81 FR 37606 - Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYST

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range		37606-37608
FR Document		2016-13796

The Food and Drug Administration (FDA) has determined the regulatory review period for POMALYST 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 81 Issue 112 (Friday, June 10, 2016)

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37606-37608]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-13796]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-1239; FDA-2015-E-0539]

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

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 POMALYST 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

[[Page 37607]]

redetermination by August 9, 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 December 7, 2016. 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 Nos.
FDA-2014-E-1239 and FDA-2015-E-0539 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; POMALYST.'' 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 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 POMALYST
(pomalidomide). POMALYST is indicated for treatment of patients with
multiple myeloma who have received at least two prior therapies
including lenalidomide and bortezomib and have demonstrated disease
progression on or within 60 days of completion of last therapy.
Subsequent to this approval, the USPTO received patent term restoration
applications for POMALYST (U.S. Patent Nos. 6,316,471 and 8,198,262)
from Celgene Corporation, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 11, 2015, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of POMALYST 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
POMALYST is 3,716 days. Of this time, 3,411 days occurred during the
testing phase of the regulatory review period, while 305 days occurred
during the

[[Page 37608]]

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: December 9, 2002. The applicant claims December 14, 2002, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was December 9, 2002, 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: April 10,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for POMALYST (NDA 204026) was initially submitted on
April 10, 2012.
3. The date the application was approved: February 8, 2013. FDA has
verified the applicant's claim that NDA 204026 was approved on February
8, 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 applications for patent extension,
this applicant seeks 5 years or 241 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 at
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: June 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13796 Filed 6-9-16; 8:45 am]
BILLING CODE 4164-01-P

37608 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices

approval phase. These periods of time 305), Food and Drug Administration, prospective candidates should be sent to
were derived from the following dates: 5630 Fishers Lane, Rm. 1061, Rockville, FDA (see ADDRESSES) by July 11, 2016.
1. The date an exemption under MD 20852. Nominations will be accepted for
section 505(i) of the Federal Food, Drug, Dated: June 3, 2016. current vacancies and for those that will
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, or may occur through August 31, 2016.
U.S.C. 355(i)) became effective: ADDRESSES: All statements of interest
Associate Commissioner for Policy.
December 9, 2002. The applicant claims from consumer organizations interested
[FR Doc. 2016–13796 Filed 6–9–16; 8:45 am]
December 14, 2002, as the date the in participating in the selection process
BILLING CODE 4164–01–P
investigational new drug application and consumer representative
(IND) became effective. However, FDA nominations should be submitted
records indicate that the IND effective electronically to kimberly.hamilton@
DEPARTMENT OF HEALTH AND
date was December 9, 2002, which was fda.hhs.gov, by mail to Advisory
HUMAN SERVICES
the first date after receipt of the IND that Committee Oversight and Management
the investigational studies were allowed Food and Drug Administration Staff, 10903 New Hampshire Ave., Bldg.
to proceed. 32, Rm. 5103, Silver Spring, MD 20993–
2. The date the application was [Docket No. FDA–2016–N–0001]
0002, or by FAX: 301–847–8640.
initially submitted with respect to the
Request for Nominations for Consumer representative nominations
human drug product under section
Individuals and Consumer should be submitted electronically by
505(b) of the FD&C Act: April 10, 2012.
Organizations for Advisory logging into the FDA Advisory
FDA has verified the applicant’s claim
Committees Committee Membership Nomination
that the new drug application (NDA) for
POMALYST (NDA 204026) was initially AGENCY: Food and Drug Administration, Portal: https://www.accessdata.fda.gov/
submitted on April 10, 2012. HHS. scripts/FACTRSPortal/FACTRS/
3. The date the application was index.cfm, by mail to Advisory
ACTION: Notice.
approved: February 8, 2013. FDA has Committee Oversight and Management
verified the applicant’s claim that NDA SUMMARY: The Food and Drug Staff, 10903 New Hampshire Ave., Bldg.
204026 was approved on February 8, Administration (FDA) is requesting that 32, Rm. 5103, Silver Spring, MD 20993–
2013. any consumer organizations interested 0002, or by FAX: 301–847–8640.
This determination of the regulatory in participating in the selection of Additional information about becoming
review period establishes the maximum voting and/or nonvoting consumer a member on an FDA advisory
potential length of a patent extension. representatives to serve on its advisory committee can also be obtained by
However, the USPTO applies several committees or panels notify FDA in visiting FDA’s Web site at http://
statutory limitations in its calculations writing. FDA is also requesting www.fda.gov/AdvisoryCommittees/
of the actual period for patent extension. nominations for voting and/or default.htm.
In its applications for patent extension, nonvoting consumer representatives to
FOR FURTHER INFORMATION CONTACT: For
this applicant seeks 5 years or 241 days serve on advisory committees and/or
questions relating to participation in the
of patent term extension. panels for which vacancies currently
selection process: Kimberly Hamilton,
exist or are expected to occur in the near
III. Petitions Advisory Committee Oversight and
future. Nominees recommended to serve
Management Staff (ACOMS), Food and
Anyone with knowledge that any of as a voting or nonvoting consumer
Drug Administration, 10903 New
the dates as published are incorrect may representative may be self-nominated or
Hampshire Ave., Bldg. 32, Rm. 5103,
submit either electronic or written may be nominated by a consumer
Silver Spring, MD 20993–0002, 301–
comments and ask for a redetermination organization.
FDA seeks to include the views of 796–8220 email: kimberly.hamilton@
(see DATES). Furthermore, any interested
women and men, members of all racial fda.hhs.gov.
person may petition FDA for a
determination regarding whether the and ethnic groups, and individuals with For questions relating to specific
applicant for extension acted with due and without disabilities on its advisory advisory committees or panels, contact
diligence during the regulatory review committees and, therefore, encourages the appropriate Contact Person listed in
period. To meet its burden, the petition nominations of appropriately qualified table 1 in the SUPPLEMENTARY
candidates from these groups. INFORMATION section:
must be timely (see DATES) and contain
sufficient facts to merit an FDA DATES: Any consumer organization SUPPLEMENTARY INFORMATION:
investigation. (See H. Rept. 857, part 1, interested in participating in the
I. Background
98th Cong., 2d sess., pp. 41–42, 1984.) selection of an appropriate voting or
Petitions should be in the format nonvoting member to represent FDA is requesting that any consumer
specified in 21 CFR 10.30. consumer interests on an FDA advisory organizations interested in participating
Submit petitions electronically to committee or panel may send a letter or in the selection of voting and/or
http://www.regulations.gov at Docket email stating that interest to FDA (see nonvoting consumer representatives to
No. FDA–2013–S–0610. Submit written ADDRESSES) by July 11, 2016, for serve on its advisory committees or
petitions (two copies are required) to the vacancies listed in this notice. panels notify FDA in writing (see table
Division of Dockets Management (HFA– Concurrently, nomination materials for 1 for Contact Person).
asabaliauskas on DSK3SPTVN1PROD with NOTICES

TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person Committee/panel

Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Allergenic Products Advisory Committee.
Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993–0002, Phone: 301–796–9016,
Email: Janie.Kim@fda.hhs.gov.

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Document Created: 2018-02-08 07:35:59
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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 August 9, 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 December 7, 2016. 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 37606

81 FR 37606 - Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYST

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration