83 FR 54108 - Determination of Regulatory Review Period for Purposes of Patent Extension; TALTZ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 208 (October 26, 2018)

Page Range		54108-54110
FR Document		2018-23438

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TALTZ 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 208 (Friday, October 26, 2018)

[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54108-54110]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-23438]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-4274; FDA-2016-E-3887]

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

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 TALTZ 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 26, 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 24,
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 December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 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.

Electronic Submissions

Submit electronic comments in the following way:

[[Page 54109]]

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-4274 and FDA-2016-E-3887 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; TALTZ.'' 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.
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 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 TALTZ
(ixekizumab). TALTZ is indicated for treatment of adults with moderate-
to-severe plaque psoriasis who are candidates for systemic therapy or
phototherapy. Subsequent to this approval, the USPTO received patent
term restoration applications for TALTZ (U.S. Patent Nos. 7,838,638 and
8,110,191) from Eli Lilly and Company, and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated September 20, 2017, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of TALTZ 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
TALTZ is 3,036 days. Of this time, 2,670 days occurred during the
testing phase of the regulatory review period, while 366 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: December 1,
2007. The applicant claims December 2, 2007, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was December 1, 2007,
which was 30 days after FDA receipt of the IND.
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

[[Page 54110]]

U.S.C. 262): March 23, 2015. FDA has verified the applicant's claim
that the biologics license application (BLA) for TALTZ (BLA 125521) was
initially submitted on March 23, 2015.
3. The date the application was approved: March 22, 2016. FDA has
verified the applicant's claim that BLA 125521 was approved on March
22, 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 applications for patent extension,
this applicant seeks 1,156 days or 935 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 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23438 Filed 10-25-18; 8:45 am]
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54108 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices

You may submit comments on any European Commission; the European RegulatoryInformation/Guidances/
guidance at any time (see 21 CFR Federation of Pharmaceutical Industries default.htm.
10.115(g)(5)). Associations; FDA; the Japanese Dated: October 22, 2018.
Submit written requests for single Ministry of Health, Labour, and Welfare; Leslie Kux,
copies of this guidance to the Division the Japanese Pharmaceutical
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of Drug Information, Center for Drug Manufacturers Association; and the
[FR Doc. 2018–23425 Filed 10–25–18; 8:45 am]
Evaluation and Research, Food and Pharmaceutical Research and
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Hampshire Ave., Hillandale Building, Standing Members of the ICH
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HUMAN SERVICES
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(CBER), Food and Drug Administration, membership in writing to the ICH
10903 New Hampshire Ave., Bldg. 71, Secretariat. The ICH Secretariat, which [Docket Nos. FDA–2017–E–4274; FDA–
coordinates the preparation of 2016–E–3887]
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive documentation, operates as an
Determination of Regulatory Review
label to assist that office in processing international nonprofit organization and
Period for Purposes of Patent
your requests. The guidance may also be is funded by the Members of the ICH
Extension; TALTZ
obtained by mail by calling CBER at 1– Association.
800–835–4709 or 240–402–8010. See The ICH Assembly is the overarching AGENCY: Food and Drug Administration,
the SUPPLEMENTARY INFORMATION section body of the Association and includes HHS.
for electronic access to the guidance representatives from each of the ICH ACTION: Notice.
document. members and observers. The Assembly
is responsible for the endorsement of SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: Administration (FDA or the Agency) has
draft guidelines and adoption of final
Regarding the guidance: Mehul guidelines. FDA publishes ICH determined the regulatory review period
Mehta, Center for Drug Evaluation and guidelines as FDA guidance. for TALTZ and is publishing this notice
Research, Food and Drug In May 2018, the ICH Assembly of that determination as required by
Administration, Bldg. 51, Rm. 2178, endorsed the draft guideline entitled law. FDA has made the determination
10903 New Hampshire Ave., Silver ‘‘Biopharmaceutics Classification because of the submission of
Spring, MD 20993–0002, 301–796–1573. System-Based Biowaivers’’ and agreed applications to the Director of the U.S.
Regarding the ICH: Amanda Roache, that the guideline should be made Patent and Trademark Office (USPTO),
Center for Drug Evaluation and available for public comment. The draft Department of Commerce, for the
Research, Food and Drug guideline is the product of the extension of a patent which claims that
Administration, 10903 New Hampshire Multidisciplinary M9 Expert Working human biological product.
Ave., Bldg. 51, Rm. 1176, Silver Spring, Group of the ICH. Comments about this DATES: Anyone with knowledge that any
MD 20993–0002, 301–796–4548. draft will be considered by FDA and the of the dates as published (in the
SUPPLEMENTARY INFORMATION: Multidisciplinary M9 Expert Working SUPPLEMENTARY INFORMATION section) are
I. Background Group. incorrect may submit either electronic
The draft guidance provides guidance or written comments and ask for a
In recent years, regulatory authorities on the biopharmaceutics classification redetermination by December 26, 2018.
and industry associations from around of drug substances and the BCS-based Furthermore, any interested person may
the world have participated in many waiver of in vivo BE studies for drug petition FDA for a determination
important initiatives to promote products. regarding whether the applicant for
international harmonization of This draft guidance is being issued extension acted with due diligence
regulatory requirements under the ICH. consistent with FDA’s good guidance during the regulatory review period by
FDA has participated in several ICH practices regulation (21 CFR 10.115). April 24, 2019. See ‘‘Petitions’’ in the
meetings designed to enhance The draft guidance, when finalized, will SUPPLEMENTARY INFORMATION section for
harmonization, and FDA is committed represent the current thinking of FDA more information.
to seeking scientifically based on ‘‘Biopharmaceutics Classification ADDRESSES: You may submit comments
harmonized technical procedures for System-Based Biowaivers.’’ It does not as follows. Please note that late,
pharmaceutical development. One of establish any rights for any person and untimely filed comments will not be
the goals of harmonization is to identify is not binding on FDA or the public. considered. Electronic comments must
and reduce differences in technical You can use an alternative approach if be submitted on or before December 26,
requirements for drug development it satisfies the requirements of the 2018. The https://www.regulations.gov
among regulatory Agencies. applicable statutes and regulations. This electronic filing system will accept
ICH was established to provide an guidance is not subject to Executive comments until 11:59 p.m. Eastern Time
opportunity for harmonization Order 12866. at the end of December 26, 2018.
initiatives to be developed with input Comments received by mail/hand
from both regulatory and industry II. Electronic Access
delivery/courier (for written/paper
representatives. FDA also seeks input Persons with access to the internet
khammond on DSK30JT082PROD with NOTICES

submissions) will be considered timely
from consumer representatives and may obtain the draft guidance at https:// if they are postmarked or the delivery
others. ICH is concerned with www.fda.gov/Drugs/ service acceptance receipt is on or
harmonization of technical GuidanceComplianceRegulatory before that date.
requirements for the registration of Information/Guidances/default.htm,
pharmaceutical products for human use https://www.regulations.gov, or https:// Electronic Submissions
among regulators around the world. The www.fda.gov/BiologicsBloodVaccines/ Submit electronic comments in the
six founding members of the ICH are the GuidanceCompliance following way:

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Document Created: 2018-10-26 02:28:00
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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 December 26, 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 24, 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 54108

83 FR 54108 - Determination of Regulatory Review Period for Purposes of Patent Extension; TALTZ

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 208 (October 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration