82 FR 61010 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 246 (December 26, 2017)

Page Range		61010-61011
FR Document		2017-27745

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYKADIA 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 82 Issue 246 (Tuesday, December 26, 2017)

[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61010-61011]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-27745]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2655 and FDA-2015-E-2656]

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

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 ZYKADIA 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 26, 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 February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 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. 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 June 25, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.

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-2015-E-2655 and FDA-2015-E-2656 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ZYKADIA.'' 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 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.

[[Page 61011]]

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 ZYKADIA
(ceritinib). ZYKADIA is indicated for the treatment of patients with
anaplastic lymphoma kinase-positive metastatic non-small cell lung
cancer who have progressed on or are intolerant to crizotinib. This
indication is approved under accelerated approval based on tumor
response rate and duration of response. An improvement in survival or
disease-related symptoms has not been established. Continued approval
for this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials. Subsequent to this
approval, the USPTO received patent term restoration applications for
ZYKADIA (U.S. Patent Nos. 7,964,592 from Novartis AG and and 8,377,921
from IRM LLC), and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
October 15, 2015, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
ZYKADIA 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
ZYKADIA is 1,271 days. Of this time, 1,144 days occurred during the
testing phase of the regulatory review period, while 127 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 7, 2010. FDA has verified the applicants' claims that November
7, 2010, 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: December
24, 2013. FDA has verified the applicants' claims that the new drug
application (NDA) for ZYKADIA (NDA 205755) was initially submitted on
December 24, 2013.
3. The date the application was approved: April 29, 2014. FDA has
verified the applicants' claims that NDA 205755 was approved on April
29, 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 their applications for patent
extension, these applicants seek 472 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 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: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27745 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices 61011

A regulatory review period consists of 1. The date an exemption under Dated: December 20, 2017.
two periods of time: A testing phase and section 505(i) of the Federal Food, Drug, Leslie Kux,
an approval phase. For human drug and Cosmetic Act (FD&C Act) (21 U.S.C. Associate Commissioner for Policy.
products, the testing phase begins when 355(i)) became effective: November 7, [FR Doc. 2017–27745 Filed 12–22–17; 8:45 am]
the exemption to permit the clinical 2010. FDA has verified the applicants’ BILLING CODE 4164–01–P
investigations of the drug becomes claims that November 7, 2010, is the
effective and runs until the approval date the investigational new drug
phase begins. The approval phase starts application became effective. DEPARTMENT OF HEALTH AND
with the initial submission of an HUMAN SERVICES
application to market the human drug 2. The date the application was
product and continues until FDA grants initially submitted with respect to the Food and Drug Administration
permission to market the drug product. human drug product under section
505(b) of the FD&C Act: December 24, [Docket No. FDA–2015–D–1245]
Although only a portion of a regulatory
review period may count toward the 2013. FDA has verified the applicants’ Waiver of In Vivo Bioavailability and
actual amount of extension that the claims that the new drug application Bioequivalence Studies for Immediate-
Director of USPTO may award (for (NDA) for ZYKADIA (NDA 205755) was Release Solid Oral Dosage Forms
example, half the testing phase must be initially submitted on December 24, Based on a Biopharmaceutics
subtracted as well as any time that may 2013. Classification System; Guidance for
have occurred before the patent was 3. The date the application was Industry; Availability
issued), FDA’s determination of the approved: April 29, 2014. FDA has
length of a regulatory review period for AGENCY: Food and Drug Administration,
verified the applicants’ claims that NDA
a human drug product will include all HHS.
205755 was approved on April 29, 2014.
of the testing phase and approval phase ACTION: Notice of availability.
as specified in 35 U.S.C. 156(g)(1)(B). This determination of the regulatory
FDA has approved for marketing the review period establishes the maximum SUMMARY: The Food and Drug
human drug product ZYKADIA potential length of a patent extension. Administration (FDA or Agency) is
(ceritinib). ZYKADIA is indicated for However, the USPTO applies several announcing the availability of a
the treatment of patients with anaplastic statutory limitations in its calculations guidance for industry entitled ‘‘Waiver
lymphoma kinase-positive metastatic of the actual period for patent extension. of In Vivo Bioavailability and
non-small cell lung cancer who have In their applications for patent Bioequivalence Studies for Immediate-
progressed on or are intolerant to extension, these applicants seek 472 Release Solid Oral Dosage Forms Based
crizotinib. This indication is approved days of patent term extension. on a Biopharmaceutics Classification
under accelerated approval based on System.’’ This guidance finalizes
III. Petitions recommendations for sponsors of
tumor response rate and duration of
response. An improvement in survival investigational new drug applications
Anyone with knowledge that any of (INDs), and applicants who submit new
or disease-related symptoms has not the dates as published are incorrect may
been established. Continued approval drug applications (NDAs), abbreviated
submit either electronic or written new drug applications (ANDAs), and
for this indication may be contingent comments and, under 21 CFR 60.24 ask
upon verification and description of supplements to these applications for
for a redetermination (see DATES). immediate-release (IR) solid oral dosage
clinical benefit in confirmatory trials. Furthermore, as specified in § 60.30 (21
Subsequent to this approval, the USPTO forms, and who wish to request a waiver
CFR 60.30), any interested person may of an in vivo bioavailability (BA) and/
received patent term restoration petition FDA for a determination
applications for ZYKADIA (U.S. Patent or bioequivalence (BE) study
regarding whether the applicant for requirement.
Nos. 7,964,592 from Novartis AG and
extension acted with due diligence DATES: The announcement of the
and 8,377,921 from IRM LLC), and the
USPTO requested FDA’s assistance in during the regulatory review period. To guidance is published in the Federal
determining the patents’ eligibility for meet its burden, the petition comply Register on December 26, 2017.
patent term restoration. In a letter dated with all the requirements of § 60.30,
ADDRESSES: You may submit either
October 15, 2015, FDA advised the including but not limited to: must be
electronic or written comments on
USPTO that this human drug product timely (see DATES), must be filed in Agency guidances at any time as
had undergone a regulatory review accordance with § 10.20, must contain follows:
period and that the approval of sufficient facts to merit an FDA
ZYKADIA represented the first investigation, and must certify that a Electronic Submissions
permitted commercial marketing or use true and complete copy of the petition Submit electronic comments in the
of the product. Thereafter, the USPTO has been served upon the patent following way:
requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th • Federal eRulemaking Portal:
product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) https://www.regulations.gov. Follow the
Petitions should be in the format instructions for submitting comments.
II. Determination of Regulatory Review
Period specified in 21 CFR 10.30. Comments submitted electronically,
Submit petitions electronically to including attachments, to https://
FDA has determined that the https://www.regulations.gov at Docket www.regulations.gov will be posted to
ethrower on DSK3G9T082PROD with NOTICES

applicable regulatory review period for No. FDA–2013–S–0610. Submit written the docket unchanged. Because your
ZYKADIA is 1,271 days. Of this time, comment will be made public, you are
petitions (two copies are required) to the
1,144 days occurred during the testing solely responsible for ensuring that your
Dockets Management Staff (HFA–305),
phase of the regulatory review period, comment does not include any
while 127 days occurred during the Food and Drug Administration, 5630
confidential information that you or a
approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD third party may not wish to be posted,
were derived from the following dates: 20852. such as medical information, your or

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Document Created: 2017-12-23 03:08:04
Document Modified: 2017-12-23 03:08:04

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 February 26, 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 61010

82 FR 61010 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 246 (December 26, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration