83 FR 6026 - Determination of Regulatory Review Period for Purposes of Patent Extension; GILOTRIF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 29 (February 12, 2018)

Page Range		6026-6028
FR Document		2018-02767

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GILOTRIF 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 83 Issue 29 (Monday, February 12, 2018)

[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6026-6028]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02767]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2327]

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

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 GILOTRIF 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 April
13, 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 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 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:

[[Page 6027]]

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 No.
FDA-2014-E-2327 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; GILOTRIF.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
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 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 GILOTRIF
(afatinib dimaleate). GILOTRIF is indicated for the first-line
treatment of patients with metastatic non-small cell lung cancer whose
tumors have epidermal growth factor receptor exon 19 deletions or exon
21 substitution mutations as detected by an FDA approved test.
Subsequent to this approval, the USPTO received a patent term
restoration application for GILOTRIF (U.S. Patent No. RE43,431) from
Boehringer Ingelheim Pharma Gmbh & Co., KG, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated November 3, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of GILOTRIF 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
GILOTRIF is 3,453 days. Of this time, 3,213 days occurred during the
testing phase of the regulatory review period, while 240 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 30, 2004. FDA has verified the Boehringer Ingelheim
Pharma Gmbh & Co., KG claim that January 30, 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: November
15, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for GILOTRIF (NDA 201292) was initially submitted on
November 15, 2012.
3. The date the application was approved: July 12, 2013. FDA has
verified the applicant's claim that NDA 201292 was approved on July 12,
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 1,057 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, 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 be timely comply with all the requirements of Sec.
60.30, including but

[[Page 6028]]

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 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02767 Filed 2-9-18; 8:45 am]
BILLING CODE 4164-01-P

6028 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices

not limited to: Must be timely (see primary goal, CDER has initiated Offices in the firms’ respective regions.
DATES), must be filed in accordance with various training and development Firms that want to learn more about this
§ 10.20, must contain sufficient facts to programs to promote high performance training opportunity or that are
merit an FDA investigation, and must in its regulatory project management interested in offering a site tour should
certify that a true and complete copy of staff. CDER seeks to significantly respond by sending a proposed agenda
the petition has been served upon the enhance review efficiency and review by email directly to Dan Brum (see
patent applicant. (See H. Rept. 857, part quality by providing the staff with a DATES and FOR FURTHER INFORMATION
1, 98th Cong., 2d sess., pp. 41–42, 1984.) better understanding of the CONTACT).
Petitions should be in the format pharmaceutical industry and its Dated: February 6, 2018.
specified in 21 CFR 10.30. operations. To this end, CDER is Leslie Kux,
Submit petitions electronically to continuing its training program to give
Associate Commissioner for Policy.
https://www.regulations.gov at Docket regulatory project managers the
[FR Doc. 2018–02793 Filed 2–9–18; 8:45 am]
No. FDA–2013–S–0610. Submit written opportunity to tour pharmaceutical
BILLING CODE 4164–01–P
petitions (two copies are required) to the facilities. The goals are to provide the
Dockets Management Staff (HFA–305), following: (1) Firsthand exposure to
Food and Drug Administration, 5630 industry’s drug development processes
DEPARTMENT OF HEALTH AND
Fishers Lane, Rm. 1061, Rockville, MD and (2) a venue for sharing information
HUMAN SERVICES
20852. about project management procedures
Dated: February 6, 2018.
(but not drug-specific information) with Food and Drug Administration
industry representatives.
Leslie Kux, [Docket No. FDA–2014–E–2373]
Associate Commissioner for Policy. II. The Site Tours Program
[FR Doc. 2018–02767 Filed 2–9–18; 8:45 am] In this program, over a 2- to 3-day Determination of Regulatory Review
BILLING CODE 4164–01–P period, small groups (five or less) of Period for Purposes of Patent
regulatory project managers, including a Extension; IMBRUVICA
senior level regulatory project manager, AGENCY: Food and Drug Administration,
DEPARTMENT OF HEALTH AND can observe operations of HHS.
HUMAN SERVICES pharmaceutical manufacturing and/or ACTION: Notice.
packaging facilities, pathology/
Food and Drug Administration toxicology laboratories, and regulatory SUMMARY: The Food and Drug
[Docket No. FDA–2014–N–0179] affairs operations. Neither this tour nor Administration (FDA or the Agency) has
any part of the program is intended as determined the regulatory review period
Training Program for Regulatory a mechanism to inspect, assess, judge, for IMBRUVICA and is publishing this
Project Managers; Information or perform a regulatory function, but is notice of that determination as required
Available to Industry meant rather to improve mutual by law. FDA has made the
understanding and to provide an avenue determination because of the
AGENCY: Food and Drug Administration, for open dialogue. During the Site Tours submission of an application to the
HHS. Program, regulatory project managers Director of the U.S. Patent and
ACTION: Notice. will also participate in daily workshops Trademark Office (USPTO), Department
with their industry counterparts, of Commerce, for the extension of a
SUMMARY: The Food and Drug
focusing on selective regulatory issues patent which claims that human drug
Administration’s (FDA’s) Center for
important to both CDER staff and product.
Drug Evaluation and Research (CDER) is
industry. The primary objective of the
announcing the continuation of the DATES: Anyone with knowledge that any
daily workshops is to learn about the
Regulatory Project Management Site of the dates as published (in the
team approach to drug development,
Tours and Regulatory Interaction SUPPLEMENTARY INFORMATION section) are
including drug discovery, preclinical
Program (the Site Tours Program). The incorrect may submit either electronic
evaluation, tracking mechanisms, and
purpose of this document is to invite or written comments and ask for a
regulatory submission operations. The
pharmaceutical companies interested in redetermination by April 13, 2018. See
overall benefit to regulatory project
participating in this program to contact ‘‘Petitions’’ in the SUPPLEMENTARY
managers will be exposure to project
CDER. INFORMATION section for more
management, team techniques, and
DATES: Pharmaceutical companies may information.
processes employed by the
send proposed agendas to the Agency by pharmaceutical industry. By ADDRESSES: You may submit comments
April 13, 2018. participating in this program, the as follows. Please note that late,
FOR FURTHER INFORMATION CONTACT: Dan regulatory project manager will grow untimely filed comments will not be
Brum, Center for Drug Evaluation and professionally by gaining a better considered. Electronic comments must
Research, Food and Drug understanding of industry processes and be submitted on or before April 13,
Administration, 10903 New Hampshire procedures. 2018. The https://www.regulations.gov
Ave., Bldg. 22, Rm. 5480, Silver Spring, electronic filing system will accept
MD 20993–0002, 301–796–0578, III. Site Selection comments until midnight Eastern Time
dan.brum@fda.hhs.gov. All travel expenses associated with at the end of April 13, 2018. Comments
SUPPLEMENTARY INFORMATION: the Site Tours Program will be the received by mail/hand delivery/courier
daltland on DSKBBV9HB2PROD with NOTICES

responsibility of CDER; therefore, (for written/paper submissions) will be
I. Background selection will be based on the considered timely if they are
An important part of CDER’s availability of funds and resources for postmarked or the delivery service
commitment to make safe and effective each fiscal year. Selection will also be acceptance receipt is on or before that
drugs available to all Americans is based on firms having a favorable date. Furthermore, any interested
optimizing the efficiency and quality of facility status as determined by FDA’s person may petition FDA for a
the drug review process. To support this Office of Regulatory Affairs District determination regarding whether the

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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 April 13, 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 6026

83 FR 6026 - Determination of Regulatory Review Period for Purposes of Patent Extension; GILOTRIF

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 29 (February 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration