81 FR 12741 - Determination of Regulatory Review Period for Purposes of Patent Extension; OPSUMIT

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 47 (March 10, 2016)

Page Range		12741-12742
FR Document		2016-05389

The Food and Drug Administration (FDA) has determined the regulatory review period for OPSUMIT 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 81 Issue 47 (Thursday, March 10, 2016)

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12741-12742]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-05389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2349]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for OPSUMIT 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 May 9,
2016. 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 September 6, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 No.
FDA-2014-E-2349 ``For Determination of Regulatory Review Period for
Purposes of Patent Extension; OPSUMIT.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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

[[Page 12742]]

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 OPSUMIT
(macitentan). OPSUMIT is indicated for the treatment of pulmonary
arterial hypertension to delay disease progression. Subsequent to this
approval, the USPTO received a patent term restoration application for
OPSUMIT (U.S. Patent No. 7,094,781) from Actelion Pharmaceuticals Ltd.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated May 11,
2015, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of OPSUMIT 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
OPSUMIT is 1,935 days. Of this time, 1,570 days occurred during the
testing phase of the regulatory review period, while 365 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: July 3, 2008. The applicant claims July 2, 2008, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was July 3,
2008, which was 30 days after FDA receipt of the 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: October
19, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for OPSUMIT (NDA 204410) was initially submitted on
October 19, 2012.
3. The date the application was approved: October 18, 2013. FDA has
verified the applicant's claim that NDA 204410 was approved on October
18, 2013.
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 application for patent extension,
this applicant seeks 1,151 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 ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (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 http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05389 Filed 3-9-16; 8:45 am]
BILLING CODE 4164-01-P

12742 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices

Restoration Act (Pub. L. 100–670) 1. The date an exemption under Dated: March 7, 2016.
generally provide that a patent may be section 505(i) of the Federal Food, Drug, Leslie Kux,
extended for a period of up to 5 years and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
so long as the patented item (human U.S.C. 355(i)) became effective: July 3, [FR Doc. 2016–05389 Filed 3–9–16; 8:45 am]
drug product, animal drug product, 2008. The applicant claims July 2, 2008, BILLING CODE 4164–01–P
medical device, food additive, or color as the date the investigational new drug
additive) was subject to regulatory application (IND) became effective.
review by FDA before the item was However, FDA records indicate that the DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s IND effective date was July 3, 2008, HUMAN SERVICES
regulatory review period forms the basis
which was 30 days after FDA receipt of
for determining the amount of extension National Institutes of Health
the IND.
an applicant may receive.
A regulatory review period consists of 2. The date the application was National Institute of Neurological
two periods of time: A testing phase and initially submitted with respect to the Disorders and Stroke; Notice of
an approval phase. For human drug human drug product under section Meetings
products, the testing phase begins when 505(b) of the FD&C Act: October 19,
the exemption to permit the clinical Pursuant to section 10(d) of the
2012. FDA has verified the applicant’s
investigations of the drug becomes Federal Advisory Committee Act, as
claim that the new drug application
effective and runs until the approval amended (5 U.S.C. App.), notice is
(NDA) for OPSUMIT (NDA 204410) was hereby given of a meeting of the
phase begins. The approval phase starts initially submitted on October 19, 2012.
with the initial submission of an National Advisory Neurological
application to market the human drug 3. The date the application was Disorders and Stroke Council.
product and continues until FDA grants approved: October 18, 2013. FDA has The meeting will be open to the
permission to market the drug product. verified the applicant’s claim that NDA public as indicated below, with
Although only a portion of a regulatory 204410 was approved on October 18, attendance limited to space available.
review period may count toward the 2013. Individuals who plan to attend and
actual amount of extension that the This determination of the regulatory need special assistance, such as sign
Director of USPTO may award (for review period establishes the maximum language interpretation or other
example, half the testing phase must be potential length of a patent extension. reasonable accommodations, should
subtracted as well as any time that may notify the Contact Person listed below
However, the USPTO applies several
have occurred before the patent was in advance of the meeting.
statutory limitations in its calculations
issued), FDA’s determination of the The meeting will be closed to the
of the actual period for patent extension.
length of a regulatory review period for public in accordance with the
In its application for patent extension,
a human drug product will include all provisions set forth in sections
this applicant seeks 1,151 days of patent 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
of the testing phase and approval phase
term extension. as amended. The grant applications and
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the III. Petitions the discussions could disclose
human drug product OPSUMIT confidential trade secrets or commercial
(macitentan). OPSUMIT is indicated for Anyone with knowledge that any of property such as patentable materials,
the treatment of pulmonary arterial the dates as published are incorrect may and personal information concerning
hypertension to delay disease submit either electronic or written individuals associated with the grant
progression. Subsequent to this comments and ask for a redetermination applications, the disclosure of which
approval, the USPTO received a patent (see DATES). Furthermore, any interested would constitute a clearly unwarranted
term restoration application for person may petition FDA for a invasion of personal privacy.
OPSUMIT (U.S. Patent No. 7,094,781) determination regarding whether the Name of Committee: National Advisory
from Actelion Pharmaceuticals Ltd., and applicant for extension acted with due Neurological Disorders and Stroke Council.
the USPTO requested FDA’s assistance diligence during the regulatory review Date: May 26–27, 2016.
in determining this patent’s eligibility period. To meet its burden, the petition Open: May 26, 2016, 8:00 a.m. to 2:30 p.m.
for patent term restoration. In a letter must be timely (see DATES) and contain Agenda: Report by the Director, NINDS;
dated May 11, 2015, FDA advised the Report by the Associate Director for
sufficient facts to merit an FDA Extramural Research; Administrative and
USPTO that this human drug product
investigation. (See H. Rept. 857, part 1, Program Developments; and an Overview of
had undergone a regulatory review
98th Cong., 2d sess., pp. 41–42, 1984.) the NINDS Intramural Program.
period and that the approval of
Petitions should be in the format Place: National Institutes of Health,
OPSUMIT represented the first Building 31, 31 Center Drive, 6th Floor,
permitted commercial marketing or use specified in 21 CFR 10.30.
Conference Room 10, Bethesda, MD 20892.
of the product. Thereafter, the USPTO Submit petitions electronically to Closed: May 26, 2016, 2:30 p.m. to 4:45
requested that FDA determine the http://www.regulations.gov at Docket p.m.
product’s regulatory review period. No. FDA–2013–S–0610. Submit written Agenda: To review and evaluate grant
petitions (two copies are required) to the applications.
II. Determination of Regulatory Review Place: National Institutes of Health,
Period Division of Dockets Management (HFA–
Building 31, 31 Center Drive, 6th Floor,
305), Food and Drug Administration,
Conference Room 10, Bethesda, MD 20892.
mstockstill on DSK4VPTVN1PROD with NOTICES

FDA has determined that the 5630 Fishers Lane, Rm. 1061, Rockville,
applicable regulatory review period for Closed: May 26, 2016, 4:45 p.m. to 5:15
MD 20852. Petitions that have not been p.m.
OPSUMIT is 1,935 days. Of this time,
made publicly available on http:// Agenda: To review and evaluate the
1,570 days occurred during the testing Division of Intramural Research Board of
www.regulations.gov may be viewed in
phase of the regulatory review period, Scientific Counselors’ Reports.
the Division of Dockets Management
while 365 days occurred during the Place: National Institutes of Health,
approval phase. These periods of time between 9 a.m. and 4 p.m., Monday
Building 31, 31 Center Drive, 6th Floor,
were derived from the following dates: through Friday. Conference Room 10, Bethesda, MD 20892.

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Document Created: 2018-02-02 15:12:14
Document Modified: 2018-02-02 15:12:14

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 May 9, 2016. 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 September 6, 2016. 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		81 FR 12741

81 FR 12741 - Determination of Regulatory Review Period for Purposes of Patent Extension; OPSUMIT

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 47 (March 10, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration