Determination of Regulatory Review Period for Purposes of Patent Extension; EYLEA, 18566-18567 [2014-07333]
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tkelley on DSK3SPTVN1PROD with NOTICES
18566
Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices
https://www.regulations.govat 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. 6284,
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 Patents and Trademarks 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 recently approved for marketing
the human drug product FIRAZYR
(icatibant acetate). FIRAZYR is
indicated for treatment of acute attacks
of hereditary angioedema in adults 18
years of age and older. Subsequent to
this approval, the U.S. Patent and
Trademark Office received a patent term
restoration application for FIRAZYR
(U.S. Patent No. 5,648,333) from SanofiAventis Deutschland GmbH, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated July 10,
2012, FDA advised the Patent and
Trademark Office that this human drug
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17:01 Apr 01, 2014
Jkt 232001
product had undergone a regulatory
review period and that the approval of
FIRAZYR represented the first
permitted commercial marketing or use
of the product. Thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
FIRAZYR is 2,663 days. Of this time,
1,263 days occurred during the testing
phase of the regulatory review period,
while 1,400 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 12,
2004. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on May 12, 2004.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: October 26,
2007. FDA has verified the applicant’s
claim that the new drug application
(NDA) for FIRAZYR (NDA 22–150) was
submitted on October 26, 2007.
3. The date the application was
approved: August 25, 2011. FDA has
verified the applicant’s claim that NDA
22–150 was approved on August 25,
2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the Patent and Trademark
Office applies several statutory
limitations in its calculations of the
actual period for patent extension. In its
application for patent extension, this
applicant seeks 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 June 2, 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
September 29, 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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07331 Filed 4–1–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–E–0487; FDA–
2012–E–0488; and FDA–2012–E–0489]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EYLEA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for EYLEA
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 Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human biological product.
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. 6284,
Silver Spring, MD 20993–0002, 301–
796–3602.
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices
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 Patents and Trademarks 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 biological product EYLEA
(aflibercept). EYLEA is indicated for the
treatment of patients with neovascular
(Wet) Age-Related Macular
Degeneration (AMD). Subsequent to this
approval, the U.S. Patent and
Trademark Office received patent term
restoration applications for EYLEA (U.S.
Patent Nos.: 7,070,959; 7,374,757; and
7,374,758) from Regeneron
Pharmaceuticals, Inc., and the Patent
and Trademark Office requested FDA’s
assistance in determining these patents’
eligibility for patent term restoration. In
a letter dated August 7, 2012, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of EYLEA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:35 Apr 01, 2014
Jkt 232001
EYLEA is 2,349 days. Of this time, 2,075
days occurred during the testing phase
of the regulatory review period, while
274 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: June 15,
2005. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on June 15, 2005.
2. The date the application was
initially submitted with respect to the
human drug product under section 352
of the Public Health Service Act (42
U.S.C. 262): February 18, 2011. The
applicant claims February 17, 2011, as
the date the biologics license
application (BLA) for EYLEA (BLA
125387/0) was initially submitted.
However, FDA records indicate that
BLA 125387/0 was submitted on
February 18, 2011.
3. The date the application was
approved: November 18, 2011. FDA has
verified the applicant’s claim that BLA
125387/0 was approved on November
18, 2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the Patent and Trademark
Office applies several statutory
limitations in its calculations of the
actual period for patent extension. In its
applications for patent extension, this
applicant seeks either 775 or 1,118 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 June 2, 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
September 29, 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 electronic or written
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
18567
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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07333 Filed 4–1–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–E–0716]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NOVOTFF–100A SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NOVOTFF–100A 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 Patents and Trademarks,
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,
Silver Spring, MD 20993–0002, 301–
796–3602.
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
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
Agencies
[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18566-18567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07333]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-E-0487; FDA-2012-E-0488; and FDA-2012-E-0489]
Determination of Regulatory Review Period for Purposes of Patent
Extension; EYLEA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for EYLEA 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.
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. 6284, Silver
Spring, MD 20993-0002, 301-796-3602.
[[Page 18567]]
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 Patents and
Trademarks 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 biological product EYLEA
(aflibercept). EYLEA is indicated for the treatment of patients with
neovascular (Wet) Age-Related Macular Degeneration (AMD). Subsequent to
this approval, the U.S. Patent and Trademark Office received patent
term restoration applications for EYLEA (U.S. Patent Nos.: 7,070,959;
7,374,757; and 7,374,758) from Regeneron Pharmaceuticals, Inc., and the
Patent and Trademark Office requested FDA's assistance in determining
these patents' eligibility for patent term restoration. In a letter
dated August 7, 2012, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of EYLEA represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
FDA has determined that the applicable regulatory review period for
EYLEA is 2,349 days. Of this time, 2,075 days occurred during the
testing phase of the regulatory review period, while 274 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: June 15, 2005. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on June 15, 2005.
2. The date the application was initially submitted with respect to
the human drug product under section 352 of the Public Health Service
Act (42 U.S.C. 262): February 18, 2011. The applicant claims February
17, 2011, as the date the biologics license application (BLA) for EYLEA
(BLA 125387/0) was initially submitted. However, FDA records indicate
that BLA 125387/0 was submitted on February 18, 2011.
3. The date the application was approved: November 18, 2011. FDA
has verified the applicant's claim that BLA 125387/0 was approved on
November 18, 2011.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks either 775 or
1,118 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 June 2, 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 September 29, 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 electronic or
written 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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07333 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P