83 FR 4487 - Determination of Regulatory Review Period for Purposes of Patent Extension; DUAVEE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 21 (January 31, 2018)

Page Range		4487-4489
FR Document		2018-01894

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DUAVEE 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 21 (Wednesday, January 31, 2018)

[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4487-4489]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01894]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-2339; FDA-2014-E-2338]

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

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 DUAVEE 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
2, 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 July 30, 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 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 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.

[[Page 4488]]

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-2014-E-2339 and FDA-2014-E-2338 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; DUAVEE.'' 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.

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 DUAVEE
(conjugated estrogens/bazedoxifene acetate). DUAVEE is indicated for
treatment of the following conditions in women with a uterus: (1)
Treatment of moderate to severe vasomotor symptoms associated with
menopause and (2) prevention of postmenopausal osteoporosis. Subsequent
to this approval, the USPTO received patent term restoration
applications for DUAVEE (U.S. Patent Nos. 5,998,402 and 6,479,535) from
Wyeth LLC, and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
November 3, 2015, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
DUAVEE 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
DUAVEE is 5,683 days. Of this time, 5,317 days occurred during the
testing phase of the regulatory review period, while 366 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: March 15, 1998. FDA has verified the Wyeth LLC claim that
March 15, 1998, is the date the investigational new drug application
(IND) became effective.

[[Page 4489]]

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 3,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for DUAVEE (NDA 022247) was initially submitted on
October 3, 2012.
3. The date the application was approved: October 3, 2013. FDA has
verified the applicant's claim that NDA 022247 was approved on October
3, 2013.
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 5 years 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, 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: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01894 Filed 1-30-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices 4487

A regulatory review period consists of of the regulatory review period, while Fishers Lane, Rm. 1061, Rockville, MD
two periods of time: A testing phase and 411 days occurred during the approval 20852.
an approval phase. For medical devices, phase. These periods of time were Dated: January 26, 2018.
the testing phase begins with a clinical derived from the following dates: Leslie Kux,
investigation of the device and runs 1. The date an exemption under
section 520(g) of the Federal Food, Drug, Associate Commissioner for Policy.
until the approval phase begins. The
approval phase starts with the initial and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2018–01891 Filed 1–30–18; 8:45 am]
submission of an application to market U.S.C. 360j(g)) involving this device BILLING CODE 4164–01–P

the device and continues until became effective: September 17, 2010.
permission to market the device is FDA has verified the applicant’s claim
granted. Although only a portion of a that the date the investigational device DEPARTMENT OF HEALTH AND
regulatory review period may count exemption became effective was on HUMAN SERVICES
toward the actual amount of extension September 17, 2010.
2. The date an application was Food and Drug Administration
that the Director of USPTO may award
(half the testing phase must be initially submitted with respect to the
subtracted as well as any time that may device under section 515 of the FD&C [Docket Nos. FDA–2014–E–2339; FDA–
have occurred before the patent was Act (21 U.S.C. 360e): May 2, 2013. FDA 2014–E–2338]
issued), FDA’s determination of the has verified the applicant’s claim that
the premarket approval application Determination of Regulatory Review
length of a regulatory review period for Period for Purposes of Patent
a medical device will include all of the (PMA) for SAPIEN XT
TRANSCATHETER HEART VALVE Extension; DUAVEE
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B). (PMA P130009) was initially submitted AGENCY: Food and Drug Administration,
FDA has approved for marketing the on May 2, 2013. HHS.
medical device SAPIEN XT 3. The date the application was
TRANSCATHETER HEART VALVE. approved: June 16, 2014. FDA has ACTION: Notice.
SAPIEN XT TRANSCATHETER HEART verified the applicant’s claim that PMA
VALVE is indicated for relief of aortic P130009 was approved on June 16, SUMMARY: The Food and Drug
stenosis in patients with symptomatic 2014. Administration (FDA or the Agency) has
heart disease due to severe native This determination of the regulatory determined the regulatory review period
calcific aortic stenosis (aortic valve area review period establishes the maximum for DUAVEE and is publishing this
≤1.0 cm2 or aortic valve area index ≤0.6 potential length of a patent extension. notice of that determination as required
cm2/m2, a mean aortic valve gradient of However, the USPTO applies several by law. FDA has made the
≥40 mmHg, or a peak aortic-jet velocity statutory limitations in its calculations determination because of the
of ≥4.0 m/s), and with native anatomy of the actual period for patent extension. submission of an application to the
appropriate for the 23, 26, or 29 mm In its applications for patent extension, Director of the U.S. Patent and
valve system, who are judged by a heart this applicant seeks 889 days of patent Trademark Office (USPTO), Department
team, including a cardiac surgeon, to be term extension. of Commerce, for the extension of a
at high or greater risk for open surgical patent which claims that human drug
III. Petitions product.
therapy (i.e., Society of Thoracic
Surgeons operative risk score ≥8% or at Anyone with knowledge that any of
the dates as published are incorrect may DATES: Anyone with knowledge that any
a ≥15% risk of morality at 30 days). of the dates as published (in the
Subsequent to this approval, the USPTO submit either electronic or written
SUPPLEMENTARY INFORMATION section) are
received a patent term restoration comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES). incorrect may submit either electronic
application for SAPIEN XT or written comments and ask for a
TRANSCATHETER HEART VALVE Furthermore, as specified in 21 CFR
60.30, any interested person may redetermination by April 2, 2018.
(U.S. Patent Nos. 7,510,575 and Furthermore, any interested person may
7,585,321) from Edwards Lifesciences petition FDA for a determination
regarding whether the applicant for petition FDA for a determination
PVT, Inc., and the USPTO requested regarding whether the applicant for
FDA’s assistance in determining the extension acted with due diligence
during the regulatory review period. To extension acted with due diligence
patents’ eligibility for patent term during the regulatory review period by
restoration. In a letter dated October 15, meet its burden, the petition must
comply with all the requirements of 21 July 30, 2018. See ‘‘Petitions’’ in the
2015, FDA advised the USPTO that this SUPPLEMENTARY INFORMATION section for
medical device had undergone a CFR 60.30, including but not limited to:
Must be timely (see DATES), must be more information.
regulatory review period and that the
approval of SAPIEN XT filed in accordance with 21 CFR 10.20, ADDRESSES: You may submit comments
TRANSCATHETER HEART VALVE must contain sufficient facts to merit an as follows. Please note that late,
represented the first permitted FDA investigation, and must certify that untimely filed comments will not be
commercial marketing or use of the a true and complete copy of the petition considered. Electronic comments must
product. Thereafter, the USPTO has been served upon the patent be submitted on or before April 2, 2018.
requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th The https://www.regulations.gov
product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) electronic filing system will accept
comments until midnight Eastern Time
sradovich on DSK3GMQ082PROD with NOTICES

Petitions should be in the format
II. Determination of Regulatory Review specified in 21 CFR 10.30. at the end of April 2, 2018. Comments
Period Submit petitions electronically to received by mail/hand delivery/courier
FDA has determined that the https://www.regulations.gov at Docket (for written/paper submissions) will be
applicable regulatory review period for No. FDA–2013–S–0610. Submit written considered timely if they are
SAPIEN XT TRANSCATHETER HEART petitions (two copies are required) to the postmarked or the delivery service
VALVE is 1,370 days. Of this time, 959 Dockets Management Staff (HFA–305), acceptance receipt is on or before that
days occurred during the testing phase Food and Drug Administration, 5630 date.

VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1

Document Created: 2018-01-31 00:58:48
Document Modified: 2018-01-31 00:58:48

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 2, 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 July 30, 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 4487

83 FR 4487 - Determination of Regulatory Review Period for Purposes of Patent Extension; DUAVEE

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 21 (January 31, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration