80 FR 33527 - Determination of Regulatory Review Period for Purposes of Patent Extension; XELJANZ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

Page Range		33527-33528
FR Document		2015-14433

The Food and Drug Administration (FDA) has determined the regulatory review period for XELJANZ 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 113 (Friday, June 12, 2015)

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33527-33528]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-14433]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1656]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XELJANZ 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 XELJANZ
(tofacitinib citrate). XELJANZ is indicated for the treatment of adult
patients with moderately to severely active rheumatoid arthritis who
have had an inadequate response or intolerance to methotrexate.
Subsequent to this approval, the USPTO received a patent term
restoration application for XELJANZ (U.S. Patent No. RE41,783) from
Pfizer Inc., and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated March 26, 2014, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of XELJANZ 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
XELJANZ is 3,947 days. Of this time, 3,564 days occurred during the
testing phase of the regulatory review period, while 383 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: January 18, 2002. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on January 18, 2002.

[[Page 33528]]

2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
21, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for XELJANZ (NDA 203214) was submitted on October 21,
2011.
3. The date the application was approved: November 6, 2012. FDA has
verified the applicant's claim that NDA 203214 was approved on November
6, 2012.
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 5 years 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 August 11, 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 December 9, 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: June 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14433 Filed 6-11-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices 33527

pre- or post-conception exposure of a GuidanceCompliance regulatory review period forms the basis
male to an API. Such male-mediated RegulatoryInformation/Guidances/ for determining the amount of extension
developmental toxicity may result from default.htm or http:// an applicant may receive.
an effect of the API on the male germ www.regulations.gov. A regulatory review period consists of
cell before conception or occur as a Dated: June 8, 2015. two periods of time: A testing phase and
result of direct exposure of the Leslie Kux, an approval phase. For human drug
conceptus to the pharmaceutical products, the testing phase begins when
Associate Commissioner for Policy.
following seminal transfer and vaginal the exemption to permit the clinical
[FR Doc. 2015–14363 Filed 6–11–15; 8:45 am]
uptake in a pregnant partner. investigations of the drug becomes
This draft guidance provides BILLING CODE 4164–01–P
effective and runs until the approval
recommendations for addressing the phase begins. The approval phase starts
potential for male-mediated adverse with the initial submission of an
DEPARTMENT OF HEALTH AND
effects on pregnancy outcome for application to market the human drug
HUMAN SERVICES
sponsors developing an investigational product and continues until FDA grants
drug. Topics covered include: (1) Food and Drug Administration permission to market the drug product.
Factors that investigators should Although only a portion of a regulatory
consider when testing a new API in [Docket No. FDA–2013–E–1656]
review period may count toward the
males, (2) nonclinical studies relevant to actual amount of extension that the
Determination of Regulatory Review
the assessment of male-mediated Director of USPTO may award (for
Period for Purposes of Patent
developmental risks, and (3) measures example, half the testing phase must be
Extension; XELJANZ
to prevent pregnancy or seminal transfer subtracted as well as any time that may
to a pregnant sexual partner when risk AGENCY: Food and Drug Administration, have occurred before the patent was
is either unknown or anticipated. HHS. issued), FDA’s determination of the
This draft guidance is being issued ACTION: Notice. length of a regulatory review period for
consistent with FDA’s good guidance a human drug product will include all
practices regulation (21 CFR 10.115). SUMMARY: The Food and Drug of the testing phase and approval phase
The draft guidance, when finalized, will Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B).
represent the current thinking of FDA the regulatory review period for
FDA has approved for marketing the
on the assessment of male-mediated XELJANZ and is publishing this notice
human drug product XELJANZ
developmental risk for pharmaceuticals. of that determination as required by
(tofacitinib citrate). XELJANZ is
It does not establish any rights for any law. FDA has made the determination
indicated for the treatment of adult
person and is not binding on FDA or the because of the submission of an
patients with moderately to severely
public. You can use an alternative application to the Director of the U.S.
active rheumatoid arthritis who have
approach if it satisfies the requirements Patent and Trademark Office (USPTO),
had an inadequate response or
of the applicable statutes and Department of Commerce, for the
intolerance to methotrexate. Subsequent
regulations. extension of a patent which claims that
to this approval, the USPTO received a
human drug product.
II. The Paperwork Reduction Act of patent term restoration application for
ADDRESSES: Submit electronic XELJANZ (U.S. Patent No. RE41,783)
1995
comments to http:// from Pfizer Inc., and the USPTO
This guidance refers to previously www.regulations.gov. Submit written requested FDA’s assistance in
approved collections of information that petitions (two copies are required) and determining this patent’s eligibility for
are subject to review by the Office of written comments to the Division of patent term restoration. In a letter dated
Management and Budget (OMB) under Dockets Management (HFA–305), Food March 26, 2014, FDA advised the
the Paperwork Reduction Act of 1995 and Drug Administration, 5630 Fishers USPTO that this human drug product
(44 U.S.C. 3501–3520). The collections Lane, Rm. 1061, Rockville, MD 20852. had undergone a regulatory review
of information in 21 CFR part 312 have Submit petitions electronically to http:// period and that the approval of
been approved under OMB control www.regulations.gov at Docket No. XELJANZ represented the first
number 0910–0014. FDA–2013–S–0610. permitted commercial marketing or use
III. Comments FOR FURTHER INFORMATION CONTACT: of the product. Thereafter, the USPTO
Beverly Friedman, Office of requested that FDA determine the
Interested persons may submit either
Management, Food and Drug product’s regulatory review period.
electronic comments regarding this
Administration, 10001 New Hampshire FDA has determined that the
document to http://www.regulations.gov
Ave., Hillandale Campus, Rm. 3180, applicable regulatory review period for
or written comments to the Division of
Silver Spring, MD 20993, 301–796– XELJANZ is 3,947 days. Of this time,
Dockets Management (see ADDRESSES). It
7900. 3,564 days occurred during the testing
is only necessary to send one set of
comments. Identify comments with the SUPPLEMENTARY INFORMATION: The Drug phase of the regulatory review period,
docket number found in brackets in the Price Competition and Patent Term while 383 days occurred during the
heading of this document. Received Restoration Act of 1984 (Pub. L. 98–417) approval phase. These periods of time
comments may be seen in the Division and the Generic Animal Drug and Patent were derived from the following dates:
of Dockets Management between 9 a.m. Term Restoration Act (Pub. L. 100–670) 1. The date an exemption under
mstockstill on DSK4VPTVN1PROD with NOTICES

and 4 p.m., Monday through Friday, and generally provide that a patent may be section 505(i) of the Federal Food, Drug,
will be posted to the docket at http:// extended for a period of up to 5 years and Cosmetic Act (the FD&C Act) (21
www.regulations.gov. so long as the patented item (human U.S.C. 355(i)) became effective: January
drug product, animal drug product, 18, 2002. FDA has verified the
IV. Electronic Access medical device, food additive, or color applicant’s claim that the date the
Persons with access to the Internet additive) was subject to regulatory investigational new drug application
may obtain the document at either review by FDA before the item was became effective was on January 18,
http://www.fda.gov/Drugs/ marketed. Under these acts, a product’s 2002.

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33528 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices

2. The date the application was DEPARTMENT OF HEALTH AND interested persons until November 12,
initially submitted with respect to the HUMAN SERVICES 2013, to comment on the draft guidance.
human drug product under section In the Federal Register of December 10,
505(b) of the FD&C Act: October 21, Food and Drug Administration 2013 (78 FR 74154), FDA published a
2011. FDA has verified the applicant’s [Docket No. FDA–2013–D–0928] notice reopening the comment period
claim that the new drug application for the draft guidance giving interested
(NDA) for XELJANZ (NDA 203214) was Recommendations for Preparation and persons until January 9, 2014, to
submitted on October 21, 2011. Submission of Animal Food Additive comment on the draft guidance.
Petitions; Guidance for Industry;
3. The date the application was FDA received four comments on the
Availability
approved: November 6, 2012. FDA has draft guidance and considered those
verified the applicant’s claim that NDA AGENCY: Food and Drug Administration, comments as we finalized the guidance.
203214 was approved on November 6, HHS. The guidance announced in this notice
2012. ACTION: Notice. finalizes the draft guidance dated
This determination of the regulatory September 2013.
SUMMARY: The Food and Drug
review period establishes the maximum II. Significance of Guidance
Administration (FDA) is announcing the
potential length of a patent extension. availability of a guidance for industry
However, the USPTO applies several This level 1 guidance is being issued
(GFI) #221 entitled ‘‘Recommendations
statutory limitations in its calculations consistent with FDA’s good guidance
for Preparation and Submission of
of the actual period for patent extension. Animal Food Additive Petitions.’’ This practices regulation (21 CFR 10.115).
In its application for patent extension, guidance describes the types of The guidance represents the current
this applicant seeks 5 years of patent information that FDA’s Center for thinking of FDA on recommendations
term extension. Veterinary Medicine recommends for for preparation and submission of
Anyone with knowledge that any of inclusion in food additive petitions animal food additive petitions. It does
the dates as published are incorrect may submitted for food additives intended not establish any rights for any person
submit to the Division of Dockets for use in food for animals. It is and is not binding on FDA or the public.
intended to help the petitioner submit You can use an alternative approach if
Management (see ADDRESSES) either
this information in a consistent and it satisfies the requirements of the
electronic or written comments and ask
appropriate manner. applicable statutes and regulations.
for a redetermination by August 11,
2015. Furthermore, any interested DATES: Submit either electronic or III. Paperwork Reduction Act of 1995
person may petition FDA for a written comments on Agency guidances
determination regarding whether the at any time. This guidance refers to previously
applicant for extension acted with due ADDRESSES: Submit written requests for approved collections of information
diligence during the regulatory review single copies of the guidance to the found in FDA regulations. These
period by December 9, 2015. To meet its Policy and Regulations Staff (HFV–6), collections of information are subject to
burden, the petition must contain Center for Veterinary Medicine, Food review by the Office of Management and
sufficient facts to merit an FDA and Drug Administration, 7519 Standish Budget (OMB) under the Paperwork
investigation. (See H. Rept. 857, part 1, Pl., Rockville, MD 20855. Send one self- Reduction Act of 1995 (44 U.S.C. 3501–
98th Cong., 2d sess., pp. 41–42, 1984.) addressed adhesive label to assist that 3520). The collections of information in
Petitions should be in the format office in processing your requests. See 21 CFR 571.1 and 571.6 have been
specified in 21 CFR 10.30. the SUPPLEMENTARY INFORMATION section approved under OMB control number
for electronic access to the guidance 0910–0546.
Interested persons may submit to the document.
Division of Dockets Management (see Submit electronic comments on the IV. Comments
ADDRESSES) electronic or written guidance to http://www.regulations.gov.
comments and written or electronic Interested persons may submit either
Submit written comments to the electronic comments regarding this
petitions. It is only necessary to send Division of Dockets Management (HFA–
one set of comments. Identify comments document to http://www.regulations.gov
305), Food and Drug Administration,
with the docket number found in or written comments to the Division of
5630 Fishers Lane, Rm. 1061, Rockville,
brackets in the heading of this Dockets Management (see ADDRESSES). It
MD 20852.
document. If you submit a written is only necessary to send one set of
FOR FURTHER INFORMATION CONTACT:
petition, two copies are required. A comments. Identify comments with the
Center for Veterinary Medicine, docket number found in brackets in the
petition submitted electronically must Division of Animal Feeds (HFV–220),
be submitted to http:// heading of this document. Received
Food and Drug Administration, 7519
www.regulations.gov, Docket No. FDA– comments may be seen in the Division
Standish Pl., Rockville, MD 20855, 240–
2013–S–0610. Comments and petitions of Dockets Management between 9 a.m.
402–7077; AskCVM@fda.hhs.gov, in the
that have not been made publicly subject line please include ATTN: and 4 p.m., Monday through Friday, and
available on http://www.regulations.gov Division of Animal Feeds. will be posted to the docket at http://
may be viewed in the Division of www.regulations.gov.
SUPPLEMENTARY INFORMATION:
Dockets Management between 9 a.m.
mstockstill on DSK4VPTVN1PROD with NOTICES

V. Electronic Access
and 4 p.m., Monday through Friday. I. Background
In the Federal Register of September Persons with access to the Internet
Dated: June 9, 2015.
11, 2013 (78 FR 55727), FDA published may obtain the guidance at either http://
Leslie Kux, www.fda.gov/AnimalVeterinary/
the notice of availability for a draft
Associate Commissioner for Policy. guidance entitled ‘‘Recommendations GuidanceComplianceEnforcement/
[FR Doc. 2015–14433 Filed 6–11–15; 8:45 am] for Preparation and Submission of GuidanceforIndustry/default.htm or
BILLING CODE 4164–01–P Animal Food Additive Petitions’’ giving http://www.regulations.gov.

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Document Created: 2018-02-22 10:16:33
Document Modified: 2018-02-22 10:16:33

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 33527

80 FR 33527 - Determination of Regulatory Review Period for Purposes of Patent Extension; XELJANZ

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration