Determination of Regulatory Review Period for Purposes of Patent Extension; Xience Prime Ll Everolimus Eluting Coronary Stent System, 33199-33200 [2014-13445]
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emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
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
https://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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
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 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 STENDRA
(avanafil). STENDRA is indicated for the
treatment of erectile dysfunction.
Subsequent to this approval, USPTO
received a patent term restoration
application for STENDRA (U.S. Patent
No. 6,656,935) from Mitsubishi Tanabe
Pharma Corp., and USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
VerDate Mar<15>2010
16:55 Jun 09, 2014
Jkt 232001
restoration. In a letter dated February
13, 2013, FDA advised USPTO that this
human drug product had undergone a
regulatory review period and that the
approval of STENDRA represented the
first permitted commercial marketing or
use of the product. Thereafter, USPTO
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
STENDRA is 3,770 days. Of this time,
3,466 days occurred during the testing
phase of the regulatory review period,
while 304 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: January
2, 2002. FDA has verified the
applicant’s claim that the date the
investigational new drug application
became effective was on January 2,
2002.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: June 29, 2011.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
STENDRA (NDA 202276) was submitted
on June 29, 2011.
3. The date the application was
approved: April 27, 2012. FDA has
verified the applicant’s claim that NDA
202276 was approved on April 27, 2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,686 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 August 11,
2014. 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 8, 2014. 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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
33199
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 https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13444 Filed 6–9–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–1241]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Xience Prime Ll Everolimus
Eluting Coronary Stent System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for Xience
Prime Ll Everolimus Eluting Coronary
Stent System 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 medical
device.
ADDRESSES: Submit electronic
comments to https://
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
https://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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
emcdonald on DSK67QTVN1PROD with NOTICES
33200
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
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 Xience Prime Ll
Everolimus Eluting Coronary Stent
System. Xience Prime Ll Everolimus
Eluting Coronary Stent System is
indicated for improving coronary
luminal diameter in patients with
symptomatic heart disease due to de
novo native coronary artery lesions
(length ≤ 32 millimeters (mm)) with
reference vessel diameters of ≥2.25 mm
to ≤ 4.25 mm. Subsequent to this
approval, the USPTO received a patent
term restoration application for Xience
Prime Ll Everolimus Eluting Coronary
Stent System (U.S. Patent No. 5,514,154)
from Abbott Cardiovascular Systems
Inc., and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 4, 2013, FDA
advised the USPTO that this medical
device had undergone a regulatory
review period and that the approval of
Xience Prime Ll Everolimus Eluting
Coronary Stent System represented the
first permitted commercial marketing or
use of the product. Thereafter, the
VerDate Mar<15>2010
16:55 Jun 09, 2014
Jkt 232001
USPTO requested that the FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
Xience Prime Ll Everolimus Eluting
Coronary Stent System is 890 days. Of
this time, 694 days occurred during the
testing phase of the regulatory review
period, while 196 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
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: May 27, 2009. FDA
has verified the applicant’s claim that
the date the investigational device
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective May 27, 2009.
2. The date an application was
initially submitted with respect to the
device under section 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360e): April 20, 2011. The applicant
claims October 28, 2010, as the date the
premarket approval application (PMA)
for Xience Prime Ll Everolimus Eluting
Coronary Stent System (PMA P110019)
was initially submitted. However, FDA
records indicate that PMA P110019 was
submitted in full on April 20, 2011.
3. The date the application was
approved: November 1, 2011. FDA has
verified the applicant’s claim that PMA
P110019 was approved on November 1,
2011.
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 630 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 August 11,
2014. 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 8, 2014. 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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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 https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13445 Filed 6–9–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2001–D–0067 (Formerly
Docket No. 2001D–0185)]
Draft Guidance for Industry on
Providing Submissions in Electronic
Format—Postmarketing Safety
Reports; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Providing
Submissions in Electronic Format—
Postmarketing Safety Reports.’’ This
draft guidance provides general
information pertaining to electronic
submission of postmarketing safety
reports (individual case safety reports
(ICSRs), attachments to ICSRs (ICSR
attachments), and other postmarketing
safety reports) for certain human drug
and biological products. We are issuing
the draft guidance to help persons
required to submit postmarketing safety
reports comply with the final rule.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 11,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33199-33200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-E-1241]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Xience Prime Ll Everolimus Eluting Coronary Stent System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for Xience Prime Ll Everolimus Eluting
Coronary Stent System 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 medical device.
ADDRESSES: Submit electronic comments to https://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 https://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, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257,
[[Page 33200]]
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 Xience Prime Ll
Everolimus Eluting Coronary Stent System. Xience Prime Ll Everolimus
Eluting Coronary Stent System is indicated for improving coronary
luminal diameter in patients with symptomatic heart disease due to de
novo native coronary artery lesions (length <= 32 millimeters (mm))
with reference vessel diameters of >=2.25 mm to <= 4.25 mm. Subsequent
to this approval, the USPTO received a patent term restoration
application for Xience Prime Ll Everolimus Eluting Coronary Stent
System (U.S. Patent No. 5,514,154) from Abbott Cardiovascular Systems
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
March 4, 2013, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of Xience
Prime Ll Everolimus Eluting Coronary Stent System 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
Xience Prime Ll Everolimus Eluting Coronary Stent System is 890 days.
Of this time, 694 days occurred during the testing phase of the
regulatory review period, while 196 days occurred during the approval
phase. These periods of time were derived from the following dates:
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: May 27, 2009. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective May 27, 2009.
2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): April 20, 2011. The applicant claims October 28,
2010, as the date the premarket approval application (PMA) for Xience
Prime Ll Everolimus Eluting Coronary Stent System (PMA P110019) was
initially submitted. However, FDA records indicate that PMA P110019 was
submitted in full on April 20, 2011.
3. The date the application was approved: November 1, 2011. FDA has
verified the applicant's claim that PMA P110019 was approved on
November 1, 2011.
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 630 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 August 11, 2014. 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 8, 2014. 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
https://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13445 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P
