83 FR 4213 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPATIER

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range		4213-4214
FR Document		2018-01642

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEPATIER 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 20 (Tuesday, January 30, 2018)

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4213-4214]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01642]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2521]

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

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 ZEPATIER 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.

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-2521 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZEPATIER.'' 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:

[[Page 4214]]

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 ZEPATIER
(grazoprevir; elbasvir). ZEPATIER is indicated with or without
ribavirin for treatment of chronic hepatitis C virus genotypes 1 or 4
infection in adults. Subsequent to this approval, the USPTO received a
patent term restoration application for ZEPATIER (U.S. Patent No.
7,973,040) from Merck Sharp & Dohme Corp. and MSD Italia s.r.l., and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated November 10,
2016, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of ZEPATIER
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
ZEPATIER is 1,865 days. Of this time, 1,619 days occurred during the
testing phase of the regulatory review period, while 246 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:
December 22, 2010. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
December 22, 2010.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 28,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for ZEPATIER (NDA 208-261) was initially submitted on
May 28, 2015.
3. The date the application was approved: January 28, 2016. FDA has
verified the applicant's claim that NDA 208-261 was approved on January
28, 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 188 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: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01642 Filed 1-29-18; 8:45 am]
BILLING CODE 4164-01-P

4214 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices

I. Background II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written
Period petitions (two copies are required) to the
The Drug Price Competition and Dockets Management Staff (HFA–305),
Patent Term Restoration Act of 1984 FDA has determined that the
applicable regulatory review period for Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term ZEPATIER is 1,865 days. Of this time,
1,619 days occurred during the testing 20852.
Restoration Act (Pub. L. 100–670) Dated: January 24, 2018.
phase of the regulatory review period,
generally provide that a patent may be
while 246 days occurred during the Leslie Kux,
extended for a period of up to 5 years approval phase. These periods of time Associate Commissioner for Policy.
so long as the patented item (human were derived from the following dates: [FR Doc. 2018–01642 Filed 1–29–18; 8:45 am]
drug product, animal drug product, 1. The date an exemption under BILLING CODE 4164–01–P
medical device, food additive, or color section 505(i) of the Federal Food, Drug,
additive) was subject to regulatory and Cosmetic Act (FD&C Act) (21 U.S.C.
review by FDA before the item was 355(i)) became effective: December 22, DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s 2010. FDA has verified the applicant’s HUMAN SERVICES
regulatory review period forms the basis claim that the date the investigational
for determining the amount of extension new drug application became effective Food and Drug Administration
an applicant may receive. was on December 22, 2010. [Docket No. FDA–2016–E–2530]
A regulatory review period consists of 2. The date the application was
two periods of time: A testing phase and initially submitted with respect to the Determination of Regulatory Review
an approval phase. For human drug human drug product under section Period for Purposes of Patent
products, the testing phase begins when 505(b) of the FD&C Act: May 28, 2015. Extension; GALLIPRANT
the exemption to permit the clinical FDA has verified the applicant’s claim
that the new drug application (NDA) for AGENCY: Food and Drug Administration,
investigations of the drug becomes HHS.
ZEPATIER (NDA 208–261) was initially
effective and runs until the approval ACTION: Notice.
submitted on May 28, 2015.
phase begins. The approval phase starts 3. The date the application was
with the initial submission of an approved: January 28, 2016. FDA has SUMMARY: The Food and Drug
application to market the human drug verified the applicant’s claim that NDA Administration (FDA or the Agency) has
product and continues until FDA grants 208–261 was approved on January 28, determined the regulatory review period
permission to market the drug product. 2016. for GALLIPRANT and is publishing this
Although only a portion of a regulatory This determination of the regulatory notice of that determination as required
review period may count toward the review period establishes the maximum by law. FDA has made the
actual amount of extension that the potential length of a patent extension. determination because of the
Director of USPTO may award (for However, the USPTO applies several submission of an application to the
example, half the testing phase must be statutory limitations in its calculations Director of U.S. Patent and Trademark
subtracted as well as any time that may of the actual period for patent extension. Office (USPTO), Department of
In its application for patent extension, Commerce, for the extension of a patent
have occurred before the patent was
this applicant seeks 188 days of patent which claims that animal drug product.
issued), FDA’s determination of the
term extension. DATES: Anyone with knowledge that any
length of a regulatory review period for
a human drug product will include all of the dates as published (in the
III. Petitions SUPPLEMENTARY INFORMATION section) are
of the testing phase and approval phase
Anyone with knowledge that any of incorrect may submit either electronic
as specified in 35 U.S.C. 156(g)(1)(B).
the dates as published are incorrect may or written comments and, ask for a
FDA has approved for marketing the submit either electronic or written redetermination by April 2, 2018.
human drug product ZEPATIER comments and, under 21 CFR 60.24, ask Furthermore, any interested person may
(grazoprevir; elbasvir). ZEPATIER is for a redetermination (see DATES). petition FDA for a determination
indicated with or without ribavirin for Furthermore, as specified in § 60.30 (21 regarding whether the applicant for
treatment of chronic hepatitis C virus CFR 60.30), any interested person may extension acted with due diligence
genotypes 1 or 4 infection in adults. petition FDA for a determination during the regulatory review period by
Subsequent to this approval, the USPTO regarding whether the applicant for July 30, 2018. See ‘‘Petitions’’ in the
received a patent term restoration extension acted with due diligence SUPPLEMENTARY INFORMATION section for
application for ZEPATIER (U.S. Patent during the regulatory review period. To more information.
No. 7,973,040) from Merck Sharp & meet its burden, the petition must ADDRESSES: You may submit comments
Dohme Corp. and MSD Italia s.r.l., and comply with all the requirements of as follows. Please note that late,
the USPTO requested FDA’s assistance § 60.30, including but not limited to: untimely filed comments will not be
in determining this patent’s eligibility Must be timely (see DATES), must be considered. Electronic comments must
for patent term restoration. In a letter filed in accordance with § 10.20, must be submitted on or before April 2, 2018.
dated November 10, 2016, FDA advised contain sufficient facts to merit an FDA The https://www.regulations.gov
the USPTO that this human drug investigation, and must certify that a electronic filing system will accept
product had undergone a regulatory true and complete copy of the petition comments until midnight Eastern Time
daltland on DSKBBV9HB2PROD with NOTICES

review period and that the approval of has been served upon the patent at the end of April 2, 2018. Comments
ZEPATIER represented the first applicant. (See H. Rept. 857, part 1, 98th received by mail/hand delivery/courier
Cong., 2d sess., pp. 41–42, 1984.) (for written/paper submissions) will be
permitted commercial marketing or use
Petitions should be in the format considered timely if they are
of the product. Thereafter, the USPTO
specified in 21 CFR 10.30. postmarked or the delivery service
requested that FDA determine the
Submit petitions electronically to acceptance receipt is on or before that
product’s regulatory review period. https://www.regulations.gov at Docket date.

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Document Created: 2018-10-26 10:10:47
Document Modified: 2018-10-26 10:10:47

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 4213

83 FR 4213 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPATIER

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration