug application became effective
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 31,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for INVOKANA (NDA 204042) was initially submitted on
May 31, 2012.
3. The date the application was approved: March 29, 2013. FDA has
verified the applicant's claim that NDA 204042 was approved on March
29, 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 256 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and 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.
Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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: February 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04369 Filed 2-29-16; 8:45 am]
BILLING CODE 4164-01-P

10630 Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices

I. Background II. Determination of Regulatory Review www.regulations.gov may be viewed in
Period the Division of Dockets Management
The Drug Price Competition and between 9 a.m. and 4 p.m., Monday
Patent Term Restoration Act of 1984 FDA has determined that the
applicable regulatory review period for through Friday.
(Pub. L. 98–417) and the Generic
INVOKANA is 2,137 days. Of this time, Dated: February 24, 2016.
Animal Drug and Patent Term
1,834 days occurred during the testing Leslie Kux,
Restoration Act (Pub. L. 100–670)
phase of the regulatory review period, Associate Commissioner for Policy.
generally provide that a patent may be
while 303 days occurred during the [FR Doc. 2016–04369 Filed 2–29–16; 8:45 am]
extended for a period of up to 5 years approval phase. These periods of time BILLING CODE 4164–01–P
so long as the patented item (human were derived from the following dates:
drug product, animal drug product, 1. The date an exemption under
medical device, food additive, or color section 505(i) of the Federal Food, Drug, DEPARTMENT OF HEALTH AND
additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21 HUMAN SERVICES
review by FDA before the item was U.S.C. 355(i)) became effective: May 25,
marketed. Under these acts, a product’s 2007. FDA has verified the Mitsubishi Food and Drug Administration
regulatory review period forms the basis Tanabe Pharma Corporation of Osaka, [Docket No. FDA–2014–E–2371]
for determining the amount of extension Japan claim that May 25, 2007, is the
an applicant may receive. date the investigational new drug Determination of Regulatory Review
A regulatory review period consists of application became effective Period for Purposes of Patent
two periods of time: A testing phase and 2. The date the application was Extension; ANORO ELLIPTA
an approval phase. For human drug initially submitted with respect to the
human drug product under section AGENCY: Food and Drug Administration,
products, the testing phase begins when HHS.
the exemption to permit the clinical 505(b) of the FD&C Act: May 31, 2012.
FDA has verified the applicant’s claim ACTION: Notice.
investigations of the drug becomes
that the new drug application (NDA) for
effective and runs until the approval SUMMARY: The Food and Drug
INVOKANA (NDA 204042) was initially
phase begins. The approval phase starts submitted on May 31, 2012. Administration (FDA) has determined
with the initial submission of an 3. The date the application was the regulatory review period for ANORO
application to market the human drug approved: March 29, 2013. FDA has ELLIPTA and is publishing this notice
product and continues until FDA grants verified the applicant’s claim that NDA of that determination as required by
permission to market the drug product. 204042 was approved on March 29, law. FDA has made the determination
Although only a portion of a regulatory 2013. because of the submission of an
review period may count toward the This determination of the regulatory application to the Director of the U.S.
actual amount of extension that the review period establishes the maximum Patent and Trademark Office (USPTO),
Director of USPTO may award (for potential length of a patent extension. Department of Commerce, for the
example, half the testing phase must be However, the USPTO applies several extension of a patent which claims that
subtracted as well as any time that may statutory limitations in its calculations human drug product.
have occurred before the patent was of the actual period for patent extension. DATES: Anyone with knowledge that any
issued), FDA’s determination of the In its application for patent extension, of the dates as published (in the
length of a regulatory review period for this applicant seeks 256 days of patent SUPPLEMENTARY INFORMATION section) are
a human drug product will include all term extension. incorrect may submit either electronic
of the testing phase and approval phase or written comments and ask for a
III. Petitions redetermination by May 2, 2016.
as specified in 35 U.S.C. 156(g)(1)(B).
Anyone with knowledge that any of Furthermore, any interested person may
FDA has approved for marketing the the dates as published are incorrect may petition FDA for a determination
human drug product INVOKANA submit either electronic or written regarding whether the applicant for
(canagliflozin). INVOKANA is indicated comments and ask for a redetermination extension acted with due diligence
as an adjunct to diet and exercise to (see DATES). Furthermore, any interested during the regulatory review period by
improve glycemic control in adults with person may petition FDA for a August 29, 2016. See ‘‘Petitions’’ in the
type 2 diabetes mellitus. Subsequent to determination regarding whether the SUPPLEMENTARY INFORMATION section for
this approval, the USPTO received a applicant for extension acted with due more information.
patent term restoration application for diligence during the regulatory review ADDRESSES: You may submit comments
INVOKANA (U.S. Patent No. 8,222,219) period. To meet its burden, the petition as follows:
from Mitsubishi Tanabe Pharma must be timely (see DATES) and contain
Corporation of Osaka, Japan, and the sufficient facts to merit an FDA Electronic Submissions
USPTO requested FDA’s assistance in investigation. (See H. Rept. 857, part 1, Submit electronic comments in the
determining this patent’s eligibility for 98th Cong., 2d sess., pp. 41–42, 1984.) following way:
patent term restoration. In a letter dated Petitions should be in the format • Federal eRulemaking Portal: http://
May 11, 2015, FDA advised the USPTO specified in 21 CFR 10.30. www.regulations.gov. Follow the
Submit petitions electronically to instructions for submitting comments.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

that this human drug product had
undergone a regulatory review period http://www.regulations.gov at Docket Comments submitted electronically,
and that the approval of INVOKANA No. FDA–2013–S–0610. Submit written including attachments, to http://
represented the first permitted petitions (two copies are required) to the www.regulations.gov will be posted to
Division of Dockets Management (HFA– the docket unchanged. Because your
commercial marketing or use of the
305), Food and Drug Administration, comment will be made public, you are
product. Thereafter, the USPTO
5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your
requested that FDA determine the
MD 20852. Petitions that have not been comment does not include any
product’s regulatory review period. made publicly available on http:// confidential information that you or a

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Document Created: 2018-02-02 14:59:42
Document Modified: 2018-02-02 14:59:42

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.
Dates		Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by May 2, 2016. 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 August 29, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Contact		Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation		81 FR 10629

81 FR 10629 - Determination of Regulatory Review Period for Purposes of Patent Extension; INVOKANA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 40 (March 1, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration