82 FR 46496 - Determination of Regulatory Review Period for Purposes of Patent Extension; KOVALTRY

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

Page Range		46496-46497
FR Document		2017-21421

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KOVALTRY 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 biological product.

Federal Register, Volume 82 Issue 192 (Thursday, October 5, 2017)

[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46496-46497]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-21421]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2479]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for KOVALTRY 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
biological 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
December 4, 2017. 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 April 3,
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 December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 4, 2017. 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-2016-E-2479 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; KOVALTRY.'' 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

[[Page 46497]]

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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product KOVALTRY
(antihemophilic factor (recombinant)). KOVALTRY is indicated for use in
adults and children with hemophilia A for: (1) On-demand treatment and
control of bleeding episodes; (2) perioperative management of bleeding;
and (3) routine prophylaxis to reduce the frequency of bleeding
episodes. Subsequent to this approval, the USPTO received a patent term
restoration application for KOVALTRY (U.S. Patent No. 5,804,420) from
Bayer HealthCare LLC, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 14, 2016, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of KOVALTRY 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
KOVALTRY is 2,478 days. Of this time, 2,021 days occurred during the
testing phase of the regulatory review period, while 457 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 (21 U.S.C. 355(i)) became effective: June 5,
2009. FDA has verified the Bayer HealthCare LLC's claim that the date
the investigational new drug application became effective was on June
5, 2009.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 16, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
KOVALTRY (BLA 125574/0) was initially submitted on December 16, 2014.
3. The date the application was approved: March 16, 2016. FDA has
verified the applicant's claim that BLA 125574/0 was approved on March
16, 2016.
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 1,466 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: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21421 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46497

extended for a period of up to 5 years phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD
so long as the patented item (human while 457 days occurred during the 20852.
drug product, animal drug product, approval phase. These periods of time Dated: September 29, 2017.
medical device, food additive, or color were derived from the following dates: Anna K. Abram,
additive) was subject to regulatory 1. The date an exemption under Deputy Commissioner for Policy, Planning,
review by FDA before the item was section 505(i) of the Federal Food, Drug, Legislation, and Analysis.
marketed. Under these acts, a product’s and Cosmetic Act (21 U.S.C. 355(i)) [FR Doc. 2017–21421 Filed 10–4–17; 8:45 am]
regulatory review period forms the basis became effective: June 5, 2009. FDA has
BILLING CODE 4164–01–P
for determining the amount of extension verified the Bayer HealthCare LLC’s
an applicant may receive. claim that the date the investigational
A regulatory review period consists of new drug application became effective DEPARTMENT OF HEALTH AND
two periods of time: A testing phase and was on June 5, 2009. HUMAN SERVICES
an approval phase. For human 2. The date the application was
biological products, the testing phase initially submitted with respect to the Food and Drug Administration
begins when the exemption to permit human biological product under section
the clinical investigations of the [Docket No. FDA–2017–N–0001]
351 of the Public Health Service Act (42
biological product becomes effective U.S.C. 262): December 16, 2014. FDA
and runs until the approval phase Science Advisory Board to the
has verified the applicant’s claim that National Center for Toxicological
begins. The approval phase starts with the biologics license application (BLA)
the initial submission of an application Research Advisory Committee; Notice
for KOVALTRY (BLA 125574/0) was of Meeting
to market the human biological product initially submitted on December 16,
and continues until FDA grants 2014. AGENCY: Food and Drug Administration,
permission to market the biological 3. The date the application was HHS.
product. Although only a portion of a approved: March 16, 2016. FDA has ACTION: Notice.
regulatory review period may count
verified the applicant’s claim that BLA
toward the actual amount of extension SUMMARY: The Food and Drug
125574/0 was approved on March 16,
that the Director of USPTO may award Administration (FDA) announces a
2016.
(for example, half the testing phase must forthcoming public advisory committee
This determination of the regulatory meeting of the Science Advisory Board
be subtracted as well as any time that
may have occurred before the patent review period establishes the maximum (SAB) to the National Center for
was issued), FDA’s determination of the potential length of a patent extension. Toxicological Research (NCTR). The
length of a regulatory review period for However, the USPTO applies several general function of the committee is to
a human biological product will include statutory limitations in its calculations provide advice and recommendations to
all of the testing phase and approval of the actual period for patent extension. the Agency on FDA’s regulatory issues.
phase as specified in 35 U.S.C. In its application for patent extension, At least one portion of the meeting will
156(g)(1)(B). this applicant seeks 1,466 days of patent be closed to the public.
FDA has approved for marketing the term extension.
DATES: The meeting will be held on
human biologic product KOVALTRY III. Petitions November 6, 2017, from 8 a.m. to 5
(antihemophilic factor (recombinant)). p.m., and on November 7, 2017, from 8
KOVALTRY is indicated for use in Anyone with knowledge that any of
the dates as published are incorrect may a.m. to 11:20 a.m.
adults and children with hemophilia A ADDRESSES: Heifer Village, One World
for: (1) On-demand treatment and submit either electronic or written
comments and, under 21 CFR 60.24, ask Avenue, Little Rock, AR 72202.
control of bleeding episodes; (2) Answers to commonly asked questions
perioperative management of bleeding; for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21 including information regarding special
and (3) routine prophylaxis to reduce
CFR 60.30), any interested person may accommodations due to a disability,
the frequency of bleeding episodes.
petition FDA for a determination visitor parking, and transportation may
Subsequent to this approval, the USPTO
regarding whether the applicant for be accessed at: https://www.fda.gov/
received a patent term restoration
extension acted with due diligence AdvisoryCommittees/AboutAdvisory
application for KOVALTRY (U.S. Patent
during the regulatory review period. To Committees/ucm408555.htm and
No. 5,804,420) from Bayer HealthCare
meet its burden, the petition must https://www.heifer.org/what-you-can-
LLC, and the USPTO requested FDA’s
comply with all the requirements of do/experience-heifer/heifer-village/
assistance in determining this patent’s
§ 60.30, including but not limited to: index.html.
eligibility for patent term restoration. In
a letter dated October 14, 2016, FDA Must be timely (see DATES), must be FOR FURTHER INFORMATION CONTACT:
advised the USPTO that this human filed in accordance with § 10.20, must Donna Mendrick, National Center for
biological product had undergone a contain sufficient facts to merit an FDA Toxicological Research, Food and Drug
regulatory review period and that the investigation, and must certify that a Administration, 10903 New Hampshire
approval of KOVALTRY represented the true and complete copy of the petition Ave., Bldg. 32, Rm. 2208, Silver Spring,
first permitted commercial marketing or has been served upon the patent MD 20993–0002, 301–796–8892, or FDA
use of the product. Thereafter, the applicant. (See H. Rept. 857, part 1, 98th Advisory Committee Information Line,
USPTO requested that FDA determine Cong., 2d sess., pp. 41–42, 1984.) 1–800–741–8138 (301–443–0572 in the
the product’s regulatory review period. Petitions should be in the format Washington, DC area). A notice in the
ethrower on DSK3G9T082PROD with NOTICES

specified in 21 CFR 10.30. Federal Register about last minute
II. Determination of Regulatory Review Submit petitions electronically to modifications that impact a previously
Period https://www.regulations.gov at Docket announced advisory committee meeting
FDA has determined that the No. FDA–2013–S–0610. Submit written cannot always be published quickly
applicable regulatory review period for petitions (two copies are required) to the enough to provide timely notice.
KOVALTRY is 2,478 days. Of this time, Dockets Management Staff (HFA–305), Therefore, you should always check the
2,021 days occurred during the testing Food and Drug Administration, 5630 Agency’s Web site at https://

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Document Created: 2017-10-05 00:53:24
Document Modified: 2017-10-05 00:53:24

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 December 4, 2017. 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 April 3, 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		82 FR 46496

82 FR 46496 - Determination of Regulatory Review Period for Purposes of Patent Extension; KOVALTRY

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration