83 FR 6858 - Determination of Regulatory Review Period for Purposes of Patent Extension; AVEED

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

Page Range		6858-6859
FR Document		2018-03136

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AVEED 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 human drug product.

Federal Register, Volume 83 Issue 32 (Thursday, February 15, 2018)

[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6858-6859]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-03136]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-1179]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for AVEED 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 human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. 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 August 14, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-E-1179 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; AVEED.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

[[Page 6859]]

SUPPLEMENTARY INFORMATION:

I. Background

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 AVEED
(testosterone undecanoate). AVEED is indicated for testosterone
replacement therapy in adult males for the following conditions that
are associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired)
Hypogonadotropic hypogonadism (congenital or acquired)

Subsequent to this approval, the USPTO received a patent term
restoration application for AVEED (U.S. Patent No. 8,338,395) from
Bayer Intellectual Property GmbH, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated November 2, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of AVEED represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
AVEED is 2,923 days. Of this time, 541 days occurred during the testing
phase of the regulatory review period, while 2,382 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
March 6, 2006. The applicant claims March 3, 2006, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was March 6, 2006,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: August 28,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) for AVEED (NDA 022219) was initially submitted on
August 28, 2007.
3. The date the application was approved: March 5, 2014. FDA has
verified the applicant's claim that NDA 022219 was approved on March 5,
2014.
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 435 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03136 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6859

SUPPLEMENTARY INFORMATION: commercial marketing or use of the applicant. (See H. Rept. 857, part 1, 98th
product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.)
I. Background
requested that FDA determine the Petitions should be in the format
The Drug Price Competition and product’s regulatory review period. specified in 21 CFR 10.30.
Patent Term Restoration Act of 1984 Submit petitions electronically to
(Pub. L. 98–417) and the Generic II. Determination of Regulatory Review
https://www.regulations.gov at Docket
Animal Drug and Patent Term Period
No. FDA–2013–S–0610. Submit written
Restoration Act (Pub. L. 100–670) FDA has determined that the petitions (two copies are required) to the
generally provide that a patent may be applicable regulatory review period for Dockets Management Staff (HFA–305),
extended for a period of up to 5 years AVEED is 2,923 days. Of this time, 541 Food and Drug Administration, 5630
so long as the patented item (human days occurred during the testing phase Fishers Lane, Rm. 1061, Rockville, MD
drug product, animal drug product, of the regulatory review period, while 20852.
medical device, food additive, or color 2,382 days occurred during the approval
Dated: February 9, 2018.
additive) was subject to regulatory phase. These periods of time were
Leslie Kux,
review by FDA before the item was derived from the following dates:
1. The date an exemption under Associate Commissioner for Policy.
marketed. Under these acts, a product’s
regulatory review period forms the basis section 505(i) of the Federal Food, Drug, [FR Doc. 2018–03136 Filed 2–14–18; 8:45 am]
for determining the amount of extension and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P

an applicant may receive. 355(i)) became effective: March 6, 2006.
A regulatory review period consists of The applicant claims March 3, 2006, as
two periods of time: A testing phase and the date the investigational new drug DEPARTMENT OF HEALTH AND
an approval phase. For human drug application (IND) became effective. HUMAN SERVICES
products, the testing phase begins when However, FDA records indicate that the
IND effective date was March 6, 2006, Food and Drug Administration
the exemption to permit the clinical
investigations of the drug becomes which was 30 days after FDA receipt of [Docket No. FDA–2014–E–2326]
effective and runs until the approval the IND.
phase begins. The approval phase starts 2. The date the application was Determination of Regulatory Review
with the initial submission of an initially submitted with respect to the Period for Purposes of Patent
application to market the human drug human drug product under section Extension; FETZIMA
product and continues until FDA grants 505(b) of the FD&C Act: August 28, AGENCY: Food and Drug Administration,
permission to market the drug product. 2007. FDA has verified the applicant’s HHS.
Although only a portion of a regulatory claim that the new drug application
(NDA) for AVEED (NDA 022219) was ACTION: Notice.
review period may count toward the
actual amount of extension that the initially submitted on August 28, 2007. SUMMARY: The Food and Drug
Director of USPTO may award (for 3. The date the application was Administration (FDA or the Agency) has
example, half the testing phase must be approved: March 5, 2014. FDA has determined the regulatory review period
subtracted as well as any time that may verified the applicant’s claim that NDA for FETZIMA and is publishing this
have occurred before the patent was 022219 was approved on March 5, 2014. notice of that determination as required
This determination of the regulatory by law. FDA has made the
issued), FDA’s determination of the
review period establishes the maximum determination because of the
length of a regulatory review period for
potential length of a patent extension. submission of an application to the
a human drug product will include all
However, the USPTO applies several Director of the U.S. Patent and
of the testing phase and approval phase
statutory limitations in its calculations Trademark Office (USPTO), Department
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the of the actual period for patent extension. of Commerce, for the extension of a
human drug product AVEED In its application for patent extension, patent which claims that human drug
(testosterone undecanoate). AVEED is this applicant seeks 435 days of patent product.
indicated for testosterone replacement term extension.
DATES: Anyone with knowledge that any
therapy in adult males for the following III. Petitions of the dates as published (in the
conditions that are associated with a Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are
deficiency or absence of endogenous the dates as published are incorrect may incorrect may submit either electronic
testosterone: submit either electronic or written or written comments and ask for a
• Primary hypogonadism (congenital or comments and, under 21 CFR 60.24, ask redetermination by April 16, 2018.
acquired) for a redetermination (see DATES). Furthermore, any interested person may
• Hypogonadotropic hypogonadism Furthermore, as specified in § 60.30 (21 petition FDA for a determination
(congenital or acquired) CFR 60.30), any interested person may regarding whether the applicant for
Subsequent to this approval, the petition FDA for a determination extension acted with due diligence
USPTO received a patent term regarding whether the applicant for during the regulatory review period by
restoration application for AVEED (U.S. extension acted with due diligence August 14, 2018. See ‘‘Petitions’’ in the
Patent No. 8,338,395) from Bayer during the regulatory review period. To SUPPLEMENTARY INFORMATION section for
Intellectual Property GmbH, and the meet its burden, the petition must more information.
USPTO requested FDA’s assistance in comply with all the requirements of ADDRESSES: You may submit comments
sradovich on DSK3GMQ082PROD with NOTICES

determining this patent’s eligibility for § 60.30, including but not limited to: as follows. Please note that late,
patent term restoration. In a letter dated Must be timely (see DATES), must be untimely filed comments will not be
November 2, 2015, FDA advised the filed in accordance with § 10.20, must considered. Electronic comments must
USPTO that this human drug product contain sufficient facts to merit an FDA be submitted on or before April 16,
had undergone a regulatory review investigation, and must certify that a 2018. The https://www.regulations.gov
period and that the approval of AVEED true and complete copy of the petition electronic filing system will accept
represented the first permitted has been served upon the patent comments until midnight Eastern Time

VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1

Document Created: 2018-02-15 00:21:18
Document Modified: 2018-02-15 00:21:18

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.
Dates		Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. 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 August 14, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Contact		Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation		83 FR 6858

83 FR 6858 - Determination of Regulatory Review Period for Purposes of Patent Extension; AVEED

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration