83 FR 6038 - Determination of Regulatory Review Period for Purposes of Patent Extension; AKYNZEO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 29 (February 12, 2018)

Page Range		6038-6039
FR Document		2018-02756

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AKYNZEO 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 29 (Monday, February 12, 2018)

[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6038-6039]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02756]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-3877]

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

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 AKYNZEO 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 (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
13, 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 13, 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 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 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-2015-E-3877 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; AKYNZEO.'' 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: http://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

[[Page 6039]]

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 AKYNZEO
(netupitant/palonosetron hydrochloride). AKYNZEO is indicated for the
prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of cancer chemotherapy including, but not
limited to, highly emetogenic chemotherapy. Subsequent to this
approval, the USPTO received a patent term restoration application for
AKYNZEO (U.S. Patent No. 6,297,375) from Hoffmann-La Roche Inc., and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated October 30,
2015, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of AKYNZEO 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
AKYNZEO is 1,858 days. Of this time, 1,479 days occurred during the
testing phase of the regulatory review period, while 379 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:
September 10, 2009. FDA has verified the applicant's claim that
September 10, 2009, is the date the investigational new drug
application (IND) 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: September
27, 2013. The applicant claims September 25, 2013, as the date the new
drug application (NDA) for AKYNZEO (NDA 205718) was initially
submitted. However, FDA records indicate that NDA 205718 was submitted
on September 27, 2013.
3. The date the application was approved: October 10, 2014. FDA has
verified the applicant's claim that NDA 205718 was approved on October
10, 2014.
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 1,118 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 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02756 Filed 2-9-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 6039

with the initial submission of an However, FDA records indicate that DEPARTMENT OF HEALTH AND
application to market the human drug NDA 205718 was submitted on HUMAN SERVICES
product and continues until FDA grants September 27, 2013.
permission to market the drug product. Health Resources and Services
3. The date the application was
Although only a portion of a regulatory Administration
approved: October 10, 2014. FDA has
review period may count toward the
verified the applicant’s claim that NDA Low Income Levels Used for Various
actual amount of extension that the
Director of USPTO may award (for 205718 was approved on October 10, Health Professions and Nursing
example, half the testing phase must be 2014. Programs Authorized in Titles III, VII,
subtracted as well as any time that may This determination of the regulatory and VIII of the Public Health Service
have occurred before the patent was review period establishes the maximum Act
issued), FDA’s determination of the potential length of a patent extension.
length of a regulatory review period for AGENCY: Health Resources and Services
However, the USPTO applies several
a human drug product will include all Administration (HRSA), Department of
statutory limitations in its calculations Health and Human Services (HHS).
of the testing phase and approval phase of the actual period for patent extension.
as specified in 35 U.S.C. 156(g)(1)(B). In its application for patent extension, ACTION: Notice.
FDA has approved for marketing the this applicant seeks 1,118 days of patent
human drug product AKYNZEO SUMMARY: HRSA is updating income
term extension.
(netupitant/palonosetron levels used to identify a ‘‘low income
hydrochloride). AKYNZEO is indicated III. Petitions family’’ for the purpose of determining
for the prevention of acute and delayed eligibility for programs that provide
nausea and vomiting associated with Anyone with knowledge that any of health professions and nursing training
initial and repeat courses of cancer the dates as published are incorrect may to individuals from disadvantaged
chemotherapy including, but not submit either electronic or written backgrounds. These various programs
limited to, highly emetogenic comments and, under 21 CFR 60.24, ask are authorized in Titles III, VII, and VIII
chemotherapy. Subsequent to this for a redetermination (see DATES). of the Public Health Service Act.
approval, the USPTO received a patent Furthermore, as specified in § 60.30 (21 SUPPLEMENTARY INFORMATION: HHS
term restoration application for CFR 60.30), any interested person may periodically publishes in the Federal
AKYNZEO (U.S. Patent No. 6,297,375) petition FDA for a determination Register low-income levels to be used
from Hoffmann-La Roche Inc., and the regarding whether the applicant for by institutions receiving grants and
USPTO requested FDA’s assistance in extension acted with due diligence cooperative agreements to determine
determining this patent’s eligibility for during the regulatory review period. To eligibility for programs providing
patent term restoration. In a letter dated meet its burden, the petition must training for (1) disadvantaged
October 30, 2015, FDA advised the comply with all the requirements of individuals, (2) individuals from
USPTO that this human drug product § 60.30, including but not limited to: disadvantaged backgrounds, or (3)
had undergone a regulatory review
Must be timely (see DATES), must be individuals from low-income families.
period and that the approval of
filed in accordance with § 10.20, must Many health professions and nursing
AKYNZEO represented the first
contain sufficient facts to merit an FDA grant and cooperative agreement
permitted commercial marketing or use
investigation, and must certify that a awardees use the low-income levels to
of the product. Thereafter, the USPTO
true and complete copy of the petition determine whether potential program
requested that FDA determine the
has been served upon the patent participants are from an economically
product’s regulatory review period.
applicant. (See H. Rept. 857, part 1, 98th disadvantaged background and would
II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.) be eligible to participate in the program,
Period Petitions should be in the format as well as to determine the amount of
FDA has determined that the specified in 21 CFR 10.30. funding the individual receives. Awards
applicable regulatory review period for are generally made to accredited schools
Submit petitions electronically to of medicine, osteopathic medicine,
AKYNZEO is 1,858 days. Of this time, https://www.regulations.gov at Docket
1,479 days occurred during the testing public health, dentistry, veterinary
No. FDA–2013–S–0610. Submit written medicine, optometry, pharmacy, allied
phase of the regulatory review period,
petitions (two copies are required) to the health, podiatric medicine, nursing, and
while 379 days occurred during the
Dockets Management Staff (HFA–305), chiropractic; public or private nonprofit
approval phase. These periods of time
were derived from the following dates: Food and Drug Administration, 5630 schools which offer graduate programs
1. The date an exemption under Fishers Lane, Rm. 1061, Rockville, MD in behavioral health and mental health
section 505(i) of the Federal Food, Drug, 20852. practice; and other public or private
and Cosmetic Act (FD&C Act) (21 U.S.C. Dated: February 7, 2018. nonprofit health or education entities to
355(i)) became effective: September 10, assist the disadvantaged to enter and
Leslie Kux,
2009. FDA has verified the applicant’s graduate from health professions and
Associate Commissioner for Policy. nursing schools. Some programs
claim that September 10, 2009, is the
[FR Doc. 2018–02756 Filed 2–9–18; 8:45 am] provide for the repayment of health
date the investigational new drug
application (IND) became effective. BILLING CODE 4164–01–P professions or nursing education loans
2. The date the application was for disadvantaged students.
daltland on DSKBBV9HB2PROD with NOTICES

initially submitted with respect to the A ‘‘low-income family/household’’ for
human drug product under section programs included in Titles III, VII, and
505(b) of the FD&C Act: September 27, VIII of the Public Health Service Act is
2013. The applicant claims September defined as having an annual income that
25, 2013, as the date the new drug does not exceed 200 percent of the
application (NDA) for AKYNZEO (NDA Department’s poverty guidelines. A
205718) was initially submitted. family is a group of two or more

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Document Created: 2018-11-01 08:43:19
Document Modified: 2018-11-01 08:43:19

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 13, 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 13, 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 6038

83 FR 6038 - Determination of Regulatory Review Period for Purposes of Patent Extension; AKYNZEO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 29 (February 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration