81 FR 63773 - Determination of Regulatory Review Period for Purposes of Patent Extension; ENTYVIO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 180 (September 16, 2016)

Page Range		63773-63774
FR Document		2016-22344

The Food and Drug Administration (FDA) has determined the regulatory review period for ENTYVIO 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. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Federal Register, Volume 81 Issue 180 (Friday, September 16, 2016)

[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63773-63774]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-22344]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2354]

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

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 ENTYVIO 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.
Patents and Trademarks 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
November 15, 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 March 15,
2017. 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-2354.
For Determination of Regulatory Review Period for Purposes of
Patent Extension: ENTYVIO. 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:

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 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

[[Page 63774]]

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 Patents and
Trademarks 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, ENTYVIO
(vedolizumab). ENTYVIO is indicated for adult ulcerative colitis and
adult Crohn's disease. Subsequent to this approval, the USPTO received
a patent term restoration application for ENTYVIO (U.S. Patent No.
7,147,851) from Millenium Pharmaceuticals, Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated January 6, 2016, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of ENTYVIO 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
ENTYVIO is 5,066 days. Of this time, 4,731 days occurred during the
testing phase of the regulatory review period, while 335 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: July 8,
2000. The applicant claims August 18, 2000, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 8, 2000,
which was 30 days after FDA receipt of the IND.
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): June 20, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ENTYVIO (BLA 125476) was initially submitted on June 20, 2013.
3. The date the application was approved: May 20, 2014. FDA has
verified the applicant's claim that BLA 125476 was approved on May 20,
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 1,526 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,
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: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22344 Filed 9-15-16; 8:45 am]
BILLING CODE 4164-01-P

63774 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices

submission of an application to market 3. The date the application was are planning to develop new
the human biological product and approved: May 20, 2014. FDA has antimicrobial drugs or ASTs and who
continues until FDA grants permission verified the applicant’s claim that BLA wish to coordinate development of these
to market the biological product. 125476 was approved on May 20, 2014. products, such that the AST device
Although only a portion of a regulatory This determination of the regulatory could be cleared either at the time of
review period may count toward the review period establishes the maximum new drug approval or shortly thereafter.
actual amount of extension that the potential length of a patent extension. The input from this public workshop
Director of Patents and Trademarks may However, the USPTO applies several will also help in developing topics for
award (for example, half the testing statutory limitations in its calculations future discussion.
phase must be subtracted as well as any of the actual period for patent extension. DATES: Dates and Times: The public
time that may have occurred before the In its application for patent extension, workshop will be held on September 29,
patent was issued), FDA’s determination this applicant seeks 1,526 days of patent 2016, from 9 a.m. to 4 p.m. See the
of the length of a regulatory review term extension. SUPPLEMENTARY INFORMATION section for
period for a human biological product III. Petitions registration information.
will include all of the testing phase and
Anyone with knowledge that any of ADDRESSES: Location: The public
approval phase as specified in 35 U.S.C.
156(g)(1)(B). the dates as published are incorrect may workshop will be held at the Sheraton
FDA has approved for marketing the submit either electronic or written Silver Spring Hotel, 8777 Georgia Ave.,
human biologic product, ENTYVIO comments and ask for a redetermination Silver Spring, MD 20910. The hotel’s
(vedolizumab). ENTYVIO is indicated (see DATES). Furthermore, any interested phone number is 301–589–0800.
for adult ulcerative colitis and adult person may petition FDA for a FOR FURTHER INFORMATION CONTACT:
Crohn’s disease. Subsequent to this determination regarding whether the Contact Persons: Lori Benner and/or
approval, the USPTO received a patent applicant for extension acted with due Jessica Barnes, Center for Drug
term restoration application for diligence during the regulatory review Evaluation and Research, Food and
ENTYVIO (U.S. Patent No. 7,147,851) period. To meet its burden, the petition Drug Administration, 10903 New
from Millenium Pharmaceuticals, Inc., must be timely (see DATES) and contain Hampshire Ave., Bldg. 22, Rm. 6221,
and the USPTO requested FDA’s sufficient facts to merit an FDA Silver Spring, MD 20993–0002, 301–
assistance in determining this patent’s investigation. (See H. Rept. 857, part 1, 796–1300.
eligibility for patent term restoration. In 98th Cong., 2d sess., pp. 41–42, 1984.) Registration: Registration is free for
a letter dated January 6, 2016, FDA Petitions should be in the format the public workshop. Interested parties
advised the USPTO that this human specified in 21 CFR 10.30. are encouraged to register early. Seating
biological product had undergone a Submit petitions electronically to will be available on a first-come, first-
regulatory review period and that the http://www.regulations.gov, Docket No. served basis. To register electronically,
approval of ENTYVIO represented the FDA–2013–S–0610. Submit written email your registration information
first permitted commercial marketing or petitions (two copies are required) to the (including name, title, firm name,
use of the product. Thereafter, the Division of Dockets Management (HFA– address, telephone number, and fax
USPTO requested that FDA determine 305), Food and Drug Administration, number) to AntimicrobialSusceptibility
the product’s regulatory review period. 5630 Fishers Lane, rm. 1061, Rockville, testingWorkshop2016@fda.hhs.gov.
MD 20852. Persons without access to the Internet
II. Determination of Regulatory Review
Period Dated: September 12, 2016. can call 301–796–1300 to register.
Leslie Kux, If you need special accommodations
FDA has determined that the due to a disability, please contact Jessica
Associate Commissioner for Policy.
applicable regulatory review period for Barnes or Lori Benner (see Contact
ENTYVIO is 5,066 days. Of this time, [FR Doc. 2016–22344 Filed 9–15–16; 8:45 am]
Persons above) at least 7 days in
4,731 days occurred during the testing BILLING CODE 4164–01–P
advance.
phase of the regulatory review period,
while 335 days occurred during the SUPPLEMENTARY INFORMATION: FDA is
approval phase. These periods of time DEPARTMENT OF HEALTH AND announcing a public workshop
were derived from the following dates: HUMAN SERVICES pertaining to the coordinated
1. The date an exemption under development of antimicrobial drugs and
Food and Drug Administration
section 505(i) of the Federal Food, Drug, ASTs. Discussions will focus on
and Cosmetic Act (21 U.S.C. 355(i)) [Docket No. FDA–2016–N–0001] assisting drug sponsors and device
became effective: July 8, 2000. The manufacturers who are planning to
applicant claims August 18, 2000, as the Coordinated Development of develop new antimicrobial drugs or
date the investigational new drug Antimicrobial Drugs and Antimicrobial ASTs and who seek to coordinate
application (IND) became effective. Susceptibility Test Devices development of these products.
However, FDA records indicate that the AGENCY: Food and Drug Administration, The goals of the workshop are to: (1)
IND effective date was July 8, 2000, HHS. Outline the regulatory considerations
which was 30 days after FDA receipt of ACTION: Notice of public workshop. for submitting separate applications to
the IND. the Center for Drug Evaluation and
2. The date the application was SUMMARY: The Food and Drug Research and the Center for Devices and
initially submitted with respect to the Administration (FDA or Agency) is Radiological Health for antimicrobial
mstockstill on DSK3G9T082PROD with NOTICES

human biological product under section announcing a public workshop drugs and ASTs, respectively; (2)
351 of the Public Health Service Act (42 regarding ‘‘Coordinated Development of identify the challenges related to
U.S.C. 262): June 20, 2013. FDA has Antimicrobial Drugs and Antimicrobial obtaining data supporting the clearance
verified the applicant’s claim that the Susceptibility Test Devices (ASTs).’’ of an AST device coincident with or
biologics license application (BLA) for This public workshop is intended to soon after antimicrobial drug approval;
ENTYVIO (BLA 125476) was initially facilitate discussion between drug and (3) discuss ideas for addressing
submitted on June 20, 2013. sponsors and device manufacturers who these challenges.

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Document Created: 2016-09-16 00:25:07
Document Modified: 2016-09-16 00:25:07

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 November 15, 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 March 15, 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 63773

81 FR 63773 - Determination of Regulatory Review Period for Purposes of Patent Extension; ENTYVIO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 180 (September 16, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration