83 FR 4661 - Determination of Regulatory Review Period for Purposes of Patent Extension; CORLANOR

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 22 (February 1, 2018)

Page Range		4661-4663
FR Document		2018-01979

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CORLANOR 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 22 (Thursday, February 1, 2018)

[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Notices]
[Pages 4661-4663]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01979]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1234 and FDA-2016-E-1257]

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

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 CORLANOR 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
2, 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 July 31, 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 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 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

[[Page 4662]]

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-1234 and FDA-2016-E-1257 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; CORLANOR.'' 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 CORLANOR
(ivabradine hydrochloride). CORLANOR is indicated to reduce the risk of
hospitalization for worsening heart failure in patients with stable,
symptomatic chronic heart failure with left ventricular ejection
fraction <= 35% who are in sinus rhythm with resting heart rate >= 70
beats per minute and either are on maximally tolerated doses of beta-
blockers or have a contraindication to beta-blocker use. Subsequent to
this approval, the USPTO received a patent term restoration application
for CORLANOR (U.S. Patent Nos. 7,879,842 and 7,867,996) from Les
Laboratoires Servier, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated July 28, 2016, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of CORLANOR 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
CORLANOR is 293 days. Of this time, 0 days occurred during the testing
phase of the regulatory review period, while 293 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: No exemption claimed. FDA has verified the Les Laboratoires
Servier claim that they did not file an investigational new drug
application (IND) with FDA.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 27,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for CORLANOR (NDA 206143) was initially submitted on
June 27, 2014.

[[Page 4663]]

3. The date the application was approved: April 15, 2015. FDA has
verified the applicant's claim that NDA 206143 was approved on April
15, 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 292 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 Nos. 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: January 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01979 Filed 1-31-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices 4661

(e.g., response evaluation criteria in III. Registration and Accommodations DEPARTMENT OF HEALTH AND
solid tumors-based endpoints (RECIST)) HUMAN SERVICES
has become an active area of research. Registration: Persons interested in
Alternative metrics that require shorter attending this public workshop must Food and Drug Administration
periods of observation or provide more register online by January 31, 2018, at
https://fdaoce.formstack.com/forms/ [Docket Nos. FDA–2016–E–1234 and FDA–
precise assessment of treatment effects 2016–E–1257]
could lead to more rapid completion of isop. Please provide complete contact
clinical trials and require fewer patients. information for each attendee, including Determination of Regulatory Review
Promising among these alternative name, title, affiliation, address, email, Period for Purposes of Patent
metrics are model-based metrics, such and telephone number. Extension; CORLANOR
as those based on longitudinal Registration is free and based on
continuous tumor size measurements. AGENCY: Food and Drug Administration,
space availability, with priority given to HHS.
Additionally, model-informed early registrants. Early registration is
approaches can help satisfy a need to ACTION: Notice.
recommended because seating is
optimize dosing regimens for patients.
limited; therefore, FDA may limit the SUMMARY: The Food and Drug
Investigations to refine dosing regimens
number of participants from each Administration (FDA or the Agency) has
often occur after new drug approval
and/or are driven by pharmacometric organization. Registrants will receive determined the regulatory review period
modeling approaches. There is growing confirmation when they have been for CORLANOR and is publishing this
interest in using model-informed accepted. If time and space permit, notice of that determination as required
approaches to help balance the risks and onsite registration on the day of the by law. FDA has made the
benefits of oncology products by public workshop will be provided determination because of the
identifying optimal dosing regimens, beginning at 8 a.m. submission of applications to the
and broad stakeholder engagement and If you need special accommodations Director of the U.S. Patent and
discussion around this topic can be due to a disability, please contact Trademark Office (USPTO), Department
beneficial. of Commerce, for the extension of a
Yvonne Knight (see FOR FURTHER
patent which claims that human drug
II. Objectives INFORMATION CONTACT) no later than
product.
January 24, 2018.
The objectives of the workshop are to: DATES: Anyone with knowledge that any
Streaming Webcast of the Public
1. Discuss ‘‘best practices’’ in of the dates as published (in the
Workshop: The meeting will also be
integrating human pharmacokinetic, SUPPLEMENTARY INFORMATION section) are
webcast. A live webcast of this
pharmacodynamic, efficacy, and safety incorrect may submit either electronic
workshop will be available at https:// or written comments and ask for a
data into models that best inform collaboration.fda.gov/fdaisop/ on the
oncology drug development. redetermination by April 2, 2018.
day of the workshop. If you have never Furthermore, any interested person may
2. Describe novel imaging techniques attended a Connect Pro event before,
and diagnostic and predictive petition FDA for a determination
test your connection at https:// regarding whether the applicant for
biomarkers that may be utilized in collaboration.fda.gov/common/help/en/
oncology drug development. extension acted with due diligence
support/meeting_test.htm. To get a during the regulatory review period by
3. Describe disease- and mechanism- quick overview of the Connect Pro July 31, 2018. See ‘‘Petitions’’ in the
specific early endpoints to predict long- program, visit https://www.adobe.com/ SUPPLEMENTARY INFORMATION section for
term efficacy. go/connectpro_overview. FDA has more information.
4. Evaluate the potential to shift from verified the website addresses in this ADDRESSES: You may submit comments
traditional RECIST-based endpoints document, as of the date this document as follows. Please note that late,
such as Overall Response Rate (ORR) publishes in the Federal Register, but untimely filed comments will not be
and Progression Free Survival (PFS) to websites are subject to change over time. considered. Electronic comments must
modified RECIST approaches (e.g.,
Transcripts: Please be advised that as be submitted on or before April 2, 2018.
imRECIST for immunotherapies) as well
soon as a transcript of the public The https://www.regulations.gov
as to other (model-based) tumor kinetic
workshop is available, it will be electronic filing system will accept
metrics to support early decision
accessible at https:// comments until midnight Eastern Time
making in Phase 1/2 as well as in
FDAOCE.formstack.com/forms/isop. It at the end of April 2, 2018. Comments
confirmatory trials.
may be viewed at the Dockets received by mail/hand delivery/courier
5. Discuss potential regulatory (for written/paper submissions) will be
implications of model-informed Management Staff (HFA–305), Food and
considered timely if they are
decisions in drug development, Drug Administration, 5630 Fishers
postmarked or the delivery service
including, model-based target Lane, Rm. 1061, Rockville, MD 20852. acceptance receipt is on or before that
identification, dose/exposure Dated: January 29, 2018. date.
justification based on preclinical Leslie Kux,
evidence, dose selection for first-in- Electronic Submissions
Associate Commissioner for Policy.
human trials, quality by design, early Submit electronic comments in the
clinical study design, dose finding/ [FR Doc. 2018–01992 Filed 1–31–18; 8:45 am]
following way:
sradovich on DSK3GMQ082PROD with NOTICES

titration, confirmatory trials, product BILLING CODE 4164–01–P
• Federal eRulemaking Portal:
labeling, and post-marketing studies. https://www.regulations.gov. Follow the
A detailed agenda will be posted on instructions for submitting comments.
the following website in advance of the Comments submitted electronically,
workshop: https://www.fda.gov/ including attachments, to https://
downloads/Drugs/NewsEvents/ www.regulations.gov will be posted to
UCM589458.pdf. the docket unchanged. Because your

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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices 4663

3. The date the application was SUMMARY: HRSA is publishing this Section 2112(b)(2) of the PHS Act, 42
approved: April 15, 2015. FDA has notice of petitions received under the U.S.C. 300aa–12(b)(2), requires that
verified the applicant’s claim that NDA National Vaccine Injury Compensation ‘‘[w]ithin 30 days after the Secretary
206143 was approved on April 15, 2015. Program (the program), as required by receives service of any petition filed
This determination of the regulatory the Public Health Service (PHS) Act, as under section 2111, the Secretary shall
review period establishes the maximum amended. While the Secretary of HHS publish notice of such petition in the
potential length of a patent extension. (the Secretary) is named as the Federal Register.’’ Set forth below is a
However, the USPTO applies several respondent in all proceedings brought list of petitions received by HRSA on
statutory limitations in its calculations by the filing of petitions for December 1, 2017, through December
of the actual period for patent extension. compensation under the Program, the 31, 2017. This list provides the name of
In its applications for patent extension, United States Court of Federal Claims is petitioner, city and state of vaccination
this applicant seeks 292 days of patent charged by statute with responsibility (if unknown then city and state of
term extension. for considering and acting upon the person or attorney filing claim), and
petitions. case number. In cases where the Court
III. Petitions has redacted the name of a petitioner
FOR FURTHER INFORMATION CONTACT: For
Anyone with knowledge that any of information about requirements for and/or the case number, the list reflects
the dates as published are incorrect may filing petitions, and the program in such redaction.
submit either electronic or written general, contact Lisa L. Reyes, Acting Section 2112(b)(2) also provides that
comments and, under 21 CFR 60.24, ask Clerk, United States Court of Federal the special master ‘‘shall afford all
for a redetermination (see DATES). Claims, 717 Madison Place NW, interested persons an opportunity to
Furthermore, as specified in § 60.30 (21 Washington, DC 20005, (202) 357–6400. submit relevant, written information’’
CFR 60.30), any interested person may For information on HRSA’s role in the relating to the following:
petition FDA for a determination program, contact the Director, National 1. The existence of evidence ‘‘that
regarding whether the applicant for Vaccine Injury Compensation Program, there is not a preponderance of the
extension acted with due diligence 5600 Fishers Lane, Room 08N146B, evidence that the illness, disability,
during the regulatory review period. To Rockville, MD 20857; (301) 443–6593, injury, condition, or death described in
meet its burden, the petition must or visit our website at: http:// the petition is due to factors unrelated
comply with all the requirements of www.hrsa.gov/vaccinecompensation/ to the administration of the vaccine
§ 60.30, including but not limited to: index.html. described in the petition,’’ and
Must be timely (see DATES), must be SUPPLEMENTARY INFORMATION: The 2. Any allegation in a petition that the
filed in accordance with § 10.20, must program provides a system of no-fault petitioner either:
contain sufficient facts to merit an FDA compensation for certain individuals a. ‘‘[S]ustained, or had significantly
investigation, and must certify that a who have been injured by specified aggravated, any illness, disability,
true and complete copy of the petition childhood vaccines. Subtitle 2 of Title injury, or condition not set forth in the
has been served upon the patent XXI of the PHS Act, 42 U.S.C. 300aa– Vaccine Injury Table but which was
applicant. (See H. Rept. 857, part 1, 98th 10 et seq., provides that those seeking caused by’’ one of the vaccines referred
Cong., 2d sess., pp. 41–42, 1984.) compensation are to file a petition with to in the Table, or
Petitions should be in the format the U.S. Court of Federal Claims and to b. ‘‘[S]ustained, or had significantly
specified in 21 CFR 10.30. serve a copy of the petition on the aggravated, any illness, disability,
Submit petitions electronically to Secretary of HHS, who is named as the injury, or condition set forth in the
https://www.regulations.gov at Docket respondent in each proceeding. The Vaccine Injury Table the first symptom
Nos. FDA–2013–S–0610. Submit written Secretary has delegated this or manifestation of the onset or
petitions (two copies are required) to the responsibility under the program to significant aggravation of which did not
Dockets Management Staff (HFA–305), HRSA. The Court is directed by statute occur within the time period set forth in
Food and Drug Administration, 5630 to appoint special masters who take the Table but which was caused by a
Fishers Lane, Rm. 1061, Rockville, MD evidence, conduct hearings as vaccine’’ referred to in the Table.
20852. appropriate, and make initial decisions In accordance with Section
as to eligibility for, and amount of, 2112(b)(2), all interested persons may
Dated: January 26, 2018.
compensation. submit written information relevant to
Leslie Kux, A petition may be filed with respect the issues described above in the case of
Associate Commissioner for Policy. to injuries, disabilities, illnesses, the petitions listed below. Any person
[FR Doc. 2018–01979 Filed 1–31–18; 8:45 am] conditions, and deaths resulting from choosing to do so should file an original
BILLING CODE 4164–01–P vaccines described in the Vaccine Injury and three (3) copies of the information
Table (the table) set forth at 42 CFR with the Clerk of the U.S. Court of
100.3. This table lists for each covered Federal Claims at the address listed
DEPARTMENT OF HEALTH AND childhood vaccine the conditions that above (under the heading FOR FURTHER
HUMAN SERVICES may lead to compensation and, for each INFORMATION CONTACT), with a copy to
condition, the time period for HRSA addressed to Director, Division of
Health Resources and Services
occurrence of the first symptom or Injury Compensation Programs,
Administration
manifestation of onset or of significant Healthcare Systems Bureau, 5600
aggravation after vaccine Fishers Lane, 08N146B, Rockville, MD
sradovich on DSK3GMQ082PROD with NOTICES

National Vaccine Injury Compensation
Program; List of Petitions Received administration. Compensation may also 20857. The Court’s caption (Petitioner’s
be awarded for conditions not listed in Name v. Secretary of HHS) and the
AGENCY: Health Resources and Services the Table and for conditions that are docket number assigned to the petition
Administration (HRSA), Department of manifested outside the time periods should be used as the caption for the
Health and Human Services (HHS). specified in the table, but only if the written submission. Chapter 35 of title
petitioner shows that the condition was 44, United States Code, related to
ACTION: Notice.
caused by one of the listed vaccines. paperwork reduction, does not apply to

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Document Created: 2018-10-26 13:48:09
Document Modified: 2018-10-26 13:48:09

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 2, 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 July 31, 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 4661

83 FR 4661 - Determination of Regulatory Review Period for Purposes of Patent Extension; CORLANOR

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 22 (February 1, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration