82 FR 36794 - Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

Page Range		36794-36795
FR Document		2017-16515

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VONVENDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 150 (Monday, August 7, 2017)

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36794-36795]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-16515]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2171, FDA-2016-E-2169, and FDA-2016-E-2170]

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

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 VONVENDI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications 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 October
6, 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 February 5, 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 October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 6, 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 Nos.
FDA-2016-E-2171, FDA-2016-E-2169, and FDA-2016-E-2170 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; VONVENDI.'' 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 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the

[[Page 36795]]

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 VONVENDI
(von Willebrand Factor (Recombinant)). VONVENDI is indicated for on-
demand treatment and control of bleeding episodes in adults diagnosed
with von Willebrand disease. Subsequent to this approval, the USPTO
received patent term restoration applications for VONVENDI (U.S. Patent
Nos. 6,465,624; 6,531,577; and 6,579,723) from Baxalta GmbH and Baxalta
Inc., and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
September 1, 2016, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of VONVENDI 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
VONVENDI is 2,690 days. Of this time, 2,335 days occurred during the
testing phase of the regulatory review period, while 355 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: July 29,
2008. The applicants claim July 30, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 29, 2008,
which was 30 days after FDA receipt of the IND.
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 19, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
VONVENDI (BLA 125577) was initially submitted on December 19, 2014.
3. The date the application was approved: December 8, 2015. FDA has
verified the applicant's claim that BLA 125577 was approved on December
8, 2015.
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 the applications for patent extension,
these applicants seek 1,521 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 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 be timely (see DATES) and 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.
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: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16515 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36795

biological product becomes effective 351 of the Public Health Service Act (42 DEPARTMENT OF HEALTH AND
and runs until the approval phase U.S.C. 262): December 19, 2014. FDA HUMAN SERVICES
begins. The approval phase starts with has verified the applicant’s claim that
the initial submission of an application the biologics license application (BLA) Food and Drug Administration
to market the human biological product for VONVENDI (BLA 125577) was [Docket No. FDA–2014–N–0222]
and continues until FDA grants initially submitted on December 19,
permission to market the biological 2014. Agency Information Collection
product. Although only a portion of a Activities; Submission for Office of
regulatory review period may count 3. The date the application was
Management and Budget Review;
toward the actual amount of extension approved: December 8, 2015. FDA has
Comment Request; Guidance for
that the Director of USPTO may award verified the applicant’s claim that BLA
Industry—User Fee Waivers,
(for example, half the testing phase must 125577 was approved on December 8,
Reductions, and Refunds for Drug and
be subtracted as well as any time that 2015. Biological Products
may have occurred before the patent This determination of the regulatory
was issued), FDA’s determination of the review period establishes the maximum AGENCY: Food and Drug Administration,
length of a regulatory review period for HHS.
potential length of a patent extension.
a human biological product will include However, the USPTO applies several ACTION: Notice.
all of the testing phase and approval statutory limitations in its calculations
phase as specified in 35 U.S.C. SUMMARY: The Food and Drug
of the actual period for patent extension. Administration (FDA, Agency or we) is
156(g)(1)(B).
In the applications for patent extension, announcing that a proposed collection
FDA has approved for marketing the
human biologic product VONVENDI these applicants seek 1,521 days of of information has been submitted to the
(von Willebrand Factor (Recombinant)). patent term extension. Office of Management and Budget
VONVENDI is indicated for on-demand (OMB) for review and clearance under
III. Petitions
treatment and control of bleeding the Paperwork Reduction Act of 1995.
episodes in adults diagnosed with von Anyone with knowledge that any of DATES: Fax written comments on the
Willebrand disease. Subsequent to this the dates as published are incorrect may collection of information by September
approval, the USPTO received patent submit either electronic or written 6, 2017.
term restoration applications for comments and, under 21 CFR 60.24, ask ADDRESSES: To ensure that comments on
VONVENDI (U.S. Patent Nos. 6,465,624; for a redetermination (see DATES). the information collection are received,
6,531,577; and 6,579,723) from Baxalta Furthermore, as specified in 21 CFR OMB recommends that written
GmbH and Baxalta Inc., and the USPTO 60.30, any interested person may comments be faxed to the Office of
requested FDA’s assistance in petition FDA for a determination Information and Regulatory Affairs,
determining the patents’ eligibility for regarding whether the applicant for OMB, Attn: FDA Desk Officer, FAX:
patent term restoration. In a letter dated extension acted with due diligence 202–395–7285, or emailed to oira_
September 1, 2016, FDA advised the submission@omb.eop.gov. All
during the regulatory review period. To
USPTO that this human biological comments should be identified with the
meet its burden, the petition must be
product had undergone a regulatory OMB control number 0910–0693. Also
review period and that the approval of timely (see DATES) and contain sufficient
include the FDA docket number found
VONVENDI represented the first facts to merit an FDA investigation. (See
in brackets in the heading of this
permitted commercial marketing or use H. Rept. 857, part 1, 98th Cong., 2d
document.
of the product. Thereafter, the USPTO sess., pp. 41–42, 1984.) Petitions should
be in the format specified in 21 CFR FOR FURTHER INFORMATION CONTACT:
requested that FDA determine the
10.30. Domini Bean, Office of Operations,
product’s regulatory review period.
Food and Drug Administration, Three
II. Determination of Regulatory Review Submit petitions electronically to White Flint North, 10A63, 11601
Period https://www.regulations.gov at Docket Landsdown St., North Bethesda, MD
No. FDA–2013–S–0610. Submit written 20852, 301–796–5733, PRAStaff@
FDA has determined that the petitions (two copies are required) to the
applicable regulatory review period for fda.hhs.gov.
Dockets Management Staff (HFA–305),
VONVENDI is 2,690 days. Of this time, SUPPLEMENTARY INFORMATION: In
Food and Drug Administration, 5630
2,335 days occurred during the testing compliance with 44 U.S.C. 3507, FDA
Fishers Lane, Rm. 1061, Rockville, MD
phase of the regulatory review period, has submitted the following proposed
while 355 days occurred during the 20852. collection of information to OMB for
approval phase. These periods of time Dated: August 1, 2017. review and clearance.
were derived from the following dates: Anna K. Abram,
1. The date an exemption under Guidance for Industry—User Fee
Deputy Commissioner for Policy, Planning, Waivers, Reductions, and Refunds for
section 505(i) of the Federal Food, Drug, Legislation, and Analysis.
and Cosmetic Act (21 U.S.C. 355(i)) Drug and Biological Products OMB
[FR Doc. 2017–16515 Filed 8–4–17; 8:45 am] Control Number 0910–0693—Extension
became effective: July 29, 2008. The
BILLING CODE 4164–01–P The guidance provides
applicants claim July 30, 2008, as the
date the investigational new drug recommendations for applicants
application (IND) became effective. planning to request waivers or
mstockstill on DSK30JT082PROD with NOTICES

However, FDA records indicate that the reductions in prescription drug user fees
IND effective date was July 29, 2008, assessed under sections 735 and 736 of
which was 30 days after FDA receipt of the Federal Food, Drug, and Cosmetic
the IND. Act (21 U.S.C. 379g and 21 U.S.C. 379h)
2. The date the application was (the FD&C Act). The guidance describes
initially submitted with respect to the the types of waivers and reductions
human biological product under section permitted under the prescription drug

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Document Created: 2017-08-05 03:00:04
Document Modified: 2017-08-05 03:00:04

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 October 6, 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 February 5, 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 36794

82 FR 36794 - Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration