83 FR 6581 - Determination of Regulatory Review Period for Purposes of Patent Extension; IBRANCE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 31 (February 14, 2018)

Page Range		6581-6582
FR Document		2018-03029

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IBRANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 83 Issue 31 (Wednesday, February 14, 2018)

[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6581-6582]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-03029]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1184 and FDA-2016-E-1183]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for IBRANCE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications 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 (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. 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 13, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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 Nos.
FDA-2016-E-1184 and FDA-2016-E-1183 for ``For Determination of
Regulatory Review Period for Purposes of Patent Extension; IBRANCE.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the dockets and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 Sec. 10.20 (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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 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

[[Page 6582]]

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 IBRANCE
(palbociclib). IBRANCE is indicated for the treatment of hormone
receptor-positive, human epidermal growth factor receptor 2-negative
advanced or metastatic breast cancer in combination with:
An aromatase inhibitor as initial endocrine based therapy
in postmenopausal women; or
fulvestrant in women with disease progression following
endocrine therapy.
Subsequent to this approval, the USPTO received patent term
restoration applications for IBRANCE (U.S. Patent Nos. 6,936,612 and
7,208,489) from Warner-Lambert Company, LLC, and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated July 12, 2016, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of IBRANCE 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
IBRANCE is 3,954 days. Of this time, 3,779 days occurred during the
testing phase of the regulatory review period, while 175 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
April 9, 2004. FDA has verified the Warner-Lambert Company, LLC, claim
that April 9, 2004, is the date the investigational new drug
application (IND) 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: August 13,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for IBRANCE (NDA 207103) was initially submitted on
August 13, 2014.
3. The date the application was approved: February 3, 2015. FDA has
verified the applicant's claim that NDA 207103 was approved on February
3, 2015.
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 applications for patent extension,
this applicant seeks 1,810 days or 1,509 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, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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 Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03029 Filed 2-13-18; 8:45 am]
BILLING CODE 4164-01-P

6582 Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices

for determining the amount of extension 1. The date an exemption under Dated: February 8, 2018.
an applicant may receive. section 505(i) of the Federal Food, Drug, Leslie Kux,
A regulatory review period consists of and Cosmetic Act (FD&C Act) (21 U.S.C. Associate Commissioner for Policy.
two periods of time: A testing phase and 355(i)) became effective: April 9, 2004. [FR Doc. 2018–03029 Filed 2–13–18; 8:45 am]
an approval phase. For human drug FDA has verified the Warner-Lambert BILLING CODE 4164–01–P
products, the testing phase begins when Company, LLC, claim that April 9, 2004,
the exemption to permit the clinical is the date the investigational new drug
investigations of the drug becomes application (IND) became effective. DEPARTMENT OF HEALTH AND
effective and runs until the approval HUMAN SERVICES
2. The date the application was
phase begins. The approval phase starts
with the initial submission of an initially submitted with respect to the Food and Drug Administration
application to market the human drug human drug product under section
505(b) of the FD&C Act: August 13, [Docket No. FDA–2018–N–0001]
product and continues until FDA grants
permission to market the drug product. 2014. FDA has verified the applicant’s Utilizing Innovative Statistical Methods
Although only a portion of a regulatory claim that the new drug application and Trial Designs in Rare Disease
review period may count toward the (NDA) for IBRANCE (NDA 207103) was Settings; Public Workshop
actual amount of extension that the initially submitted on August 13, 2014.
Director of USPTO may award (for AGENCY: Food and Drug Administration,
3. The date the application was
example, half the testing phase must be HHS.
approved: February 3, 2015. FDA has
subtracted as well as any time that may verified the applicant’s claim that NDA ACTION: Notice of public workshop.
have occurred before the patent was 207103 was approved on February 3,
issued), FDA’s determination of the SUMMARY: The Food and Drug
2015. Administration (FDA) is announcing the
length of a regulatory review period for
a human drug product will include all This determination of the regulatory following 1-day public workshop
of the testing phase and approval phase review period establishes the maximum entitled ‘‘Utilizing Innovative Statistical
as specified in 35 U.S.C. 156(g)(1)(B). potential length of a patent extension. Methods and Trial Designs in Rare
However, the USPTO applies several Disease Settings.’’ This workshop is
FDA has approved for marketing the
statutory limitations in its calculations convened by the Duke-Robert J.
human drug product IBRANCE
of the actual period for patent extension. Margolis, MD, Center for Health Policy
(palbociclib). IBRANCE is indicated for
In its applications for patent extension, at Duke University and supported by a
the treatment of hormone receptor-
this applicant seeks 1,810 days or 1,509 cooperative agreement with FDA. The
positive, human epidermal growth
days of patent term extension. purpose of the public workshop is to
factor receptor 2-negative advanced or
bring rare disease stakeholders together
metastatic breast cancer in combination
III. Petitions to discuss the challenges associated
with:
with the development and regulatory
• An aromatase inhibitor as initial Anyone with knowledge that any of decision-making for rare disease
endocrine based therapy in the dates as published are incorrect may treatments and to also discuss
postmenopausal women; or submit either electronic or written promising study designs and analytical
• fulvestrant in women with disease comments and, under 21 CFR 60.24, ask methods that can help overcome these
progression following endocrine for a redetermination (see DATES). challenges.
therapy. Furthermore, as specified in § 60.30 (21 DATES: The public workshop will be
Subsequent to this approval, the CFR 60.30), any interested person may held on March 19, 2018, from 9 a.m. to
USPTO received patent term restoration petition FDA for a determination 5 p.m. Eastern Daylight Time (EDT). See
applications for IBRANCE (U.S. Patent regarding whether the applicant for the SUPPLEMENTARY INFORMATION section
Nos. 6,936,612 and 7,208,489) from extension acted with due diligence for registration date and information.
Warner-Lambert Company, LLC, and the
during the regulatory review period. To ADDRESSES: The public workshop will
USPTO requested FDA’s assistance in
meet its burden, the petition must be held at the DoubleTree by Hilton
determining the patents’ eligibility for
comply with all the requirements of Hotel Washington DC-Silver Spring,
patent term restoration. In a letter dated
July 12, 2016, FDA advised the USPTO § 60.30, including but not limited to: 8727 Colesville Rd., Silver Spring, MD
that this human drug product had Must be timely (see DATES), must be 20910. For additional travel and hotel
undergone a regulatory review period filed in accordance with § 10.20, must information, please refer to the Duke
and that the approval of IBRANCE contain sufficient facts to merit an FDA Margolis Center for Health Policy
represented the first permitted investigation, and must certify that a website at: https://
commercial marketing or use of the true and complete copy of the petition healthpolicy.duke.edu/events/
product. Thereafter, the USPTO has been served upon the patent innovative-tools-and-statistical-
requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th methods-treatment-development-rare-
product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) disease-settings.
Petitions should be in the format FOR FURTHER INFORMATION CONTACT:
II. Determination of Regulatory Review Robyn Bent, Center for Drug Evaluation
specified in 21 CFR 10.30.
Period and Research, Food and Drug
Submit petitions electronically to
FDA has determined that the https://www.regulations.gov at Docket Administration, 10903 New Hampshire
daltland on DSKBBV9HB2PROD with NOTICES

applicable regulatory review period for Ave., Silver Spring, MD 20993, 240–
No. FDA–2013–S–0610. Submit written
IBRANCE is 3,954 days. Of this time, 402–2572, Robyn.Bent@fda.hhs.gov.
petitions (two copies are required) to the
3,779 days occurred during the testing SUPPLEMENTARY INFORMATION:
Dockets Management Staff (HFA–305),
phase of the regulatory review period,
Food and Drug Administration, 5630 I. Background
while 175 days occurred during the
approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD Rare disease settings pose several
were derived from the following dates: 20852. significant challenges for clinical

VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1

Document Created: 2018-02-14 03:59:02
Document Modified: 2018-02-14 03:59:02

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 April 16, 2018. 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 13, 2018. 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		83 FR 6581

83 FR 6581 - Determination of Regulatory Review Period for Purposes of Patent Extension; IBRANCE

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 31 (February 14, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration