83 FR 53476 - Determination of Regulatory Review Period for Purposes of Patent Extension; SILIQ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 205 (October 23, 2018)

Page Range		53476-53478
FR Document		2018-23058

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SILIQ 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 205 (Tuesday, October 23, 2018)

[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53476-53478]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-23058]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-5940, FDA-2017-E-5941, FDA-2017-E-5943, and
FDA-2017-E-5944]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SILIQ 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 24, 2018. Furthermore, any interested person may petition FDA
for a determination

[[Page 53477]]

regarding whether the applicant for extension acted with due diligence
during the regulatory review period by April 22, 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 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 24, 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-2017-E-5940, FDA-2017-E-5941, FDA-2017-E-5943, and FDA-2017-E-5944
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; SILIQ.'' 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 SILIQ
(brodalumab). SILIQ is indicated for treatment of moderate to severe
plaque psoriasis in adult patients who are candidates for systemic
therapy or phototherapy and have failed to respond or have lost
response to other systemic therapies. Subsequent to this approval, the
USPTO received patent term restoration applications for SILIQ (U.S.
Patent Nos. 7,767,206; 7,939,070; 8,435,518; and 8,545,842) from Kirin-
Amgen, Inc., 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 SILIQ represented the first permitted commercial marketing or use of
the

[[Page 53478]]

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
SILIQ is 3,101 days. Of this time, 2,643 days occurred during the
testing phase of the regulatory review period, while 458 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: August 22,
2008. The applicant claims September 26, 2009, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 22, 2008,
which was 30 days after FDA receipt of an earlier 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 U.S.C. 262): November 16, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
SILIQ (BLA 761032) was initially submitted on November 16, 2015.
3. The date the application was approved: February 15, 2017. FDA
has verified the applicant's claim that BLA 761032 was approved on
February 15, 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 applications for patent extension,
this applicant seeks 1,156 days, 906 days, or 847 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 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23058 Filed 10-22-18; 8:45 am]
BILLING CODE 4164-01-P

53476 Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices

federal IT platform (i.e., Financial Management and Exchange planning and implementing the
HealthCare.gov). HHS anticipates that Operations; Use: As directed by the rule insurance market reforms and consumer
consumers may use this information to Establishment of Exchanges and protections under Part A of title XXVII
inform plan selection. Qualified Health Plans; Exchange of the Public Health Service Act (PHS
As stated in the final rule Patient Standards for Employers (77 FR 18310) Act). States that are awarded funds
Protection and Affordable Care Act; (Exchange rule), each Exchange is under this funding opportunity are
Establishment of Exchanges and responsible for the certification and required to provide CMS with four
Qualified Health Plans; Exchange offering of Qualified Health Plans quarterly reports and one annual report
Standards for Employers (77 FR 18310; (QHPs). To offer insurance through an (except for the last year of the grant)
March 27, 2012), broader Exchange, a health insurance issuer until the end of the grant period
implementation will continue to be must have its health plans certified as detailing the state’s progression towards
addressed in separate rulemaking issued QHPs by the Exchange. A QHP must planning and/or implementing the pre-
by HHS, and the Departments of Labor meet certain minimum certification selected market reforms under Part A of
and the Treasury (the Departments). standards, such as network adequacy, Title XXVII of the PHS Act. A final
Consistent with Public Health Service inclusion of Essential Community report is due at the end of the grant
Act (PHS Act) 1 section 2715A, which Providers (ECPs), and non- period. Form Number: CMS–10657
largely extends the transparency discrimination. The Exchange is (OMB control number: 0938–NEW);
reporting provisions set forth in section responsible for ensuring that QHPs meet Frequency: Annually and Quarterly;
1311(e)(3) to non-grandfathered group these minimum certification standards Affected Public: State, Local or Tribal
health plans (including large group and as described in the Exchange rule under Governments; Number of Respondents:
self-insured health plans) and health 45 CFR 155 and 156, based on the 31; Total Annual Responses: 5; Total
insurance issuers offering group and Patient Protection and Affordable Care Annual Hours: 2,108. (For policy
individual health insurance coverage Act (PPACA), as well as other standards questions regarding this collection
(non-QHP issuers), the Departments determined by the Exchange. Issuers can contact Jim Taing at (301) 492–4182.)
intend to propose other transparency offer individual and small group market Dated: October 17, 2018.
reporting requirements at a later time, plans outside of the Exchanges that are William N. Parham, III,
through a separate rulemaking not QHPs.
The instruments in this information Director, Paperwork Reduction Staff. Office
conducted by the Departments, for non- of Strategic Operations and Regulatory
QHP issuers and non-grandfathered collection will be used for the 2020 Affairs.
group health plans. Those proposed certification process and beyond.
[FR Doc. 2018–23027 Filed 10–22–18; 8:45 am]
reporting requirements may differ from Providing these instruments now will
BILLING CODE 4120–01–P
those prescribed in the HHS proposal give issuers and other stakeholders more
under section 1311(e)(3), and will take opportunity to familiarize themselves
into account differences in markets, with the instruments before releasing
DEPARTMENT OF HEALTH AND
reporting requirements already in the 2020 application. Form Number:
HUMAN SERVICES
existence for non-QHPs (including CMS–10433 (OMB control number:
group health plans), and other relevant 0938–1187); Frequency: Annually; Food and Drug Administration
factors. The Departments also intend to Affected Public: State, Local, or Tribal
Governments, Private Sector (Business [Docket Nos. FDA–2017–E–5940, FDA–
streamline reporting under multiple 2017–E–5941, FDA–2017–E–5943, and FDA–
reporting provisions and reduce or other for-profits); Number of
2017–E–5944]
unnecessary duplication. The Respondents: 2,892 Number of
Departments intend to implement any Responses: 2,892; Total Annual Hours: Determination of Regulatory Review
transparency reporting requirements 68,666. (For questions regarding this Period for Purposes of Patent
applicable to non-QHP issuers and non- collection contact Joshua Annas at (301) Extension; SILIQ
grandfathered group health plans only 492–4407).
6. Type of Information Collection AGENCY: Food and Drug Administration,
after notice and comment, and after HHS.
Request: Request for a new OMB control
giving those issuers and plans sufficient
number; Title of Information Collection: ACTION: Notice.
time, following the publication of final
The State Flexibility to Stabilize the
rules, to come into compliance with SUMMARY: The Food and Drug
Market Grant Program Reporting; Use:
those requirements. Form Number: Administration (FDA or the Agency) has
Section 1003 of the Affordable Care Act
CMS–10572 (OMB control number: (ACA) adds a new section 2794 to the determined the regulatory review period
0938–1310); Frequency: Annually; PHS Act entitled, ‘‘Ensuring That for SILIQ and is publishing this notice
Affected Public: Private Sector (Business Consumers Get Value for Their Dollars.’’ of that determination as required by
or other for-profits); Number of Specifically, section 2794(a) requires the law. FDA has made the determination
Respondents: 160; Number of Secretary of the Department of Health because of the submission of
Responses: 160; Total Annual Hours: and Human Services (the Secretary) applications to the Director of the U.S.
10,880. (For questions regarding this (HHS), in conjunction with the States, to Patent and Trademark Office (USPTO),
collection contact Valisha Jackson at establish a process for the annual review Department of Commerce, for the
(301) 492–5145.) of health insurance premiums to protect extension of a patent which claims that
5. Type of Information Collection consumers from unreasonable rate human biological product.
Request: Revision of a currently increases. Section 2794(c) directs the DATES: Anyone with knowledge that any
khammond on DSK30JT082PROD with NOTICES

approved collection; Title of Secretary to carry out a program to of the dates as published (see the
Information Collection: Data Collection award grants to States. Section SUPPLEMENTARY INFORMATION section) are
to Support QHP Certification and other 2794(c)(2)(B) specifies that any incorrect may submit either electronic
1 PHS Act section 2715A also is incorporated into
appropriated Rate Review Grant funds or written comments and ask for a
section 715(a)(1) of the Employee Retirement
that are not fully obligated by the end redetermination by December 24, 2018.
Income Security Act and section 9815(a)(1) of the of FY 2014 shall remain available to the Furthermore, any interested person may
Internal Revenue Code. Secretary for grants to States for petition FDA for a determination

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Document Created: 2018-10-23 04:14:56
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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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 24, 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 22, 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 53476

83 FR 53476 - Determination of Regulatory Review Period for Purposes of Patent Extension; SILIQ

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 205 (October 23, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration