83 FR 6868 - Determination of Regulatory Review Period for Purposes of Patent Extension; ORKAMBI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

Page Range		6868-6869
FR Document		2018-03127

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORKAMBI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 32 (Thursday, February 15, 2018)

[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6868-6869]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-03127]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1301; FDA-2016-E-1302; and FDA-2016-E-1299]

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

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 ORKAMBI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application 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
16, 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 14, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 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-2016-E-1301; FDA-2016-E-1302; and FDA-2016-E-1299 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ORKAMBI.'' 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,

[[Page 6869]]

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 ORKAMBI
(lumacaftor and ivacaftor). ORKAMBI is indicated for the treatment of
cystic fibrosis (CF) in patients age 12 years and older who are
homozygous for the F508del mutation in the CFTR gene. Subsequent to
this approval, the USPTO received patent term restoration applications
for ORKAMBI (U.S. Patent Nos. 8,653,103; 8,741,933; and 8,846,718) from
Vertex Pharmaceuticals Inc., and the USPTO requested FDA's assistance
in determining the patents' eligibility for patent term restoration. In
a letter dated July 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ORKAMBI 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
ORKAMBI is 2,785 days. Of this time, 2,545 days occurred during the
testing phase of the regulatory review period, while 240 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: November 18, 2007. FDA has verified the applicant's claim
that November 18, 2007, is the date the investigational new drug
application (IND) became effective.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
5, 2014. FDA has verified the applicant's claim that the new drug
application (NDA) for ORKAMBI (NDA 206038) was initially submitted on
November 5, 2014.
3. The date the application was approved: July 2, 2015. FDA has
verified the applicant's claim that NDA 206038 was approved on July 2,
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 210 or 317 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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03127 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6869

10903 New Hampshire Ave. Bldg. 51, USPTO requested that FDA determine Submit petitions electronically to
Rm. 6250, Silver Spring, MD 20993, the product’s regulatory review period. https://www.regulations.gov at Docket
301–796–3600. No. FDA–2013–S–0610. Submit written
II. Determination of Regulatory Review
SUPPLEMENTARY INFORMATION: petitions (two copies are required) to the
Period
Dockets Management Staff (HFA–305),
I. Background FDA has determined that the Food and Drug Administration, 5630
The Drug Price Competition and applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD
Patent Term Restoration Act of 1984 ORKAMBI is 2,785 days. Of this time, 20852.
(Pub. L. 98–417) and the Generic 2,545 days occurred during the testing
Dated: February 9, 2018.
Animal Drug and Patent Term phase of the regulatory review period,
while 240 days occurred during the Leslie Kux,
Restoration Act (Pub. L. 100–670) Associate Commissioner for Policy.
generally provide that a patent may be approval phase. These periods of time
extended for a period of up to 5 years were derived from the following dates: [FR Doc. 2018–03127 Filed 2–14–18; 8:45 am]
1. The date an exemption under BILLING CODE 4164–01–P
so long as the patented item (human
section 505(i) of the Federal Food, Drug,
drug product, animal drug product,
and Cosmetic Act (the FD&C Act) (21
medical device, food additive, or color DEPARTMENT OF HEALTH AND
U.S.C. 355(i)) became effective:
additive) was subject to regulatory HUMAN SERVICES
November 18, 2007. FDA has verified
review by FDA before the item was
the applicant’s claim that November 18,
marketed. Under these acts, a product’s National Institutes of Health
2007, is the date the investigational new
regulatory review period forms the basis
drug application (IND) became effective.
for determining the amount of extension 2. The date the application was National Institute of Environmental
an applicant may receive. initially submitted with respect to the Health Sciences; Notice of Closed
A regulatory review period consists of human drug product under section Meetings
two periods of time: A testing phase and 505(b) of the FD&C Act: November 5, Pursuant to section 10(d) of the
an approval phase. For human drug 2014. FDA has verified the applicant’s Federal Advisory Committee Act, as
products, the testing phase begins when claim that the new drug application amended, notice is hereby given of the
the exemption to permit the clinical (NDA) for ORKAMBI (NDA 206038) was following meetings.
investigations of the drug becomes initially submitted on November 5, The meetings will be closed to the
effective and runs until the approval 2014. public in accordance with the
phase begins. The approval phase starts 3. The date the application was provisions set forth in sections
with the initial submission of an approved: July 2, 2015. FDA has verified 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
application to market the human drug the applicant’s claim that NDA 206038 as amended. The grant applications and
product and continues until FDA grants was approved on July 2, 2015. the discussions could disclose
permission to market the drug product. This determination of the regulatory confidential trade secrets or commercial
Although only a portion of a regulatory review period establishes the maximum property such as patentable material,
review period may count toward the potential length of a patent extension. and personal information concerning
actual amount of extension that the However, the USPTO applies several individuals associated with the grant
Director of USPTO may award (for statutory limitations in its calculations applications, the disclosure of which
example, half the testing phase must be of the actual period for patent extension. would constitute a clearly unwarranted
subtracted as well as any time that may In its applications for patent extension, invasion of personal privacy.
have occurred before the patent was this applicant seeks 210 or 317 days of
issued), FDA’s determination of the Name of Committee: National Institute of
patent term extension. Environmental Health Sciences Special
length of a regulatory review period for
III. Petitions Emphasis Panel; K99/R00 Career
a human drug product will include all Development in Environmental Research.
of the testing phase and approval phase Anyone with knowledge that any of Date: March 1, 2018.
as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may Time: 8:00 a.m. to 5:00 p.m.
FDA has approved for marketing the submit either electronic or written Agenda: To review and evaluate grant
human drug product ORKAMBI comments and, under 21 CFR 60.24, ask applications.
(lumacaftor and ivacaftor). ORKAMBI is for a redetermination (see DATES). Place: National Institute of Environmental
indicated for the treatment of cystic Furthermore, as specified in § 60.30 (21 Health Sciences, Keystone Building, 530
fibrosis (CF) in patients age 12 years and CFR 60.30), any interested person may Davis Drive, Research Triangle Park, NC
older who are homozygous for the petition FDA for a determination 27709 (Virtual Meeting).
Contact Person: Laura A. Thomas, Ph.D.,
F508del mutation in the CFTR gene. regarding whether the applicant for Scientific Review Officer, Scientific Review
Subsequent to this approval, the USPTO extension acted with due diligence Branch, Division of Extramural Research and
received patent term restoration during the regulatory review period. To Training, National Institute of Environmental
applications for ORKAMBI (U.S. Patent meet its burden, the petition must Health Sciences, Research Triangle Park, NC
Nos. 8,653,103; 8,741,933; and comply with all the requirements of 27709 919–541–2824, laura.thomas@nih.gov.
8,846,718) from Vertex Pharmaceuticals § 60.30, including but not limited to: Name of Committee: National Institute of
Inc., and the USPTO requested FDA’s Must be timely (see DATES), must be Environmental Health Sciences Special
assistance in determining the patents’ filed in accordance with § 10.20, must Emphasis Panel; Evaluation of U01 Grant
eligibility for patent term restoration. In contain sufficient facts to merit an FDA Applications: DNA Repair Capacity (DRC)
sradovich on DSK3GMQ082PROD with NOTICES

a letter dated July 12, 2016, FDA investigation, and must certify that a Assay Measures in Population-Based Studies.
advised the USPTO that this human true and complete copy of the petition Date: March 6, 2018.
Time: 8:30 a.m. to 3:00 p.m.
drug product had undergone a has been served upon the patent Agenda: To review and evaluate grant
regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th applications.
approval of ORKAMBI represented the Cong., 2d sess., pp. 41–42, 1984.) Place: Fairfield Inn & Suites Durham
first permitted commercial marketing or Petitions should be in the format Southpoint, 7807 Leonardo Drive, Durham,
use of the product. Thereafter, the specified in 21 CFR 10.30. NC 27713.

VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1

Document Created: 2018-02-15 00:21:13
Document Modified: 2018-02-15 00:21:13

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 16, 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 14, 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 6868

83 FR 6868 - Determination of Regulatory Review Period for Purposes of Patent Extension; ORKAMBI

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration