80 FR 26272 - Determination of Regulatory Review Period for Purposes of Patent Extension; GATTEX

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		26272-26273
FR Document		2015-11000

The Food and Drug Administration (FDA) has determined the regulatory review period for GATTEX 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 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26272-26273]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-11000]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-0070 and FDA-2014-E-0071]

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

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 GATTEX 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.

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 GATTEX
(teduglutide [rDNA origin]). GATTEX is indicated for treatment of adult
patients with Short Bowel Syndrome who are dependent on parenteral
support. Subsequent to this approval, the USPTO received patent term
restoration applications for GATTEX (U.S. Patent Nos. 5,789,379 and
7,056,886) from NPS Pharmaceuticals, Inc., and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated March 26, 2014, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of GATTEX 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

[[Page 26273]]

GATTEX is 4,959 days. Of this time, 4,571 days occurred during the
testing phase of the regulatory review period, while 388 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 27, 1999. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on May 27, 1999.
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
30, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for GATTEX (NDA 203441) was submitted on November 30,
2011.
3. The date the application was approved: December 21, 2012. FDA
has verified the applicant's claim that NDA 203441 was approved on
December 21, 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 applications for patent extension,
this applicant seeks 1,388 days or 5 years 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. 2015-11000 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

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

Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26273

GATTEX is 4,959 days. Of this time, may be viewed in the Division of additive) was subject to regulatory
4,571 days occurred during the testing Dockets Management between 9 a.m. review by FDA before the item was
phase of the regulatory review period, and 4 p.m., Monday through Friday. marketed. Under these acts, a product’s
while 388 days occurred during the Dated: May 1, 2015. regulatory review period forms the basis
approval phase. These periods of time Leslie Kux,
for determining the amount of extension
were derived from the following dates: an applicant may receive.
1. The date an exemption under Associate Commissioner for Policy. A regulatory review period consists of
section 505(i) of the Federal Food, Drug, [FR Doc. 2015–11000 Filed 5–6–15; 8:45 am] two periods of time: A testing phase and
and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P an approval phase. For medical devices,
U.S.C. 355(i)) became effective: May 27, the testing phase begins with a clinical
1999. FDA has verified the applicant’s investigation of the device and runs
claim that the date the investigational DEPARTMENT OF HEALTH AND until the approval phase begins. The
new drug application became effective HUMAN SERVICES approval phase starts with the initial
was on May 27, 1999. submission of an application to market
2. The date the application was Food and Drug Administration
the device and continues until
initially submitted with respect to the [Docket No. FDA–2013–E–0296] permission to market the device is
human drug product under section granted. Although only a portion of a
505(b) of the FD&C Act: November 30, Determination of Regulatory Review regulatory review period may count
2011. FDA has verified the applicant’s Period for Purposes of Patent toward the actual amount of extension
claim that the new drug application Extension; COFLEX INTERLAMINAR that the Director of USPTO may award
(NDA) for GATTEX (NDA 203441) was TECHNOLOGY (half the testing phase must be
submitted on November 30, 2011. AGENCY: Food and Drug Administration, subtracted as well as any time that may
3. The date the application was have occurred before the patent was
HHS.
approved: December 21, 2012. FDA has issued), FDA’s determination of the
verified the applicant’s claim that NDA ACTION: Notice.
length of a regulatory review period for
203441 was approved on December 21, SUMMARY: The Food and Drug a medical device will include all of the
2012. Administration (FDA) has determined testing phase and approval phase as
This determination of the regulatory the regulatory review period for specified in 35 U.S.C. 156(g)(3)(B).
review period establishes the maximum COFLEX INTERLAMINAR FDA has approved for marketing the
potential length of a patent extension. TECHNOLOGY and is publishing this medical device COFLEX
However, the USPTO applies several notice of that determination as required INTERLAMINAR TECHNOLOGY.
statutory limitations in its calculations by law. FDA has made the COFLEX INTERLAMINAR
of the actual period for patent extension. determination because of the TECHNOLOGY is indicated for use in
In its applications for patent extension, submission of an application to the one- or two-level lumbar stenosis from
this applicant seeks 1,388 days or 5 L1–L5 in skeletally mature patients with
Director of the U.S. Patents and
years of patent term extension. at least moderate impairment in
Trademarks Office (USPTO),
Anyone with knowledge that any of function, who experience relief in
the dates as published are incorrect may Department of Commerce, for the
extension of a patent which claims that flexion from their symptoms of leg/
submit to the Division of Dockets buttocks/groin pain, with or without
Management (see ADDRESSES) either medical device.
back pain, and who have undergone at
electronic or written comments and ask ADDRESSES: Submit electronic
least 6 months of non-operative
for a redetermination by July 6, 2015. comments to http://
treatment. Subsequent to this approval,
Furthermore, any interested person may www.regulations.gov. Submit written
USPTO received a patent term
petition FDA for a determination petitions (two copies are required) and
restoration application for COFLEX
regarding whether the applicant for written comments to the Division of
INTERLAMINAR TECHNOLOGY (U.S.
extension acted with due diligence Dockets Management (HFA–305), Food Patent No. 5,645,599) from Paradigm
during the regulatory review period by and Drug Administration, 5630 Fishers Spine, LLC, and the USPTO requested
November 3, 2015. To meet its burden, Lane, Rm. 1061, Rockville, MD 20852. FDA’s assistance in determining this
the petition must contain sufficient facts Submit petitions electronically to patent’s eligibility for patent term
to merit an FDA investigation. (See H. http://www.regulations.gov at Docket restoration. In a letter dated December
Rept. 857, part 1, 98th Cong., 2d sess., No. FDA–2013–S–0610. 24, 2013, FDA advised the USPTO that
pp. 41–42, 1984.) Petitions should be in FOR FURTHER INFORMATION CONTACT: this medical device had undergone a
the format specified in 21 CFR 10.30. Beverly Friedman, Office of regulatory review period and that the
Interested persons may submit to the Management, Center for Drug approval of COFLEX INTERLAMINAR
Division of Dockets Management (see Evaluation and Research, Food and TECHNOLOGY represented the first
ADDRESSES) electronic or written Drug Administration, 10001 New permitted commercial marketing or use
comments and written or electronic Hampshire Ave., Hillandale Bldg., Rm. of the product. Thereafter, the USPTO
petitions. It is only necessary to send 3180, Silver Spring, MD 20993–0002, requested that the FDA determine the
one set of comments. Identify comments 301–796–7900. product’s regulatory review period.
with the docket number found in SUPPLEMENTARY INFORMATION: The Drug FDA has determined that the
brackets in the heading of this Price Competition and Patent Term applicable regulatory review period for
mstockstill on DSK4VPTVN1PROD with NOTICES

document. If you submit a written Restoration Act of 1984 (Pub. L. 98–417) COFLEX INTERLAMINAR
petition, two copies are required. A and the Generic Animal Drug and Patent TECHNOLOGY is 2,382 days. Of this
petition submitted electronically must Term Restoration Act (Pub. L. 100–670) time, 1,787 days occurred during the
be submitted to http:// generally provide that a patent may be testing phase of the regulatory review
www.regulations.gov, Docket No. FDA– extended for a period of up to 5 years period, while 595 days occurred during
2013–S–0610. Comments and petitions so long as the patented item (human the approval phase. These periods of
that have not been made publicly drug product, animal drug product, time were derived from the following
available on http://www.regulations.gov medical device, food additive, or color dates:

VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Document Created: 2015-12-16 07:50:36
Document Modified: 2015-12-16 07:50:36

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 26272

80 FR 26272 - Determination of Regulatory Review Period for Purposes of Patent Extension; GATTEX

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