83 FR 6198 - Determination of Regulatory Review Period for Purposes of Patent Extension; FARYDAK

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 30 (February 13, 2018)

Page Range		6198-6199
FR Document		2018-02868

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FARYDAK 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 30 (Tuesday, February 13, 2018)

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6198-6199]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02868]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2666; FDA-2015-E-2758; and FDA-2015-E-2664]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for FARYDAK 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 (in 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-2015-E-2666; FDA-2015-E-2758; and FDA-2015-E-2664 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; FARYDAK.'' 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:

[[Page 6199]]

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 FARYDAK
(panobinostat). FARYDAK, in combination with bortezomib and
dexamethasone, is indicated for the treatment of patients with multiple
myeloma who have received at least 2 prior regimens, including
bortezomib and an immunomodulatory agent. This indication is approved
under accelerated approval based on progression free survival.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials. Subsequent to this approval, the USPTO received patent term
restoration applications for FARYDAK (U.S. Patent Nos. 6,552,065;
6,833,384; and 7,067,551) from Novartis AG, and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated October 15, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of FARYDAK 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
FARYDAK is 4,334 days. Of this time, 3,997 days occurred during the
testing phase of the regulatory review period, while 337 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: April 15, 2003. The applicant claims April 15, 2002, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was April 15,
2003, which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: March 24,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for FARYDAK (NDA 205353) was initially submitted on
March 24, 2014.
3. The date the application was approved: February 23, 2015. FDA
has verified the applicant's claim that NDA 205353 was approved on
February 23, 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 1,751 days or 5 years 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 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02868 Filed 2-12-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices 6199

I. Background approval of FARYDAK represented the investigation, and must certify that a
The Drug Price Competition and first permitted commercial marketing or true and complete copy of the petition
Patent Term Restoration Act of 1984 use of the product. Thereafter, the has been served upon the patent
(Pub. L. 98–417) and the Generic USPTO requested that FDA determine applicant. (See H. Rept. 857, part 1, 98th
Animal Drug and Patent Term the product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.)
Restoration Act (Pub. L. 100–670) II. Determination of Regulatory Review Petitions should be in the format
generally provide that a patent may be Period specified in 21 CFR 10.30.
extended for a period of up to 5 years Submit petitions electronically to
FDA has determined that the https://www.regulations.gov at Docket
so long as the patented item (human applicable regulatory review period for
drug product, animal drug product, No. FDA–2013–S–0610. Submit written
FARYDAK is 4,334 days. Of this time, petitions (two copies are required) to the
medical device, food additive, or color 3,997 days occurred during the testing
additive) was subject to regulatory Dockets Management Staff (HFA–305),
phase of the regulatory review period, Food and Drug Administration, 5630
review by FDA before the item was while 337 days occurred during the
marketed. Under these acts, a product’s Fishers Lane, Rm. 1061, Rockville, MD
approval phase. These periods of time 20852.
regulatory review period forms the basis were derived from the following dates:
for determining the amount of extension 1. The date an exemption under Dated: February 6, 2018.
an applicant may receive. section 505(i) of the Federal Food, Drug, Leslie Kux,
A regulatory review period consists of and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
two periods of time: A testing phase and U.S.C. 355(i)) became effective: April [FR Doc. 2018–02868 Filed 2–12–18; 8:45 am]
an approval phase. For human drug 15, 2003. The applicant claims April 15, BILLING CODE 4164–01–P
products, the testing phase begins when 2002, as the date the investigational new
the exemption to permit the clinical drug application (IND) became effective.
investigations of the drug becomes However, FDA records indicate that the DEPARTMENT OF HEALTH AND
effective and runs until the approval IND effective date was April 15, 2003, HUMAN SERVICES
phase begins. The approval phase starts which was the first date after receipt of
with the initial submission of an the IND that the investigational studies Food and Drug Administration
application to market the human drug were allowed to proceed.
product and continues until FDA grants 2. The date the application was [Docket No. FDA–2018–N–0417]
permission to market the drug product. initially submitted with respect to the
Although only a portion of a regulatory human drug product under section Request for Nominations on the
review period may count toward the 505(b) of the FD&C Act: March 24, 2014. National Mammography Quality
actual amount of extension that the FDA has verified the applicant’s claim Assurance Advisory Committee
Director of USPTO may award (for that the new drug application (NDA) for
example, half the testing phase must be AGENCY: Food and Drug Administration,
FARYDAK (NDA 205353) was initially HHS.
subtracted as well as any time that may submitted on March 24, 2014.
have occurred before the patent was 3. The date the application was ACTION: Notice.
issued), FDA’s determination of the approved: February 23, 2015. FDA has SUMMARY: The Food and Drug
length of a regulatory review period for verified the applicant’s claim that NDA Administration (FDA) is requesting that
a human drug product will include all 205353 was approved on February 23, any industry organizations interested in
of the testing phase and approval phase 2015. participating in the selection of
as specified in 35 U.S.C. 156(g)(1)(B). This determination of the regulatory
FDA has approved for marketing the nonvoting industry representatives to
review period establishes the maximum serve on the National Mammography
human drug product FARYDAK potential length of a patent extension.
(panobinostat). FARYDAK, in Quality Assurance Advisory Committee
However, the USPTO applies several in the Center for Devices and
combination with bortezomib and statutory limitations in its calculations
dexamethasone, is indicated for the Radiological Health notify FDA in
of the actual period for patent extension. writing. FDA is also requesting
treatment of patients with multiple In its applications for patent extension,
myeloma who have received at least 2 nominations for a nonvoting industry
this applicant seeks 1,751 days or 5 representative to serve on the National
prior regimens, including bortezomib years of patent term extension.
and an immunomodulatory agent. This Mammography Quality Assurance
indication is approved under III. Petitions Advisory Committee. A nominee may
accelerated approval based on Anyone with knowledge that any of either be self-nominated or nominated
progression free survival. Continued the dates as published are incorrect may by an organization to serve as a
approval for this indication may be submit either electronic or written nonvoting industry representative.
contingent upon verification and comments and, under 21 CFR 60.24, ask Nominations will be accepted for an
description of clinical benefit in for a redetermination (see DATES). upcoming vacancy effective with this
confirmatory trials. Subsequent to this Furthermore, as specified in § 60.30 (21 notice.
approval, the USPTO received patent CFR 60.30), any interested person may DATES: Any industry organization
term restoration applications for petition FDA for a determination interested in participating in the
FARYDAK (U.S. Patent Nos. 6,552,065; regarding whether the applicant for selection of an appropriate nonvoting
6,833,384; and 7,067,551) from Novartis extension acted with due diligence member to represent industry interests
sradovich on DSK3GMQ082PROD with NOTICES

AG, and the USPTO requested FDA’s during the regulatory review period. To must send a letter stating that interest to
assistance in determining the patents’ meet its burden, the petition must FDA by March 15, 2018 (see sections I
eligibility for patent term restoration. In comply with all the requirements of and II of this document for further
a letter dated October 15, 2015, FDA § 60.30, including but not limited to: details). Concurrently, nomination
advised the USPTO that this human Must be timely (see DATES), must be materials for prospective candidates
drug product had undergone a filed in accordance with § 10.20, must should be sent to FDA by March 15,
regulatory review period and that the contain sufficient facts to merit an FDA 2018.

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Document Created: 2018-02-13 02:32:31
Document Modified: 2018-02-13 02:32:31

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 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 6198

83 FR 6198 - Determination of Regulatory Review Period for Purposes of Patent Extension; FARYDAK

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 30 (February 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration