80 FR 26271 - Determination of Regulatory Review Period for Purposes of Patent Extension; SYNRIBO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26271-26272
FR Document		2015-11004

The Food and Drug Administration (FDA) has determined the regulatory review period for SYNRIBO 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 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26271-26272]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-11004]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1690]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SYNRIBO 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 SYNRIBO
(omacetaxine mepesuccinate). SYNRIBO is indicated for treatment of
adult patients with chronic or accelerated phase chronic myeloid
leukemia with resistance and/or intolerance to two or more tyrosine
kinase inhibitors. Subsequent to this approval, the USPTO received a
patent term restoration application for SYNRIBO (U.S. Patent No.
6,987,103) from Robin, Mahon, Maisonneuve, Maloisel, and Blanchard, and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated January 30,
2014, FDA

[[Page 26272]]

advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of SYNRIBO 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
SYNRIBO is 4,182 days. Of this time, 3,037 days occurred during the
testing phase of the regulatory review period, while 1,145 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: May 17, 2001. The applicant claims May 18, 2001, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was May 17,
2001, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
8, 2009. The applicant claims September 4, 2009, as the date the new
drug application (NDA) for SYNRIBO was initially submitted. However,
FDA records indicate that the NDA was submitted on September 8, 2009.
3. The date the application was approved: October 26, 2012. FDA has
verified the applicant's claim that the NDA for SYNRIBO was approved on
October 26, 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 1,217 days 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 July 6, 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 November 3, 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: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11004 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26271

file a petition to participate in a formal hearing before a Public Board of Inquiry, The respondents are individuals or
evidentiary hearing, either personally or concerning disclosure of data and households, State or local governments,
through a representative. Section 12.45 information by participants (21 CFR not-for-profit institutions and
requires that any person filing a notice 13.25). In accordance with § 12.45(e) the businesses, or other for-profit groups
of participation state their specific presiding officer may omit a and institutions.
interest in the proceedings, including participant’s appearance. In the Federal Register of December
the specific issues of fact about which The presiding officer and other 10, 2014 (79 FR 73320), FDA published
the person desires to be heard. This participants will use the collected a 60-day notice requesting public
section also requires that the notice information in a hearing to identify comment on the proposed collection of
include a statement that the person will specific interests to be presented. This information. No comments were
present testimony at the hearing and preliminary information serves to received.
will comply with specific requirements expedite the prehearing conference and FDA estimates the burden of this
in 21 CFR 12.85, or, in the case of a commits participation. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of Total
21 CFR Section responses per annual burden per
respondents hours
respondent responses response

10.30—Citizen Petition ........................................................ 207 1 207 24 4,968
10.33—Administrative reconsideration of action ................. 4 1 4 10 40
10.35—Administrative Stay of Action .................................. 5 1 5 10 50
10.85—Advisory Opinions ................................................... 4 1 4 16 64
12.22—Filing Objections and Requests for a Hearing on a
Regulation or Order .......................................................... 3 1 3 20 60
12.45—Notice of Participation ............................................. 4 1 4 3 12

Total .............................................................................. ........................ ........................ ........................ ........................ 5,194
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimates for this ADDRESSES: Submit electronic products, the testing phase begins when
collection of information are based on comments to http:// the exemption to permit the clinical
Agency records and experience over the www.regulations.gov. Submit written investigations of the drug becomes
past 3 years. petitions (two copies are required) and effective and runs until the approval
Dated: May 1, 2015. written comments to the Division of phase begins. The approval phase starts
Dockets Management (HFA–305), Food with the initial submission of an
Leslie Kux,
and Drug Administration, 5630 Fishers application to market the human drug
Associate Commissioner for Policy.
Lane, Rm. 1061, Rockville, MD 20852. product and continues until FDA grants
[FR Doc. 2015–10996 Filed 5–6–15; 8:45 am] permission to market the drug product.
Submit petitions electronically to
BILLING CODE 4164–01–P http://www.regulations.gov at Docket Although only a portion of a regulatory
No. FDA–2013–S–0610. review period may count toward the
FOR FURTHER INFORMATION CONTACT:
actual amount of extension that the
DEPARTMENT OF HEALTH AND Director of USPTO may award (for
HUMAN SERVICES Beverly Friedman, Office of
Management, Food and Drug example, half the testing phase must be
Food and Drug Administration Administration, 10001 New Hampshire subtracted as well as any time that may
Ave., Hillandale Campus, Rm. 3180, have occurred before the patent was
Silver Spring, MD 20993, 301–796– issued), FDA’s determination of the
[Docket No. FDA–2013–E–1690]
7900. length of a regulatory review period for
Determination of Regulatory Review a human drug product will include all
SUPPLEMENTARY INFORMATION: The Drug of the testing phase and approval phase
Period for Purposes of Patent
Price Competition and Patent Term as specified in 35 U.S.C. 156(g)(1)(B).
Extension; SYNRIBO
Restoration Act of 1984 (Pub. L. 98–417) FDA has approved for marketing the
AGENCY: Food and Drug Administration, and the Generic Animal Drug and Patent human drug product SYNRIBO
HHS. Term Restoration Act (Pub. L. 100–670) (omacetaxine mepesuccinate). SYNRIBO
ACTION: Notice. generally provide that a patent may be is indicated for treatment of adult
extended for a period of up to 5 years patients with chronic or accelerated
SUMMARY: The Food and Drug so long as the patented item (human phase chronic myeloid leukemia with
Administration (FDA) has determined drug product, animal drug product, resistance and/or intolerance to two or
the regulatory review period for medical device, food additive, or color more tyrosine kinase inhibitors.
SYNRIBO and is publishing this notice additive) was subject to regulatory Subsequent to this approval, the USPTO
review by FDA before the item was
mstockstill on DSK4VPTVN1PROD with NOTICES

of that determination as required by received a patent term restoration
law. FDA has made the determination marketed. Under these acts, a product’s application for SYNRIBO (U.S. Patent
because of the submission of an regulatory review period forms the basis No. 6,987,103) from Robin, Mahon,
application to the Director of the U.S. for determining the amount of extension Maisonneuve, Maloisel, and Blanchard,
Patent and Trademark Office (USPTO), an applicant may receive. and the USPTO requested FDA’s
Department of Commerce, for the A regulatory review period consists of assistance in determining this patent’s
extension of a patent which claims that two periods of time: A testing phase and eligibility for patent term restoration. In
human drug product. an approval phase. For human drug a letter dated January 30, 2014, FDA

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26272 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

advised the USPTO that this human Interested persons may submit to the Ave., Hillandale Campus, Rm. 3180,
drug product had undergone a Division of Dockets Management (see Silver Spring, MD 20993, 301–796–
regulatory review period and that the ADDRESSES) electronic or written 7900.
approval of SYNRIBO represented the comments and written or electronic SUPPLEMENTARY INFORMATION: The Drug
first permitted commercial marketing or petitions. It is only necessary to send Price Competition and Patent Term
use of the product. Thereafter, the one set of comments. Identify comments Restoration Act of 1984 (Pub. L. 98–417)
USPTO requested that FDA determine with the docket number found in and the Generic Animal Drug and Patent
the product’s regulatory review period. brackets in the heading of this Term Restoration Act (Pub. L. 100–670)
FDA has determined that the document. If you submit a written generally provide that a patent may be
applicable regulatory review period for petition, two copies are required. A extended for a period of up to 5 years
SYNRIBO is 4,182 days. Of this time, petition submitted electronically must so long as the patented item (human
3,037 days occurred during the testing be submitted to http:// drug product, animal drug product,
phase of the regulatory review period, www.regulations.gov, Docket No. FDA– medical device, food additive, or color
while 1,145 days occurred during the 2013–S–0610. Comments and petitions additive) was subject to regulatory
approval phase. These periods of time that have not been made publicly review by FDA before the item was
were derived from the following dates: available on http://www.regulations.gov marketed. Under these acts, a product’s
1. The date an exemption under may be viewed in the Division of regulatory review period forms the basis
section 505(i) of the Federal Food, Drug, Dockets Management between 9 a.m. for determining the amount of extension
and Cosmetic Act (the FD&C Act) (21 and 4 p.m., Monday through Friday. an applicant may receive.
U.S.C. 355(i)) became effective: May 17, Dated: May 1, 2015. A regulatory review period consists of
2001. The applicant claims May 18, Leslie Kux, two periods of time: A testing phase and
2001, as the date the investigational new Associate Commissioner for Policy. an approval phase. For human drug
drug application (IND) became effective. products, the testing phase begins when
[FR Doc. 2015–11004 Filed 5–6–15; 8:45 am]
However, FDA records indicate that the the exemption to permit the clinical
BILLING CODE 4164–01–P
IND effective date was May 17, 2001, investigations of the drug becomes
which was 30 days after FDA receipt of effective and runs until the approval
the IND. phase begins. The approval phase starts
DEPARTMENT OF HEALTH AND
2. The date the application was HUMAN SERVICES with the initial submission of an
initially submitted with respect to the application to market the human drug
human drug product under section Food and Drug Administration product and continues until FDA grants
505(b) of the FD&C Act: September 8, permission to market the drug product.
2009. The applicant claims September [Docket Nos. FDA–2014–E–0070 and FDA–
2014–E–0071] Although only a portion of a regulatory
4, 2009, as the date the new drug review period may count toward the
application (NDA) for SYNRIBO was Determination of Regulatory Review actual amount of extension that the
initially submitted. However, FDA Period for Purposes of Patent Director of USPTO may award (for
records indicate that the NDA was Extension; GATTEX example, half the testing phase must be
submitted on September 8, 2009. subtracted as well as any time that may
3. The date the application was AGENCY: Food and Drug Administration, have occurred before the patent was
approved: October 26, 2012. FDA has HHS. issued), FDA’s determination of the
verified the applicant’s claim that the ACTION: Notice. length of a regulatory review period for
NDA for SYNRIBO was approved on a human drug product will include all
October 26, 2012. SUMMARY: The Food and Drug of the testing phase and approval phase
This determination of the regulatory Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B).
review period establishes the maximum the regulatory review period for FDA has approved for marketing the
potential length of a patent extension. GATTEX and is publishing this notice human drug product GATTEX
However, the USPTO applies several of that determination as required by (teduglutide [rDNA origin]). GATTEX is
statutory limitations in its calculations law. FDA has made the determination indicated for treatment of adult patients
of the actual period for patent extension. because of the submission of with Short Bowel Syndrome who are
In its application for patent extension, applications to the Director of the U.S. dependent on parenteral support.
this applicant seeks 1,217 days of patent Patent and Trademark Office (USPTO), Subsequent to this approval, the USPTO
term extension. Department of Commerce, for the received patent term restoration
Anyone with knowledge that any of extension of a patent which claims that applications for GATTEX (U.S. Patent
the dates as published are incorrect may human drug product. Nos. 5,789,379 and 7,056,886) from NPS
submit to the Division of Dockets ADDRESSES: Submit electronic Pharmaceuticals, Inc., and the USPTO
Management (see ADDRESSES) either comments to http:// requested FDA’s assistance in
electronic or written comments and ask www.regulations.gov. Submit written determining the patents’ eligibility for
for a redetermination by July 6, 2015. petitions (two copies are required) and patent term restoration. In a letter dated
Furthermore, any interested person may written comments to the Division of March 26, 2014, FDA advised the
petition FDA for a determination Dockets Management (HFA–305), Food USPTO that this human drug product
regarding whether the applicant for and Drug Administration, 5630 Fishers had undergone a regulatory review
Lane, Rm. 1061, Rockville, MD 20852.
mstockstill on DSK4VPTVN1PROD with NOTICES

extension acted with due diligence period and that the approval of
during the regulatory review period by Submit petitions electronically to GATTEX represented the first permitted
November 3, 2015. To meet its burden, http://www.regulations.gov at Docket commercial marketing or use of the
the petition must contain sufficient facts No. FDA–2013–S–0610. product. Thereafter, the USPTO
to merit an FDA investigation. (See H. FOR FURTHER INFORMATION CONTACT: requested that FDA determine the
Rept. 857, part 1, 98th Cong., 2d sess., Beverly Friedman, Office of product’s regulatory review period.
pp. 41–42, 1984.) Petitions should be in Management, Food and Drug FDA has determined that the
the format specified in 21 CFR 10.30. Administration, 10001 New Hampshire applicable regulatory review period for

VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Document Created: 2015-12-16 07:50:46
Document Modified: 2015-12-16 07:50:46

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 26271

80 FR 26271 - Determination of Regulatory Review Period for Purposes of Patent Extension; SYNRIBO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration