81_FR_47539 81 FR 47399 - Determination of Regulatory Review Period for Purposes of Patent Extension; QUTENZA

81 FR 47399 - Determination of Regulatory Review Period for Purposes of Patent Extension; QUTENZA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 140 (July 21, 2016)

Page Range47399-47400
FR Document2016-17187

The Food and Drug Administration (FDA) has determined the regulatory review period for QUTENZA 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 140 (Thursday, July 21, 2016) 
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47399-47400]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0406]


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

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 QUTENZA 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 
September 19, 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 January 17, 
2017. 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-2010-E-0406 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; QUTENZA.'' 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

[[Page 47400]]

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 QUTENZA 
(capsaicin). QUTENZA is indicated for management of neuropathic pain 
associated with postherpetic neuralgia. Subsequent to this approval, 
the USPTO received a patent term restoration application for QUTENZA 
(U.S. Patent No. 6,239,180) from NeurogesX, Inc., and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration and also requested that FDA determine the 
product's regulatory review period. In a letter dated June 23, 2016, 
FDA advised the USPTO that this human drug product had undergone a 
regulatory review period and that the approval of QUTENZA represented 
the first permitted commercial marketing or use of the product. 
Thereafter, FDA also determined the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
QUTENZA is 2,944 days. Of this time, 2,547 days occurred during the 
testing phase of the regulatory review period, while 397 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: October 27, 2001. The applicant claims September 27, 2001, 
as the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was October 27, 2001, 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 
16, 2008. The applicant claims October 13, 2008, as the date the new 
drug application (NDA) for QUTENZA was initially submitted. However, 
FDA records indicate that NDA 22-395 was submitted on October 16, 2008.
    3. The date the application was approved: November 16, 2009. FDA 
has verified the applicant's claim that NDA 22-395 was approved on 
November 16, 2009.
    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 1,687 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: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17187 Filed 7-20-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 47399 presentation materials at public Description of Respondents: The 60-day notice requesting public meetings. FDA will publish ERG’s respondents to this collection of comment on the proposed extension of assessments, with interview results and information are sponsor representatives this collection of information. No findings, in the Federal Register for for NME NDAs and original BLAs. comments were received. public comment. In the Federal Register of December We estimate the burden of this 10, 2015 (80 FR 76699), we published a collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Total Average Number of Portion of study responses per annual burden Total hours respondents respondent responses per response Pre-test ................................................................................. 5 1 5 1.5 7.50 Interviews ............................................................................. 135 1 135 1.5 202.50 Total .............................................................................. ........................ ........................ ........................ ........................ 210 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA typically reviews approximately application to the Director of the U.S. public, submit the comment as a 40 to 45 NME NDAs and original BLAs Patent and Trademark Office (USPTO), written/paper submission and in the per year. ERG interviews 1 to 3 sponsor Department of Commerce, for the manner detailed (see ‘‘Written/Paper representatives at a time for each extension of a patent which claims that Submissions’’ and ‘‘Instructions’’). application that receives a first-cycle human drug product. Written/Paper Submissions action from FDA, up to 135 sponsor DATES: Anyone with knowledge that any representatives per year. ERG conducts of the dates as published (in the Submit written/paper submissions as a pretest of the interview protocol with follows: SUPPLEMENTARY INFORMATION section) are five respondents. FDA estimates that it • Mail/Hand delivery/Courier (for incorrect may submit either electronic will take 1.0 to 1.5 hours to complete written/paper submissions): Division of or written comments and ask for a Dockets Management (HFA–305), Food the pretest, for a total of a maximum of redetermination by September 19, 2016. 7.5 hours. We estimate that up to 135 and Drug Administration, 5630 Fishers Furthermore, any interested person may Lane, Rm. 1061, Rockville, MD 20852. respondents will take part in the post- petition FDA for a determination action interviews each year, with each • For written/paper comments regarding whether the applicant for submitted to the Division of Dockets interview lasting 1.0 to 1.5 hours, for a extension acted with due diligence Management, FDA will post your total of a maximum of 202.5 hours. during the regulatory review period by comment, as well as any attachments, Thus, the total estimated annual burden January 17, 2017. See ‘‘Petitions’’ in the except for information submitted, is 210 hours. FDA’s burden estimate is SUPPLEMENTARY INFORMATION section for marked and identified, as confidential, based on prior experience with similar more information. if submitted as detailed in interviews with the regulated ADDRESSES: You may submit comments ‘‘Instructions.’’ community. as follows: Instructions: All submissions received Dated: July 14, 2016. must include the Docket No. FDA– Electronic Submissions Leslie Kux, 2010–E–0406 for ‘‘Determination of Associate Commissioner for Policy. Submit electronic comments in the Regulatory Review Period for Purposes [FR Doc. 2016–17185 Filed 7–20–16; 8:45 am] following way: of Patent Extension; QUTENZA.’’ BILLING CODE 4164–01–P • Federal eRulemaking Portal: http:// Received comments will be placed in www.regulations.gov. Follow the the docket and, except for those instructions for submitting comments. submitted as ‘‘Confidential DEPARTMENT OF HEALTH AND Comments submitted electronically, Submissions,’’ publicly viewable at HUMAN SERVICES including attachments, to http:// http://www.regulations.gov or at the www.regulations.gov will be posted to Division of Dockets Management Food and Drug Administration the docket unchanged. Because your between 9 a.m. and 4 p.m., Monday comment will be made public, you are through Friday. [Docket No. FDA–2010–E–0406] solely responsible for ensuring that your • Confidential Submissions—To comment does not include any submit a comment with confidential Determination of Regulatory Review confidential information that you or a information that you do not wish to be Period for Purposes of Patent third party may not wish to be posted, made publicly available, submit your Extension; QUTENZA such as medical information, your or comments only as a written/paper AGENCY: Food and Drug Administration, anyone else’s Social Security number, or submission. You should submit two HHS. confidential business information, such copies total. One copy will include the as a manufacturing process. Please note information you claim to be confidential asabaliauskas on DSK3SPTVN1PROD with NOTICES ACTION: Notice. that if you include your name, contact with a heading or cover note that states SUMMARY: The Food and Drug information, or other information that ‘‘THIS DOCUMENT CONTAINS Administration (FDA) has determined identifies you in the body of your CONFIDENTIAL INFORMATION.’’ The the regulatory review period for comments, that information will be Agency will review this copy, including QUTENZA and is publishing this notice posted on http://www.regulations.gov. the claimed confidential information, in of that determination as required by • If you want to submit a comment its consideration of comments. The law. FDA has made the determination with confidential information that you second copy, which will have the because of the submission of an do not wish to be made available to the claimed confidential information VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1

47400 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices redacted/blacked out, will be available product and continues until FDA grants 3. The date the application was for public viewing and posted on http:// permission to market the drug product. approved: November 16, 2009. FDA has www.regulations.gov. Submit both Although only a portion of a verified the applicant’s claim that NDA copies to the Division of Dockets regulatory review period may count 22–395 was approved on November 16, Management. If you do not wish your toward the actual amount of extension 2009. name and contact information to be that the Director of USPTO may award This determination of the regulatory made publicly available, you can (for example, half the testing phase must review period establishes the maximum provide this information on the cover be subtracted as well as any time that potential length of a patent extension. sheet and not in the body of your may have occurred before the patent However, the USPTO applies several comments and you must identify this was issued), FDA’s determination of the statutory limitations in its calculations information as ‘‘confidential.’’ Any length of a regulatory review period for of the actual period for patent extension. information marked as ‘‘confidential’’ a human drug product will include all In its application for patent extension, will not be disclosed except in of the testing phase and approval phase this applicant seeks 1,687 days of patent accordance with 21 CFR 10.20 and other as specified in 35 U.S.C. 156(g)(1)(B). term extension. applicable disclosure law. For more FDA has approved for marketing the human drug product QUTENZA III. Petitions information about FDA’s posting of comments to public dockets, see 80 FR (capsaicin). QUTENZA is indicated for Anyone with knowledge that any of 56469, September 18, 2015, or access management of neuropathic pain the dates as published are incorrect may the information at: http://www.fda.gov/ associated with postherpetic neuralgia. submit either electronic or written regulatoryinformation/dockets/ Subsequent to this approval, the USPTO comments and ask for a redetermination default.htm. received a patent term restoration (see DATES). Furthermore, any interested application for QUTENZA (U.S. Patent person may petition FDA for a Docket: For access to the docket to No. 6,239,180) from NeurogesX, Inc., determination regarding whether the read background documents or the and the USPTO requested FDA’s electronic and written/paper comments applicant for extension acted with due assistance in determining this patent’s diligence during the regulatory review received, go to http:// eligibility for patent term restoration www.regulations.gov and insert the period. To meet its burden, the petition and also requested that FDA determine must be timely (see DATES) and contain docket number, found in brackets in the the product’s regulatory review period. heading of this document, into the sufficient facts to merit an FDA In a letter dated June 23, 2016, FDA investigation. (See H. Rept. 857, part 1, ‘‘Search’’ box and follow the prompts advised the USPTO that this human and/or go to the Division of Dockets 98th Cong., 2d sess., pp. 41–42, 1984.) drug product had undergone a Petitions should be in the format Management, 5630 Fishers Lane, Rm. regulatory review period and that the 1061, Rockville, MD 20852. specified in 21 CFR 10.30. approval of QUTENZA represented the Submit petitions electronically to FOR FURTHER INFORMATION CONTACT: first permitted commercial marketing or http://www.regulations.gov at Docket Beverly Friedman, Office of Regulatory use of the product. Thereafter, FDA also No. FDA–2013–S–0610. Submit written Policy, Food and Drug Administration, determined the product’s regulatory petitions (two copies are required) to the 10903 New Hampshire Ave., Bldg. 51, review period. Division of Dockets Management (HFA– Rm. 6250, Silver Spring, MD 20993, 305), Food and Drug Administration, II. Determination of Regulatory Review 301–796–3600. 5630 Fishers Lane, Rm. 1061, Rockville, Period SUPPLEMENTARY INFORMATION: MD 20852. FDA has determined that the Dated: July 14, 2016. I. Background applicable regulatory review period for QUTENZA is 2,944 days. Of this time, Leslie Kux, The Drug Price Competition and 2,547 days occurred during the testing Associate Commissioner for Policy. Patent Term Restoration Act of 1984 phase of the regulatory review period, [FR Doc. 2016–17187 Filed 7–20–16; 8:45 am] (Pub. L. 98–417) and the Generic while 397 days occurred during the BILLING CODE 4164–01–P Animal Drug and Patent Term approval phase. These periods of time Restoration Act (Pub. L. 100–670) were derived from the following dates: generally provide that a patent may be 1. The date an exemption under DEPARTMENT OF HEALTH AND extended for a period of up to 5 years section 505(i) of the Federal Food, Drug, HUMAN SERVICES so long as the patented item (human and Cosmetic Act (the FD&C Act) (21 drug product, animal drug product, U.S.C. 355(i)) became effective: October National Institutes of Health medical device, food additive, or color 27, 2001. The applicant claims additive) was subject to regulatory Center for Scientific Review; Notice of September 27, 2001, as the date the review by FDA before the item was Closed Meeting investigational new drug application marketed. Under these acts, a product’s (IND) became effective. However, FDA Pursuant to section 10(d) of the regulatory review period forms the basis records indicate that the IND effective Federal Advisory Committee Act, as for determining the amount of extension date was October 27, 2001, which was amended (5 U.S.C. App.), notice is an applicant may receive. 30 days after FDA receipt of the IND. hereby given of the following meeting. A regulatory review period consists of 2. The date the application was The meeting will be closed to the two periods of time: A testing phase and initially submitted with respect to the public in accordance with the asabaliauskas on DSK3SPTVN1PROD with NOTICES an approval phase. For human drug human drug product under section provisions set forth in sections products, the testing phase begins when 505(b) of the FD&C Act: October 16, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., the exemption to permit the clinical 2008. The applicant claims October 13, as amended. The grant applications and investigations of the drug becomes 2008, as the date the new drug the discussions could disclose effective and runs until the approval application (NDA) for QUTENZA was confidential trade secrets or commercial phase begins. The approval phase starts initially submitted. However, FDA property such as patentable material, with the initial submission of an records indicate that NDA 22–395 was and personal information concerning application to market the human drug submitted on October 16, 2008. individuals associated with the grant VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1


Document Created: 2018-02-08 07:59:00
Document Modified: 2018-02-08 07:59:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone 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 September 19, 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 January 17, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly 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 Citation81 FR 47399 
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