81 FR 34352 - Determination of Regulatory Review Period for Purposes of Patent Extension; OLYSIO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

Page Range		34352-34353
FR Document		2016-12708

The Food and Drug Administration (FDA) has determined the regulatory review period for OLYSIO 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 104 (Tuesday, May 31, 2016)

[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34352-34353]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-12708]

[[Page 34352]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-3441 and FDA-2015-E-3439]

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

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 OLYSIO 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 August
1, 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 November 28, 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-2015-E-3441 or FDA-2015-E-3439 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; OLYSIO.'' 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
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 OLYSIO
(simeprevir). OLYSIO is indicated for

[[Page 34353]]

treatment of chronic hepatitis C infection as a component of a
combination antiviral treatment regimen. Subsequent to this approval,
the USPTO received patent term restoration applications for OLYSIO
(U.S. Patent Nos. 7,671,032 and 8,349,869) from Medivir AB and Janssen
R&D Ireland, and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
October 15, 2015, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
OLYSIO 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
OLYSIO is 2,006 days. Of this time, 1,766 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: May 28, 2008. FDA has verified the Medivir AB and Janssen
R&D Ireland claim that May 28, 2008, 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: March 28,
2013. FDA has verified the applicant's claim that the new drug
application (NDA) for OLYSIO (NDA 205123) was initially submitted on
March 28, 2013.
3. The date the application was approved: November 22, 2013. FDA
has verified the applicant's claim that NDA 205123 was approved on
November 22, 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 applications for patent extension
and amendments, the applicants seek 801 or 280 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.

Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12708 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34353

treatment of chronic hepatitis C (see DATES). Furthermore, any SUPPLEMENTARY INFORMATION: Pursuant
infection as a component of a interested person may petition FDA for to 41 CFR 102–3.65 and approval by the
combination antiviral treatment a determination regarding whether the Department of Health and Human
regimen. Subsequent to this approval, applicant for extension acted with due Services pursuant to 45 CFR part 11 and
the USPTO received patent term diligence during the regulatory review by the General Services Administration,
restoration applications for OLYSIO period. To meet its burden, the petition FDA is announcing the renewal of the
(U.S. Patent Nos. 7,671,032 and must be timely (see DATES) and contain Science Advisory Board to the National
8,349,869) from Medivir AB and Janssen sufficient facts to merit an FDA Center for Toxicological Research. The
R&D Ireland, and the USPTO requested investigation. (See H. Rept. 857, part 1, committee is a discretionary Federal
FDA’s assistance in determining the 98th Cong., 2d sess., pp. 41–42, 1984.) advisory committee established to
patents’ eligibility for patent term Petitions should be in the format provide advice to the Commissioner.
restoration. In a letter dated October 15, specified in 21 CFR 10.30. The Science Advisory Board to the
2015, FDA advised the USPTO that this Submit petitions electronically to National Center for Toxicological
human drug product had undergone a http://www.regulations.gov at Docket Research advises the Commissioner or
regulatory review period and that the No. FDA–2013–S–0610. Submit written designee in discharging responsibilities
approval of OLYSIO represented the petitions (two copies are required) to the as they relate to helping to ensure safe
first permitted commercial marketing or Division of Dockets Management (HFA– and effective drugs for human use and,
use of the product. Thereafter, the 305), Food and Drug Administration, as required, any other product for which
USPTO requested that FDA determine 5630 Fishers Lane, rm. 1061, Rockville, FDA has regulatory responsibility. The
the product’s regulatory review period. MD 20852. Board advises the Director, NCTR, in
II. Determination of Regulatory Review Dated: May 24, 2016. establishing, implementing, and
Period Leslie Kux, evaluation the research programs that
FDA has determined that the Associate Commissioner for Policy. assist the Commissioner of Food and
applicable regulatory review period for [FR Doc. 2016–12708 Filed 5–27–16; 8:45 am] Drugs in fulfilling his regulatory
OLYSIO is 2,006 days. Of this time, BILLING CODE 4164–01–P responsibilities. The Board provides an
1,766 days occurred during the testing extra-agency review in ensuring that the
phase of the regulatory review period, research programs at NCTR are
while 240 days occurred during the DEPARTMENT OF HEALTH AND scientifically sound and pertinent.
approval phase. These periods of time HUMAN SERVICES The Committee shall consist of a core
were derived from the following dates: of nine voting members including the
1. The date an exemption under Food and Drug Administration
Chair. Members and the Chair are
section 505(i) of the Federal Food, Drug, [Docket No. FDA–2016–N–0001] selected by the Commissioner or
and Cosmetic Act (the FD&C Act) (21 designee from among authorities
U.S.C. 355(i)) became effective: May 28, Advisory Committee; Science Advisory knowledgeable in the fields of
2008. FDA has verified the Medivir AB Board to the National Center for
toxicological research. Members will be
and Janssen R&D Ireland claim that May Toxicological Research; Renewal
invited to serve for overlapping terms of
28, 2008, is the date the investigational AGENCY: Food and Drug Administration, up to 4 years. Almost all non-Federal
new drug application (IND) became HHS. members of this committee serve as
effective. Special Government Employees. The
2. The date the application was ACTION:Notice; renewal of advisory
committee. core of voting members may include one
initially submitted with respect to the
technically qualified member, selected
human drug product under section SUMMARY: The Food and Drug
505(b) of the FD&C Act: March 28, 2013. by the Commissioner or designee, who
Administration (FDA) is announcing the is identified with consumer interests
FDA has verified the applicant’s claim renewal of the Science Advisory Board
that the new drug application (NDA) for and is recommended by either a
to the National Center for Toxicological consortium of consumer-oriented
OLYSIO (NDA 205123) was initially Research (NCTR) by the Commissioner
submitted on March 28, 2013. organizations or other interested
of Food and Drugs (the Commissioner). persons.
3. The date the application was The Commissioner has determined that
approved: November 22, 2013. FDA has it is in the public interest to renew the Further information regarding the
verified the applicant’s claim that NDA Science Advisory Board to the National most recent charter and other
205123 was approved on November 22, Center for Toxicological Research for an information can be found at http://
2013. additional 2 years beyond the charter www.fda.gov/AdvisoryCommittees/
This determination of the regulatory CommitteesMeetingMaterials/
expiration date. The new charter will be
review period establishes the maximum ToxicologicalResearch/ucm148166.htm
in effect until June 2, 2018.
potential length of a patent extension. or by contacting the Designated Federal
However, the USPTO applies several DATES: Authority for the Science
Advisory Board to the National Center Officer (see FOR FURTHER INFORMATION
statutory limitations in its calculations CONTACT). In light of the fact that no
of the actual period for patent extension. for Toxicological Research will expire
on June 2, 2016, unless the change has been made to the committee
In its applications for patent extension name or description of duties, no
and amendments, the applicants seek Commissioner formally determines that
renewal is in the public interest. amendment will be made to 21 CFR
sradovich on DSK3TPTVN1PROD with NOTICES

801 or 280 days of patent term 14.100.
extension. FOR FURTHER INFORMATION CONTACT:
Donna L. Mendrick, National Center for This document is issued under the
III. Petitions Toxicological Research, Food and Drug Federal Advisory Committee Act (5
Anyone with knowledge that any of Administration, 10903 New Hampshire U.S.C. app.). For general information
the dates as published are incorrect may Ave., Bldg. 32, Rm. 2208, Silver Spring, related to FDA advisory committees,
submit either electronic or written MD 20993–0002, 301–796–8892, please visit us at http://www.fda.gov/
comments and ask for a redetermination donna.mendrick@fda.hhs.gov. AdvisoryCommittees/default.htm.

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Document Created: 2016-05-28 03:57:12
Document Modified: 2016-05-28 03:57:12

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 August 1, 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 November 28, 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 34352

81 FR 34352 - Determination of Regulatory Review Period for Purposes of Patent Extension; OLYSIO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration