83 FR 53067 - Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 203 (October 19, 2018)

Page Range		53067-53068
FR Document		2018-22806

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMFINZI 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 83 Issue 203 (Friday, October 19, 2018)

[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Notices]
[Pages 53067-53068]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-22806]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6544 and FDA-2017-E-6542]

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

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 IMFINZI 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 (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 18, 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 April 17,
2019. 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 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 17, 2019. 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-2017-E-6544 and FDA-2017-E-6542 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; IMFINZI.'' 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

[[Page 53068]]

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 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 IMFINZI
(durvalumab). IMFINZI is indicated for the treatment of patients with
locally advanced or metastatic urothelial carcinoma who have disease
progression during or following platinum-containing chemotherapy or who
have disease progression within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy. This indication is
approved under accelerated approval based on tumor response rate and
duration of response. 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 a
patent term restoration application for IMFINZI (U.S. Patent Nos.
8,779,108 and 9,493,565) from MedImmune Limited, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated, January 9, 2018, FDA
advised the USPTO that this human biological product had undergone a
regulatory review period and that the approval of IMFINZI 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
IMFINZI is 1,755 days. Of this time, 1,554 days occurred during the
testing phase of the regulatory review period, while 201 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 13,
2012. FDA has verified the applicant's claim that the date the initial
investigational new drug application became effective was on July 13,
2012.
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): October 13, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
IMFINZI (BLA 761069) was initially submitted on October 13, 2016.
3. The date the application was approved: May 1, 2017. FDA has
verified the applicant's claim that BLA 761069 was approved on May 1,
2017.
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 159 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: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22806 Filed 10-18-18; 8:45 am]
BILLING CODE 4164-01-P

53068 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices

review by FDA before the item was II. Determination of Regulatory Review Submit petitions electronically to
marketed. Under these acts, a product’s Period https://www.regulations.gov at Docket
regulatory review period forms the basis No. FDA–2013–S–0610. Submit written
FDA has determined that the
for determining the amount of extension petitions (two copies are required) to the
applicable regulatory review period for
an applicant may receive. IMFINZI is 1,755 days. Of this time, Dockets Management Staff (HFA–305),
A regulatory review period consists of 1,554 days occurred during the testing Food and Drug Administration, 5630
two periods of time: a testing phase and phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD
an approval phase. For human while 201 days occurred during the 20852.
biological products, the testing phase approval phase. These periods of time Dated: October 15, 2018.
begins when the exemption to permit were derived from the following dates: Leslie Kux,
the clinical investigations of the 1. The date an exemption under
Associate Commissioner for Policy.
biological product becomes effective section 505(i) of the Federal Food, Drug,
[FR Doc. 2018–22806 Filed 10–18–18; 8:45 am]
and runs until the approval phase and Cosmetic Act (21 U.S.C. 355(i))
begins. The approval phase starts with became effective: July 13, 2012. FDA has BILLING CODE 4164–01–P
the initial submission of an application verified the applicant’s claim that the
to market the human biological product date the initial investigational new drug
and continues until FDA grants application became effective was on DEPARTMENT OF HEALTH AND
permission to market the biological July 13, 2012. HUMAN SERVICES
product. Although only a portion of a 2. The date the application was
regulatory review period may count Food and Drug Administration
initially submitted with respect to the
toward the actual amount of extension human biological product under section
that the Director of USPTO may award 351 of the Public Health Service Act (42 [Docket No. FDA–2018–N–3761]
(for example, half the testing phase must U.S.C. 262): October 13, 2016. FDA has
be subtracted as well as any time that verified the applicant’s claim that the Sanofi-Aventis, U.S., LLC, et al.;
may have occurred before the patent biologics license application (BLA) for Withdrawal of Approval of 20 New
was issued), FDA’s determination of the IMFINZI (BLA 761069) was initially Drug Applications
length of a regulatory review period for submitted on October 13, 2016.
a human biological product will include 3. The date the application was AGENCY: Food and Drug Administration,
all of the testing phase and approval approved: May 1, 2017. FDA has HHS.
phase as specified in 35 U.S.C. verified the applicant’s claim that BLA ACTION: Notice.
156(g)(1)(B). 761069 was approved on May 1, 2017.
FDA has approved for marketing the This determination of the regulatory SUMMARY: The Food and Drug
human biologic product IMFINZI review period establishes the maximum Administration (FDA or Agency) is
(durvalumab). IMFINZI is indicated for potential length of a patent extension.
withdrawing approval of 20 new drug
the treatment of patients with locally However, the USPTO applies several
applications (NDAs) from multiple
advanced or metastatic urothelial statutory limitations in its calculations
applicants. The applicants notified the
carcinoma who have disease of the actual period for patent extension.
In its application for patent extension, Agency in writing that the drug
progression during or following
platinum-containing chemotherapy or this applicant seeks 159 days of patent products were no longer marketed and
who have disease progression within 12 term extension. requested that the approval of the
months of neoadjuvant or adjuvant applications be withdrawn.
III. Petitions
treatment with platinum-containing Approval is withdrawn as of
DATES:
chemotherapy. This indication is Anyone with knowledge that any of November 19, 2018.
approved under accelerated approval the dates as published are incorrect may
based on tumor response rate and submit either electronic or written FOR FURTHER INFORMATION CONTACT:
duration of response. Continued comments and, under 21 CFR 60.24, ask Florine P. Purdie, Center for Drug
approval for this indication may be for a redetermination (see DATES). Evaluation and Research, Food and
contingent upon verification and Furthermore, as specified in § 60.30 (21 Drug Administration, 10903 New
description of clinical benefit in CFR 60.30), any interested person may Hampshire Ave., Bldg. 51, Rm. 6248,
confirmatory trials. Subsequent to this petition FDA for a determination Silver Spring, MD 20993–0002, 301–
approval, the USPTO received a patent regarding whether the applicant for 796–3601.
term restoration application for IMFINZI extension acted with due diligence
(U.S. Patent Nos. 8,779,108 and during the regulatory review period. To SUPPLEMENTARY INFORMATION: The
9,493,565) from MedImmune Limited, meet its burden, the petition must applicants listed in the table have
and the USPTO requested FDA’s comply with all the requirements of informed FDA that these drug products
assistance in determining the patents’ § 60.30, including but not limited to: are no longer marketed and have
eligibility for patent term restoration. In must be timely (see DATES), must be requested that FDA withdraw approval
a letter dated, January 9, 2018, FDA filed in accordance with § 10.20, must of the applications under the process
advised the USPTO that this human contain sufficient facts to merit an FDA described in § 314.150(c) (21 CFR
amozie on DSK3GDR082PROD with NOTICES1

biological product had undergone a investigation, and must certify that a 314.150(c)). The applicants have also,
regulatory review period and that the true and complete copy of the petition by their requests, waived their
approval of IMFINZI represented the has been served upon the patent opportunity for a hearing. Withdrawal
first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th of approval of an application or
use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.) abbreviated application under
USPTO requested that FDA determine Petitions should be in the format § 314.150(c) is without prejudice to
the product’s regulatory review period. specified in 21 CFR 10.30. refiling.

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Document Created: 2018-10-19 01:25:34
Document Modified: 2018-10-19 01:25:34

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 December 18, 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 April 17, 2019. 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 53067

83 FR 53067 - Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 203 (October 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration