80 FR 26273 - Determination of Regulatory Review Period for Purposes of Patent Extension; COFLEX INTERLAMINAR TECHNOLOGY

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		26273-26274
FR Document		2015-10998

The Food and Drug Administration (FDA) has determined the regulatory review period for COFLEX INTERLAMINAR TECHNOLOGY 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. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

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

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26273-26274]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0296]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; COFLEX INTERLAMINAR TECHNOLOGY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for COFLEX INTERLAMINAR TECHNOLOGY 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. Patents and Trademarks Office (USPTO), 
Department of Commerce, for the extension of a patent which claims that 
medical device.

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, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180, 
Silver Spring, MD 20993-0002, 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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. Although only a portion of 
a regulatory review period may count toward the actual amount of 
extension that the Director of USPTO may award (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 medical device will include all of the 
testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA has approved for marketing the medical device COFLEX 
INTERLAMINAR TECHNOLOGY. COFLEX INTERLAMINAR TECHNOLOGY is indicated 
for use in one- or two-level lumbar stenosis from L1-L5 in skeletally 
mature patients with at least moderate impairment in function, who 
experience relief in flexion from their symptoms of leg/buttocks/groin 
pain, with or without back pain, and who have undergone at least 6 
months of non-operative treatment. Subsequent to this approval, USPTO 
received a patent term restoration application for COFLEX INTERLAMINAR 
TECHNOLOGY (U.S. Patent No. 5,645,599) from Paradigm Spine, LLC, and 
the USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated December 24, 
2013, FDA advised the USPTO that this medical device had undergone a 
regulatory review period and that the approval of COFLEX INTERLAMINAR 
TECHNOLOGY represented the first permitted commercial marketing or use 
of the product. Thereafter, the USPTO requested that the FDA determine 
the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
COFLEX INTERLAMINAR TECHNOLOGY is 2,382 days. Of this time, 1,787 days 
occurred during the testing phase of the regulatory review period, 
while 595 days occurred during the approval phase. These periods of 
time were derived from the following dates:

[[Page 26274]]

    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C act) (21 U.S.C. 360j(g)) involving 
this device became effective: April 12, 2006. The applicant claims that 
the investigational device exemption (IDE) required under section 
520(g) of the FD&C act for human tests to begin became effective on 
March 10, 2006. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
April 12, 2006, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March 3, 
2011. The applicant claims March 4, 2011, as the date the premarket 
approval application (PMA) for COFLEX INTERLAMINAR TECHNOLOGY (PMA 
P110008) was initially submitted. However, FDA records indicate that 
PMA P110008 was submitted on March 3, 2011.
    3. The date the application was approved: October 17, 2012. FDA has 
verified the applicant's claim that PMA P110008 was approved on October 
17, 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 1,503 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. 2015-10998 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

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:

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26274 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

1. The date an exemption under be submitted to http:// drug product, animal drug product,
section 520(g) of the Federal Food, Drug, www.regulations.gov, Docket No. FDA– medical device, food additive, or color
and Cosmetic Act (the FD&C act) (21 2013–S–0610. additive) was subject to regulatory
U.S.C. 360j(g)) involving this device Comments and petitions that have not review by FDA before the item was
became effective: April 12, 2006. The been made publicly available on marketed. Under these acts, a product’s
applicant claims that the investigational http://www.regulations.gov may be regulatory review period forms the basis
device exemption (IDE) required under viewed in the Division of Dockets for determining the amount of extension
section 520(g) of the FD&C act for Management between 9 a.m. and 4 p.m., an applicant may receive.
human tests to begin became effective Monday through Friday. A regulatory review period consists of
on March 10, 2006. However, FDA Dated: May 1, 2015. two periods of time: A testing phase and
records indicate that the IDE was Leslie Kux, an approval phase. For animal drug
determined substantially complete for products, the testing phase begins on
Associate Commissioner for Policy.
clinical studies to have begun on April the earlier date when either a major
12, 2006, which represents the IDE [FR Doc. 2015–10998 Filed 5–6–15; 8:45 am]
environmental effects test was initiated
effective date. BILLING CODE 4164–01–P
for the drug or when an exemption
2. The date an application was under section 512(j) of the Federal Food,
initially submitted with respect to the Drug, and Cosmetic Act (the FD&C Act)
device under section 515 of the FD&C DEPARTMENT OF HEALTH AND
HUMAN SERVICES (21 U.S.C. 360b(j)) became effective and
Act (21 U.S.C. 360e): March 3, 2011. runs until the approval phase begins.
The applicant claims March 4, 2011, as The approval phase starts with the
Food and Drug Administration
the date the premarket approval initial submission of an application to
application (PMA) for COFLEX [Docket Nos. FDA–2013–E–0968 and FDA– market the animal drug product and
INTERLAMINAR TECHNOLOGY (PMA 2013–E–0969]
continues until FDA grants permission
P110008) was initially submitted. to market the drug product. Although
However, FDA records indicate that Determination of Regulatory Review
Period for Purposes of Patent only a portion of a regulatory review
PMA P110008 was submitted on March period may count toward the actual
3, 2011. Extension; OVUGEL
amount of extension that the Director
3. The date the application was AGENCY: Food and Drug Administration, USPTO may award (for example, half
approved: October 17, 2012. FDA has HHS. the testing phase must be subtracted as
verified the applicant’s claim that PMA
ACTION: Notice. well as any time that may have occurred
P110008 was approved on October 17,
before the patent was issued), FDA’s
2012. SUMMARY: The Food and Drug
This determination of the regulatory determination of the length of a
Administration (FDA) has determined regulatory review period for an animal
review period establishes the maximum the regulatory review period for
potential length of a patent extension. drug product will include all of the
OVUGEL and is publishing this notice testing phase and approval phase as
However, the USPTO applies several of that determination as required by
statutory limitations in its calculations specified in 35 U.S.C. 156(g)(4)(B).
law. FDA has made the determination FDA has approved for marketing the
of the actual period for patent extension. because of the submission of
In its application for patent extension, animal drug product OVUGEL
applications to the Director of U.S. (triptorelin acetate). OVUGEL, an
this applicant seeks 1,503 days of patent Patents and Trademarks Office
term extension. animal drug product, is indicated for the
(USPTO), Department of Commerce, for synchronization of time of insemination
Anyone with knowledge that any of the extension of a patent which claims
the dates as published are incorrect may in weaned sows to facilitate a single
that animal drug product. fixed-time artificial insemination.
submit to the Division of Dockets
ADDRESSES: Submit electronic Subsequent to this approval, the USPTO
Management (see ADDRESSES) either
electronic or written comments and ask comments to http:// received patent term restoration
for a redetermination by July 6, 2015. www.regulations.gov. Submit written applications for OVUGEL (U.S. Patent
Furthermore, any interested person may petitions (two copies are required) and Nos. 5,985,320 and RE 42,072) from
petition FDA for a determination written comments to the Division of Penn State Research Foundation and
regarding whether the applicant for Dockets Management (HFA–305), Food Massachusetts Institute of Technology,
extension acted with due diligence and Drug Administration, 5630 Fishers and the USPTO requested FDA’s
during the regulatory review period by Lane, Rm. 1061, Rockville, MD 20852. assistance in determining the patents’
November 3, 2015. To meet its burden, Submit petitions electronically to eligibility for patent term restoration. In
the petition must contain sufficient facts http://www.regulations.gov at Docket a letter dated March 25, 2014, FDA
to merit an FDA investigation. (See H. No. FDA–2013–S–0610. advised the Patent and Trademark
Rept. 857, part 1, 98th Cong., 2d sess., FOR FURTHER INFORMATION CONTACT: Office that this animal drug product had
pp. 41–42, 1984.) Petitions should be in Beverly Friedman, Office of undergone a regulatory review period
the format specified in 21 CFR 10.30. Management, Food and Drug and that the approval of OVUGEL
Interested persons may submit to the Administration, 10001 New Hampshire represented the first permitted
Division of Dockets Management (see Ave., Hillandale Bldg., Rm. 3180, Silver commercial marketing or use of the
ADDRESSES) electronic or written Spring, MD 20993–0002, 301–796–7900. product. Thereafter, the USPTO
requested that the FDA determine the
mstockstill on DSK4VPTVN1PROD with NOTICES

comments and written or electronic SUPPLEMENTARY INFORMATION: The Drug
petitions. It is only necessary to send Price Competition and Patent Term product’s regulatory review period.
one set of comments. Identify comments Restoration Act of 1984 (Pub. L. 98–417) FDA has determined that the
with the docket number found in and the Generic Animal Drug and Patent applicable regulatory review period for
brackets in the heading of this Term Restoration Act (Pub. L. 100–670) OVUGEL is 3,692 days. Of this time,
document. If you submit a written generally provide that a patent may be 3,644 days occurred during the testing
petition, two copies are required. A extended for a period of up to 5 years phase of the regulatory review period,
petition submitted electronically must so long as the patented item (human while 48 days occurred during the

VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Document Created: 2015-12-16 07:50:42
Document Modified: 2015-12-16 07:50:42

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, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180, Silver Spring, MD 20993-0002, 301-796-7900.
FR Citation		80 FR 26273

80 FR 26273 - Determination of Regulatory Review Period for Purposes of Patent Extension; COFLEX INTERLAMINAR TECHNOLOGY

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