80 FR 26274 - Determination of Regulatory Review Period for Purposes of Patent Extension; OVUGEL

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		26274-26275
FR Document		2015-11003

The Food and Drug Administration (FDA) has determined the regulatory review period for OVUGEL 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 U.S. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

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

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26274-26275]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0968 and FDA-2013-E-0969]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for OVUGEL 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 U.S. 
Patents and Trademarks Office (USPTO), Department of Commerce, for the 
extension of a patent which claims that animal 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 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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the animal 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 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 an animal 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product OVUGEL 
(triptorelin acetate). OVUGEL, an animal drug product, is indicated for 
the synchronization of time of insemination in weaned sows to 
facilitate a single fixed-time artificial insemination. Subsequent to 
this approval, the USPTO received patent term restoration applications 
for OVUGEL (U.S. Patent Nos. 5,985,320 and RE 42,072) from Penn State 
Research Foundation and Massachusetts Institute of Technology, and the 
USPTO requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated March 25, 
2014, FDA advised the Patent and Trademark Office that this animal drug 
product had undergone a regulatory review period and that the approval 
of OVUGEL 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 
OVUGEL is 3,692 days. Of this time, 3,644 days occurred during the 
testing phase of the regulatory review period, while 48 days occurred 
during the

[[Page 26275]]

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: August 12, 2002. The applicant claims February 13, 2002, as 
the date the investigational new animal drug application (INAD) became 
effective. However, FDA records indicate that the INAD effective date 
was August 12, 2002, which was the date a major health or environmental 
effects test is begun or the date on which the Agency acknowledges the 
filing of a notice of claimed investigational exemption for a new 
animal drug, whichever is earlier.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act (21 U.S.C. 
360b): August 2, 2012. The applicant claims July 20, 2012, as the date 
the new animal drug Application (NADA) for OVUGEL RE42072 (NADA 141-
339) was initially submitted. However, FDA records indicate that NADA 
141-339 was submitted on August 2, 2012.
    3. The date the application was approved: September 18, 2012. FDA 
has verified the applicant's claim that NADA 141-339 was approved on 
September 18, 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 331 or 1,826 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. 2015-11003 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P

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

Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26275

approval phase. These periods of time petition, two copies are required. A and the Generic Animal Drug and Patent
were derived from the following dates: petition submitted electronically must Term Restoration Act (Pub. L. 100–670)
1. The date an exemption under be submitted to http:// generally provide that a patent may be
section 505(i) of the Federal Food, Drug, www.regulations.gov, Docket No. FDA– extended for a period of up to 5 years
and Cosmetic Act (the FD&C Act) (21 2013–S–0610. so long as the patented item (human
U.S.C. 355(i)) became effective: August Comments and petitions that have not drug product, animal drug product,
12, 2002. The applicant claims February been made publicly available on medical device, food additive, or color
13, 2002, as the date the investigational http://www.regulations.gov may be additive) was subject to regulatory
new animal drug application (INAD) viewed in the Division of Dockets review by FDA before the item was
became effective. However, FDA records Management between 9 a.m. and 4 p.m., marketed. Under these acts, a product’s
indicate that the INAD effective date Monday through Friday. regulatory review period forms the basis
was August 12, 2002, which was the for determining the amount of extension
Dated: May 1, 2015.
date a major health or environmental an applicant may receive.
effects test is begun or the date on Leslie Kux, A regulatory review period consists of
which the Agency acknowledges the Associate Commissioner for Policy. two periods of time: A testing phase and
filing of a notice of claimed [FR Doc. 2015–11003 Filed 5–6–15; 8:45 am] an approval phase. For medical devices,
investigational exemption for a new BILLING CODE 4164–01–P the testing phase begins with a clinical
animal drug, whichever is earlier. investigation of the device and runs
2. The date the application was until the approval phase begins. The
initially submitted with respect to the DEPARTMENT OF HEALTH AND approval phase starts with the initial
animal drug product under section 512 HUMAN SERVICES submission of an application to market
of the FD&C Act (21 U.S.C. 360b): the device and continues until
August 2, 2012. The applicant claims Food and Drug Administration permission to market the device is
July 20, 2012, as the date the new [Docket No. FDA–2013–E–1652] granted. Although only a portion of a
animal drug Application (NADA) for regulatory review period may count
OVUGEL RE42072 (NADA 141–339) Determination of Regulatory Review toward the actual amount of extension
was initially submitted. However, FDA Period for Purposes of Patent that the Director of USPTO may award
records indicate that NADA 141–339 Extension; HVAD ROTARY BLOOD (half the testing phase must be
was submitted on August 2, 2012. PUMP subtracted as well as any time that may
3. The date the application was have occurred before the patent was
approved: September 18, 2012. FDA has AGENCY: Food and Drug Administration, issued), FDA’s determination of the
verified the applicant’s claim that HHS. length of a regulatory review period for
NADA 141–339 was approved on ACTION: Notice. a medical device will include all of the
September 18, 2012. testing phase and approval phase as
This determination of the regulatory SUMMARY: The Food and Drug specified in 35 U.S.C. 156(g)(3)(B).
review period establishes the maximum Administration (FDA) has determined FDA has approved for marketing the
potential length of a patent extension. the regulatory review period for HVAD medical device HVAD ROTARY BLOOD
However, the USPTO applies several ROTARY BLOOD PUMP and is PUMP. HVAD ROTARY BLOOD PUMP
statutory limitations in its calculations publishing this notice of that is indicated for use as a bridge to
of the actual period for patent extension. determination as required by law. FDA cardiac transplantation in patients who
In its applications for patent extension, has made the determination because of are at risk of death from refractory end-
this applicant seeks 331 or 1,826 days the submission of an application to the stage left ventricular heart failure.
of patent term extension. Director of the U.S. Patent and Subsequent to this approval, the USPTO
Anyone with knowledge that any of Trademark Office (USPTO), Department received a patent term restoration
the dates as published are incorrect may of Commerce, for the extension of a application for HVAD ROTARY BLOOD
submit to the Division of Dockets patent which claims that medical PUMP (U.S. Patent No. 6,234,772) from
Management (see ADDRESSES) either device. HeartWare, Inc., and the USPTO
electronic or written comments and ask ADDRESSES: Submit electronic requested FDA’s assistance in
for a redetermination by July 6, 2015. comments to http:// determining this patent’s eligibility for
Furthermore, any interested person may www.regulations.gov. Submit written patent term restoration. In a letter dated
petition FDA for a determination petitions (two copies are required) and March 18, 2014, FDA advised the
regarding whether the applicant for written comments to the Division of USPTO that this medical device had
extension acted with due diligence Dockets Management (HFA–305), Food undergone a regulatory review period
during the regulatory review period by and Drug Administration, 5630 Fishers and that the approval of HVAD
November 3, 2015. To meet its burden, Lane, Rm. 1061, Rockville, MD 20852. ROTARY BLOOD PUMP represented
the petition must contain sufficient facts Submit petitions electronically to the first permitted commercial
to merit an FDA investigation. (See H. http://www.regulations.gov at Docket marketing or use of the product.
Rept. 857, part 1, 98th Cong., 2d sess., No. FDA–2013–S–0610. Thereafter, the USPTO requested that
pp. 41–42, 1984.) Petitions should be in FDA determine the product’s regulatory
FOR FURTHER INFORMATION CONTACT:
the format specified in 21 CFR 10.30. review period.
Interested persons may submit to the Beverly Friedman, Office of FDA has determined that the
Management, Food and Drug
mstockstill on DSK4VPTVN1PROD with NOTICES

Division of Dockets Management (see applicable regulatory review period for
ADDRESSES) electronic or written
Administration, 10001 New Hampshire HVAD ROTARY BLOOD PUMP is 1,667
comments and written or electronic Ave., Hillandale Campus, Rm. 3180, days. Of this time, 973 days occurred
petitions. It is only necessary to send Silver Spring, MD 20993, 301–796– during the testing phase of the
one set of comments. Identify comments 7900. regulatory review period, while 694
with the docket number found in SUPPLEMENTARY INFORMATION: The Drug days occurred during the approval
brackets in the heading of this Price Competition and Patent Term phase. These periods of time were
document. If you submit a written Restoration Act of 1984 (Pub. L. 98–417) derived from the following dates:

VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Document Created: 2015-12-16 07:50:49
Document Modified: 2015-12-16 07:50:49

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 Bldg., Rm. 3180, Silver Spring, MD 20993-0002, 301-796-7900.
FR Citation		80 FR 26274

80 FR 26274 - Determination of Regulatory Review Period for Purposes of Patent Extension; OVUGEL

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