81 FR 91938 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRULICITY

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 243 (December 19, 2016)

Page Range		91938-91939
FR Document		2016-30399

The Food and Drug Administration (FDA) has determined the regulatory review period for TRULICITY 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 biological product.

Federal Register, Volume 81 Issue 243 (Monday, December 19, 2016)

[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91938-91939]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-30399]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-3157]

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

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 TRULICITY 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 biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 17, 2017. 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 June 19,
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows: June 19, 2017

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-2015-E-3157 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TRULICITY.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://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 https://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 https://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:

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

[[Page 91939]]

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 TRULICITY
(dulaglutide). TRULICITY 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 TRULICITY (U.S. Patent No. 7,452,966) from
Eli Lilly and Company, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 15, 2015, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of TRULICITY 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
TRULICITY is 3,303 days. Of this time, 2,937 days occurred during the
testing phase of the regulatory review period, while 366 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: September
4, 2005. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on September
4, 2005.
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): September 18, 2013. The applicant claims
September 17, 2013, as the date the biologics license application (BLA)
for TRULICITY (BLA 125469) was initially submitted. However, FDA
records indicate that BLA 125469 was submitted on September 18, 2013.
3. The date the application was approved: September 18, 2014. FDA
has verified the applicant's claim that BLA 125469 was approved on
September 18, 2014.
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 1,249 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 https://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.

Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30399 Filed 12-16-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices 91939

an approval phase. For human 1. The date an exemption under 5630 Fishers Lane, Rm. 1061, Rockville,
biological products, the testing phase section 505(i) of the Federal Food, Drug, MD 20852.
begins when the exemption to permit and Cosmetic Act (21 U.S.C. 355(i)) Dated: December 14, 2016.
the clinical investigations of the became effective: September 4, 2005. Leslie Kux,
biological becomes effective and runs FDA has verified the applicant’s claim
Associate Commissioner for Policy.
until the approval phase begins. The that the date the investigational new
drug application became effective was [FR Doc. 2016–30399 Filed 12–16–16; 8:45 am]
approval phase starts with the initial
submission of an application to market on September 4, 2005. BILLING CODE 4164–01–P

the human biological product and 2. The date the application was
continues until FDA grants permission initially submitted with respect to the
human biological product under section DEPARTMENT OF HEALTH AND
to market the biological product.
351 of the Public Health Service Act (42 HUMAN SERVICES
Although only a portion of a regulatory
review period may count toward the U.S.C. 262): September 18, 2013. The
Food and Drug Administration
actual amount of extension that the applicant claims September 17, 2013, as
Director of USPTO may award (for the date the biologics license
application (BLA) for TRULICITY (BLA [Docket Nos. FDA–2012–N–0873; FDA–
example, half the testing phase must be 2008–D–0031; FDA–2013–N–0242; FDA–
subtracted as well as any time that may 125469) was initially submitted.
2013–N–0125; FDA–2013–N–0093; FDA–
have occurred before the patent was However, FDA records indicate that 2016–N–1593; FDA–2015–N–2406; FDA–
issued), FDA’s determination of the BLA 125469 was submitted on 2013–N–0450; FDA–2011–N–0830]
length of a regulatory review period for September 18, 2013.
a human biological product will include 3. The date the application was Agency Information Collection
all of the testing phase and approval approved: September 18, 2014. FDA has Activities; Announcement of Office of
phase as specified in 35 U.S.C. verified the applicant’s claim that BLA Management and Budget Approvals
156(g)(1)(B). 125469 was approved on September 18,
2014. AGENCY: Food and Drug Administration,
FDA has approved for marketing the HHS.
This determination of the regulatory
human biologic product TRULICITY
review period establishes the maximum ACTION: Notice.
(dulaglutide). TRULICITY is indicated
potential length of a patent extension.
as an adjunct to diet and exercise to However, the USPTO applies several SUMMARY: The Food and Drug
improve glycemic control in adults with statutory limitations in its calculations Administration (FDA) is publishing a
type 2 diabetes mellitus. Subsequent to of the actual period for patent extension. list of information collections that have
this approval, the USPTO received a In its application for patent extension, been approved by the Office of
patent term restoration application for this applicant seeks 1,249 days of patent Management and Budget (OMB) under
TRULICITY (U.S. Patent No. 7,452,966) term extension. the Paperwork Reduction Act of 1995.
from Eli Lilly and Company, and the
III. Petitions FOR FURTHER INFORMATION CONTACT: FDA
USPTO requested FDA’s assistance in
determining this patent’s eligibility for PRA Staff, Office of Operations, Food
Anyone with knowledge that any of and Drug Administration, Three White
patent term restoration. In a letter dated the dates as published are incorrect may
October 15, 2015, FDA advised the Flint North, 11601 Landsdown St.,
submit either electronic or written North Bethesda, MD 20852,
USPTO that this human biological comments and ask for a redetermination
product had undergone a regulatory PRAStaff@fda.hhs.gov.
(see DATES). Furthermore, any interested
review period and that the approval of person may petition FDA for a SUPPLEMENTARY INFORMATION: The
TRULICITY represented the first determination regarding whether the following is a list of FDA information
permitted commercial marketing or use applicant for extension acted with due collections recently approved by OMB
of the product. Thereafter, the USPTO diligence during the regulatory review under section 3507 of the Paperwork
requested that FDA determine the period. To meet its burden, the petition Reduction Act of 1995 (44 U.S.C. 3507).
product’s regulatory review period. must be timely (see DATES) and contain The OMB control number and
sufficient facts to merit an FDA expiration date of OMB approval for
II. Determination of Regulatory Review
investigation. (See H. Rept. 857, part 1, each information collection are shown
Period
98th Cong., 2d sess., pp. 41–42, 1984.) in table 1. Copies of the supporting
FDA has determined that the Petitions should be in the format statements for the information
applicable regulatory review period for specified in 21 CFR 10.30. collections are available on the Internet
TRULICITY is 3,303 days. Of this time, Submit petitions electronically to at http://www.reginfo.gov/public/do/
2,937 days occurred during the testing https://www.regulations.gov at Docket PRAMain. An Agency may not conduct
phase of the regulatory review period, No. FDA–2013–S–0610. Submit written or sponsor, and a person is not required
while 366 days occurred during the petitions (two copies are required) to the to respond to, a collection of
approval phase. These periods of time Division of Dockets Management (HFA– information unless it displays a
were derived from the following dates: 305), Food and Drug Administration, currently valid OMB control number.

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
sradovich on DSK3GMQ082PROD with NOTICES

Title of collection No. expires

Bar Code Label Requirements for Human Drug Products and Biological Products .............................................. 0910–0537 9/30/2019
Clinical Laboratory Improvement Amendments Waiver Applications ..................................................................... 0910–0598 9/30/2019
Current Good Manufacturing Practices for Positron Emission Tomography Drugs ............................................... 0910–0667 9/30/2019
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling .... 0910–0740 9/30/2019
Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity
New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act .......... 0910–0746 9/30/2019

VerDate Sep<11>2014 20:55 Dec 16, 2016 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\19DEN1.SGM 19DEN1

Document Created: 2016-12-17 03:15:44
Document Modified: 2016-12-17 03:15:44

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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 17, 2017. 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 June 19, 2017. 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 91938

81 FR 91938 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRULICITY

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 243 (December 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration