83 FR 5790 - Determination of Regulatory Review Period for Purposes of Patent Extension; ONIVYDE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range		5790-5791
FR Document		2018-02590

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

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018)

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5790-5791]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02590]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2267 and FDA-2016-E-2269]

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

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 ONIVYDE 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 drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 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 Nos.
FDA-2016-E-2267 and FDA-2016-E-2269 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ONIVYDE.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the dockets 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,

[[Page 5791]]

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 ONIVYDE
(irinotecan sucrose octasulfate). ONIVYDE in combination with
fluorouracil and leucovorin, is indicated for the treatment of patients
with metastatic adenocarcinoma of the pancreas after disease
progression following gemcitabine-based therapy. Subsequent to this
approval, the USPTO received patent term restoration applications for
ONIVYDE (U.S. Patent Nos. 8,147,867 and 8,329,213) from Merrimack
Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated August 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ONIVYDE 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
ONIVYDE is 2,536 days. Of this time, 2,354 days occurred during the
testing phase of the regulatory review period, while 182 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:
November 13, 2008. FDA has verified the applicant's claim that November
13, 2008, is the date the investigational new drug application became
effective.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 24,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for ONIVYDE (NDA 207793) was initially submitted on
April 24, 2015.
3. The date the application was approved: October 22, 2015. FDA has
verified the applicant's claim that NDA 207793 was approved on October
22, 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 its applications for patent extension,
this applicant seeks 613 days or 1,215 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 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02590 Filed 2-8-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5791

10903 New Hampshire Ave., Bldg. 51, of the product. Thereafter, the USPTO Petitions should be in the format
Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the specified in 21 CFR 10.30.
301–796–3600. product’s regulatory review period. Submit petitions electronically to
SUPPLEMENTARY INFORMATION: https://www.regulations.gov at Docket
II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written
I. Background Period petitions (two copies are required) to the
The Drug Price Competition and FDA has determined that the Dockets Management Staff (HFA–305),
Patent Term Restoration Act of 1984 applicable regulatory review period for Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic ONIVYDE is 2,536 days. Of this time, Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term 2,354 days occurred during the testing 20852.
Restoration Act (Pub. L. 100–670) phase of the regulatory review period, Dated: February 5, 2018.
generally provide that a patent may be while 182 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. 2018–02590 Filed 2–8–18; 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: November 13, DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s 2008. FDA has verified the applicant’s HUMAN SERVICES
regulatory review period forms the basis claim that November 13, 2008, is the
for determining the amount of extension date the investigational new drug Health Resources and Services
an applicant may receive. application became effective. Administration
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 Agency Information Collection
an approval phase. For human drug Activities: Proposed Collection: Public
human drug product under section
products, the testing phase begins when Comment Request, Information
505(b) of the FD&C Act: April 24, 2015.
the exemption to permit the clinical Collection Request Title: The Maternal,
FDA has verified the applicant’s claim
investigations of the drug becomes Infant, and Early Childhood Home
that the new drug application (NDA) for
effective and runs until the approval Visiting Program Performance
ONIVYDE (NDA 207793) was initially
phase begins. The approval phase starts Measurement Information System,
submitted on April 24, 2015.
with the initial submission of an OMB Number: 0906–0017—Revision
application to market the human drug 3. The date the application was
product and continues until FDA grants approved: October 22, 2015. FDA has AGENCY: Health Resources and Services
permission to market the drug product. verified the applicant’s claim that NDA Administration (HRSA), Department of
Although only a portion of a regulatory 207793 was approved on October 22, Health and Human Services.
review period may count toward the 2015. ACTION: Notice.
actual amount of extension that the This determination of the regulatory
review period establishes the maximum SUMMARY: In compliance with the
Director of USPTO may award (for
potential length of a patent extension. requirement for opportunity for public
example, half the testing phase must be
However, the USPTO applies several comment on proposed data collection
subtracted as well as any time that may
statutory limitations in its calculations projects of the Paperwork Reduction Act
have occurred before the patent was
of the actual period for patent extension. of 1995, HRSA announces plans to
issued), FDA’s determination of the
In its applications for patent extension, submit an Information Collection
length of a regulatory review period for
this applicant seeks 613 days or 1,215 Request (ICR), described below, to the
a human drug product will include all
days of patent term extension. Office of Management and Budget
of the testing phase and approval phase
(OMB). Prior to submitting the ICR to
as specified in 35 U.S.C. 156(g)(1)(B). III. Petitions OMB, HRSA seeks comments from the
FDA has approved for marketing the
Anyone with knowledge that any of public regarding the burden estimate,
human drug product ONIVYDE
the dates as published are incorrect may below, or any other aspect of the ICR.
(irinotecan sucrose octasulfate).
ONIVYDE in combination with submit either electronic or written DATES: Comments on this ICR should be
fluorouracil and leucovorin, is indicated comments and, under 21 CFR 60.24, ask received no later than April 10, 2018.
for the treatment of patients with for a redetermination (see DATES). ADDRESSES: Submit your comments to
metastatic adenocarcinoma of the Furthermore, as specified in § 60.30 (21 paperwork@hrsa.gov or mail the HRSA
pancreas after disease progression CFR 60.30), any interested person may Information Collection Clearance
following gemcitabine-based therapy. petition FDA for a determination Officer, 14N39, 5600 Fishers Lane,
Subsequent to this approval, the USPTO regarding whether the applicant for Rockville, MD 20857.
received patent term restoration extension acted with due diligence FOR FURTHER INFORMATION CONTACT: To
applications for ONIVYDE (U.S. Patent during the regulatory review period. To request more information on the
Nos. 8,147,867 and 8,329,213) from meet its burden, the petition must proposed project or to obtain a copy of
Merrimack Pharmaceuticals, Inc., and comply with all the requirements of the data collection plans and draft
the USPTO requested FDA’s assistance § 60.30, including but not limited to: instruments, email paperwork@hrsa.gov
in determining the patents’ eligibility must be timely (see DATES), must be or call Lisa Wright-Solomon, the HRSA
sradovich on DSK3GMQ082PROD with NOTICES

for patent term restoration. In a letter filed in accordance with § 10.20, must Information Collection Clearance Officer
dated August 12, 2016, FDA advised the contain sufficient facts to merit an FDA at (301) 443–1984.
USPTO that this human drug product investigation, and must certify that a SUPPLEMENTARY INFORMATION: When
had undergone a regulatory review true and complete copy of the petition submitting comments or requesting
period and that the approval of has been served upon the patent information, please include the
ONIVYDE represented the first applicant. (See H. Rept. 857, part 1, 98th information request collection title for
permitted commercial marketing or use Cong., 2d sess., pp. 41–42, 1984.) reference.

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Document Created: 2018-02-09 00:12:05
Document Modified: 2018-02-09 00:12:05

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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 10, 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 8, 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 5790

83 FR 5790 - Determination of Regulatory Review Period for Purposes of Patent Extension; ONIVYDE

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration