83 FR 5781 - Determination of Regulatory Review Period for Purposes of Patent Extension; ENTRESTO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range		5781-5783
FR Document		2018-02592

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENTRESTO 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 83 Issue 28 (Friday, February 9, 2018)

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5781-5783]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02592]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1851; FDA-2016-E-1878; FDA-2016-E-1879; FDA-
2016-E-1880; and FDA-2016-E-1882]

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

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 ENTRESTO 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 April
10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 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 5782]]

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-2016-E-1851; FDA-2016-E-1878; FDA-2016-E-1879; FDA-2016-E-1880; and
FDA-2016-E-1882 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ENTRESTO.'' 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 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 ENTRESTO
(sacubitril and valsartan). ENTRESTO is indicated to reduce the risk of
cardiovascular death and hospitalization for heart failure in patients
with chronic heart failure (New York Heart Association Class II-IV) and
reduced ejection fraction. Subsequent to this approval, the USPTO
received patent term restoration applications for ENTRESTO (U.S. Patent
Nos. 7,468,390; 8,101,659; 8,404,744; 8,796,331; and 8,877,938) from
Novartis Pharmaceuticals Corporation, and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated August 25, 2016, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of ENTRESTO 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
ENTRESTO is 3,148 days. Of this time, 2,945 days occurred during the
testing phase of the regulatory review period, while 203 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 25, 2006. Novartis Pharmaceuticals Corporation claims that
April 8, 2007, is the date the investigational new drug application
(IND) became effective. However, FDA records indicate that the IND
effective date was November 25,

[[Page 5783]]

2006, which was 30 days after FDA receipt of an earlier IND.
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
17, 2014. FDA has verified the applicant's claim that the new drug
application (NDA) for ENTRESTO (NDA 207620) was initially submitted on
December 17, 2014.
3. The date the application was approved: July 7, 2015. FDA has
verified the applicant's claim that NDA 207620 was approved on July 7,
2015.
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 1,296 days, 732 days, 519 days, 270 days or 225
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 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02592 Filed 2-8-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5781

so long as the patented item (human 1. The date an exemption under Dated: February 6, 2018.
drug product, animal drug product, section 505(i) of the Federal Food, Drug, Leslie Kux,
medical device, food additive, or color and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
additive) was subject to regulatory U.S.C. 355(i)) became effective: [FR Doc. 2018–02658 Filed 2–8–18; 8:45 am]
review by FDA before the item was December 15, 2008. FDA has verified BILLING CODE 4164–01–P
marketed. Under these acts, a product’s the applicant’s claim that December 15,
regulatory review period forms the basis 2008, is the date the investigational new
for determining the amount of extension drug application (IND) became effective. DEPARTMENT OF HEALTH AND
an applicant may receive. HUMAN SERVICES
A regulatory review period consists of 2. The date the application was
two periods of time: A testing phase and initially submitted with respect to the Food and Drug Administration
an approval phase. For human drug human drug product under section
[Docket Nos. FDA–2016–E–1851; FDA–
products, the testing phase begins when 505(b) of the FD&C Act: September 26, 2016–E–1878; FDA–2016–E–1879; FDA–
the exemption to permit the clinical 2014. FDA has verified the applicant’s 2016–E–1880; and FDA–2016–E–1882]
investigations of the drug becomes claim that the new drug application
effective and runs until the approval (NDA) for ODOMZO (NDA 205266) was Determination of Regulatory Review
phase begins. The approval phase starts initially submitted on September 26, Period for Purposes of Patent
with the initial submission of an 2014. Extension; ENTRESTO
application to market the human drug
3. The date the application was AGENCY: Food and Drug Administration,
product and continues until FDA grants
permission to market the drug product. approved: July 24, 2015. FDA has HHS.
Although only a portion of a regulatory verified the applicant’s claim that NDA ACTION: Notice.
review period may count toward the 205266 was approved on July 24, 2015.
SUMMARY: The Food and Drug
actual amount of extension that the This determination of the regulatory Administration (FDA or the Agency) has
Director of USPTO may award (for review period establishes the maximum determined the regulatory review period
example, half the testing phase must be potential length of a patent extension. for ENTRESTO and is publishing this
subtracted as well as any time that may However, the USPTO applies several notice of that determination as required
have occurred before the patent was statutory limitations in its calculations by law. FDA has made the
issued), FDA’s determination of the of the actual period for patent extension. determination because of the
length of a regulatory review period for In its application for patent extension, submission of applications to the
a human drug product will include all this applicant seeks 169 days of patent Director of the U.S. Patent and
of the testing phase and approval phase term extension. Trademark Office (USPTO), Department
as specified in 35 U.S.C. 156(g)(1)(B). of Commerce, for the extension of a
FDA has approved for marketing the III. Petitions patent which claims that human drug
human drug product ODOMZO product.
(sonidegib phosphate). ODOMZO is Anyone with knowledge that any of
indicated for the treatment of adult the dates as published are incorrect may DATES: Anyone with knowledge that any
patients with locally advanced basal cell submit either electronic or written of the dates as published (in the
carcinoma that has recurred following comments and, under 21 CFR 60.24, ask SUPPLEMENTARY INFORMATION section) are
surgery or radiation therapy, or those for a redetermination (see DATES). incorrect may submit either electronic
who are not candidates for surgery or Furthermore, as specified in § 60.30 (21 or written comments and ask for a
radiation therapy. Subsequent to this CFR 60.30), any interested person may redetermination by April 10, 2018.
approval, the USPTO received a patent petition FDA for a determination Furthermore, any interested person may
term restoration application for regarding whether the applicant for petition FDA for a determination
ODOMZO (U.S. Patent No. 8,178,563) extension acted with due diligence regarding whether the applicant for
from Novartis AG, and the USPTO during the regulatory review period. To extension acted with due diligence
requested FDA’s assistance in during the regulatory review period by
meet its burden, the petition comply
determining this patent’s eligibility for August 8, 2018. See ‘‘Petitions’’ in the
with all the requirements of § 60.30,
patent term restoration. In a letter dated SUPPLEMENTARY INFORMATION section for
including but not limited to: Must be
July 28, 2016, FDA advised the USPTO more information.
timely (see DATES), must be filed in
that this human drug product had ADDRESSES: You may submit comments
accordance with § 10.20, must contain
undergone a regulatory review period as follows. Please note that late,
sufficient facts to merit an FDA
and that the approval of ODOMZO untimely filed comments will not be
represented the first permitted investigation, and must certify that a considered. Electronic comments must
commercial marketing or use of the true and complete copy of the petition be submitted on or before April 10,
product. Thereafter, the USPTO has been served upon the patent 2018. The https://www.regulations.gov
requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th electronic filing system will accept
product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) comments until midnight Eastern Time
Petitions should be in the format at the end of April 10, 2018. Comments
II. Determination of Regulatory Review specified in 21 CFR 10.30. received by mail/hand delivery/courier
Period
Submit petitions electronically to (for written/paper submissions) will be
FDA has determined that the
sradovich on DSK3GMQ082PROD with NOTICES

https://www.regulations.gov at Docket considered timely if they are
applicable regulatory review period for No. FDA–2013–S–0610. Submit written postmarked or the delivery service
ODOMZO is 2,414 days. Of this time, acceptance receipt is on or before that
petitions (two copies are required) to the
2,112 days occurred during the testing date.
Dockets Management Staff (HFA–305),
phase of the regulatory review period,
Food and Drug Administration, 5630 Electronic Submissions
while 302 days occurred during the
approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the
were derived from the following dates: 20852. following way:

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Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5783

2006, which was 30 days after FDA Dated: February 5, 2018. Dispute Resolution Procedures for
receipt of an earlier IND. Leslie Kux, Science-Based Decisions on Products
2. The date the application was Associate Commissioner for Policy. Regulated by the Center for Veterinary
initially submitted with respect to the [FR Doc. 2018–02592 Filed 2–8–18; 8:45 am] Medicine—21 CFR 10.75
human drug product under section BILLING CODE 4164–01–P OMB Control Number 0910–0566—
505(b) of the FD&C Act: December 17, Extension
2014. FDA has verified the applicant’s
claim that the new drug application DEPARTMENT OF HEALTH AND The Center for Veterinary Medicine’s
(NDA) for ENTRESTO (NDA 207620) HUMAN SERVICES (CVM’s) Guidance for Industry (GIF)
was initially submitted on December 17, #79, ‘‘Dispute Resolution Procedures for
2014. Food and Drug Administration Science-Based Decisions on Products
[Docket No. FDA–2017–N–6145] Regulated by the Center for Veterinary
3. The date the application was
Medicine’’ (https://www.fda.gov/
approved: July 7, 2015. FDA has verified
Agency Information Collection downloads/AnimalVeterinary/Guidance
the applicant’s claim that NDA 207620
Activities; Submission for Office of ComplianceEnforcement/Guidancefor
was approved on July 7, 2015.
Management and Budget Review; Industry/UCM052393.pdf), describes the
This determination of the regulatory Comment Request; Dispute Resolution process by which CVM formally
review period establishes the maximum Procedures for Science-Based resolves disputes relating to scientific
potential length of a patent extension. Decisions on Products Regulated by controversies. A scientific controversy
However, the USPTO applies several the Center for Veterinary Medicine involves issues concerning a specific
statutory limitations in its calculations product regulated by CVM related to
of the actual period for patent extension. AGENCY: Food and Drug Administration, matters of technical expertise and
In its applications for patent extension, HHS. requires specialized education, training,
this applicant seeks 1,296 days, 732 ACTION: Notice. or experience to be understood and
days, 519 days, 270 days or 225 days of resolved. The guidance details
patent term extension. SUMMARY: The Food and Drug
Administration (FDA) is announcing information on how CVM intends to
III. Petitions that a proposed collection of apply provisions of existing regulations
information has been submitted to the regarding internal review of Agency
Anyone with knowledge that any of Office of Management and Budget decisions. In addition, the guidance
the dates as published are incorrect may (OMB) for review and clearance under outlines the established procedures for
submit either electronic or written the Paperwork Reduction Act of 1995. persons who are sponsors, applicants, or
comments and, under 21 CFR 60.24, ask manufacturers of animal drugs or other
DATES: Fax written comments on the
for a redetermination (see DATES). products regulated by CVM that wish to
collection of information by March 12,
Furthermore, as specified in § 60.30 (21 submit a request for review of a
2018.
CFR 60.30), any interested person may scientific dispute. When a sponsor,
petition FDA for a determination ADDRESSES: To ensure that comments on
applicant, or manufacturer has a
regarding whether the applicant for the information collection are received,
scientific disagreement with a written
extension acted with due diligence OMB recommends that written
decision by CVM, they may submit a
during the regulatory review period. To comments be faxed to the Office of
Information and Regulatory Affairs, request for a review of that decision by
meet its burden, the petition must following the established procedures
comply with all the requirements of OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_ discussed in the guidance.
§ 60.30, including but not limited to: CVM encourages applicants to begin
Must be timely (see DATES), must be submission@omb.eop.gov. All
comments should be identified with the the resolution of science-based disputes
filed in accordance with § 10.20, must with discussions with the review team/
contain sufficient facts to merit an FDA OMB control number 0910–0566. Also
include the FDA docket number found group, including the Team Leader or
investigation, and must certify that a Division Director. The Center prefers
true and complete copy of the petition in brackets in the heading of this
document. that differences of opinion regarding
has been served upon the patent science or science-based policy be
applicant. (See H. Rept. 857, part 1, 98th FOR FURTHER INFORMATION CONTACT: Ila resolved between the review team/group
Cong., 2d sess., pp. 41–42, 1984.) S. Mizrachi, Office of Operations, Food and the applicant. If the matter is not
Petitions should be in the format and Drug Administration, Three White resolved by this preferred method then
specified in 21 CFR 10.30. Flint North, 10A–12M, 11601 CVM recommends that the applicant
Submit petitions electronically to Landsdown St., North Bethesda, MD follow the procedures in GFI #79.
https://www.regulations.gov at Docket 20852, 301–796–7726, PRAStaff@ In the Federal Register of October 27,
No. FDA–2013–S–0610. Submit written fda.hhs.gov. 2017 (82 FR 49836), FDA published a
petitions (two copies are required) to the SUPPLEMENTARY INFORMATION: In 60-day notice requesting public
Dockets Management Staff (HFA–305), compliance with 44 U.S.C. 3507, FDA comment on the proposed collection of
Food and Drug Administration, 5630 has submitted the following proposed information. We received no comments.
Fishers Lane, Rm. 1061, Rockville, MD collection of information to OMB for FDA estimates the burden of this
20852. review and clearance. collection of information as follows:
sradovich on DSK3GMQ082PROD with NOTICES

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Document Created: 2018-02-09 00:11:43
Document Modified: 2018-02-09 00:11:43

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 April 10, 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 8, 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 5781

83 FR 5781 - Determination of Regulatory Review Period for Purposes of Patent Extension; ENTRESTO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration