81_FR_88480 81 FR 88245 - Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9

81 FR 88245 - Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 235 (December 7, 2016)

Page Range88245-88246
FR Document2016-29303

The Food and Drug Administration (FDA) has determined the regulatory review period for GARDASIL 9 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 biological product.

Federal Register, Volume 81 Issue 235 (Wednesday, December 7, 2016) 
[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Pages 88245-88246]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29303]



[[Page 88245]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA 2016-E-0630 and FDA-2016-E-1102]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; GARDASIL 9

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 GARDASIL 9 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 
biological product.

DATES: Anyone with knowledge that any of the dates as published (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
February 6, 2017. 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 June 5, 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 Nos. 
FDA 2016-E-0630 and FDA-2016-E-1102 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; GARDASIL 9.'' 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 
biological 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 biologic product GARDASIL 
9

[[Page 88246]]

(Human papillomavirus 9-valent Vaccine, Recombinant). GARDASIL 9 is 
indicated in girls and women 9 through 26 years of age for the 
prevention of the following diseases:
     Cervical, vulvar, vaginal, and anal cancer caused by Human 
Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
     Genital warts caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV 
types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

     Cervical intraepithelial neoplasia (CIN) grade 2/3 and 
cervical adenocarcinoma in situ.
     CIN grade 1.
     Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 
3.
     Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 
1.
     Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.

Gardasil 9 is also indicated in boys and men 9 through 26 years for the 
prevention of the following diseases;

     Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 
58.
     Genital warts caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV 
types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

     AIN grades 1, 2, and 3.
    Subsequent to this approval, the USPTO received patent term 
restoration applications for GARDASIL 9 (U.S. Patent Nos. 7,476,389 and 
7,482,015) from Merck Sharp & Dohme Corp. for CSL Limited and The 
University of Queensland; the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated April 26, 2016, FDA advised the USPTO that this human 
biological product had undergone a regulatory review period and that 
the approval of GARDASIL 9 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 
GARDASIL 9 is 2,662 days. Of this time, 2,296 days occurred during the 
testing phase of the regulatory review period, while 366 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 (21 U.S.C. 355(i)) became effective: August 29, 
2007. The applicant claims September 2, 2007, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 29, 2007, 
which was the first date after receipt of the IND that the 
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): December 10, 2013. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
GARDASIL 9 (BLA 125508/0) was initially submitted on December 10, 2013.
    3. The date the application was approved: December 10, 2014. FDA 
has verified the applicant's claim that BLA 125508/0 was approved on 
December 10, 2014.
    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 1,062 days or 1,254 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 Nos. 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: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29303 Filed 12-6-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices 88245 DEPARTMENT OF HEALTH AND • If you want to submit a comment comments to public dockets, see 80 FR HUMAN SERVICES with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ Food and Drug Administration public, submit the comment as a regulatoryinformation/dockets/ [Docket Nos. FDA 2016–E–0630 and FDA– written/paper submission and in the default.htm. 2016–E–1102] manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). read background documents or the Determination of Regulatory Review electronic and written/paper comments Written/Paper Submissions received, go to http:// Period for Purposes of Patent Extension; GARDASIL 9 Submit written/paper submissions as www.regulations.gov and insert the follows: docket number, found in brackets in the AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for heading of this document, into the HHS. written/paper submissions): Division of ‘‘Search’’ box and follow the prompts ACTION: Notice. Dockets Management (HFA–305), Food and/or go to the Division of Dockets and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. Administration (FDA) has determined • For written/paper comments the regulatory review period for FOR FURTHER INFORMATION CONTACT: submitted to the Division of Dockets Beverly Friedman, Office of Regulatory GARDASIL 9 and is publishing this Management, FDA will post your notice of that determination as required Policy, Food and Drug Administration, comment, as well as any attachments, 10903 New Hampshire Ave., Bldg. 51, by law. FDA has made the except for information submitted, determination because of the Rm. 6250, Silver Spring, MD 20993, marked and identified, as confidential, 301–796–3600. submission of applications to the if submitted as detailed in Director of the U.S. Patent and SUPPLEMENTARY INFORMATION: ‘‘Instructions.’’ Trademark Office (USPTO), Department Instructions: All submissions received I. Background of Commerce, for the extension of a must include the Docket Nos. FDA The Drug Price Competition and patent which claims that human 2016–E–0630 and FDA–2016–E–1102 Patent Term Restoration Act of 1984 biological product. for ‘‘Determination of Regulatory (Pub. L. 98–417) and the Generic DATES: Anyone with knowledge that any Review Period for Purposes of Patent Animal Drug and Patent Term of the dates as published (see the Extension; GARDASIL 9.’’ Received Restoration Act (Pub. L. 100–670) SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket generally provide that a patent may be incorrect may submit either electronic and, except for those submitted as extended for a period of up to 5 years or written comments and ask for a ‘‘Confidential Submissions,’’ publicly so long as the patented item (human redetermination by February 6, 2017. viewable at http://www.regulations.gov drug product, animal drug product, Furthermore, any interested person may or at the Division of Dockets medical device, food additive, or color petition FDA for a determination Management between 9 a.m. and 4 p.m., additive) was subject to regulatory regarding whether the applicant for Monday through Friday. review by FDA before the item was extension acted with due diligence • Confidential Submissions—To marketed. Under these acts, a product’s during the regulatory review period by submit a comment with confidential regulatory review period forms the basis June 5, 2017. See ‘‘Petitions’’ in the information that you do not wish to be for determining the amount of extension SUPPLEMENTARY INFORMATION section for made publicly available, submit your an applicant may receive. more information. comments only as a written/paper A regulatory review period consists of ADDRESSES: You may submit comments submission. You should submit two two periods of time: A testing phase and as follows: copies total. One copy will include the an approval phase. For human information you claim to be confidential biological products, the testing phase Electronic Submissions with a heading or cover note that states begins when the exemption to permit Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the clinical investigations of the following way: CONFIDENTIAL INFORMATION.’’ The biological becomes effective and runs • Federal eRulemaking Portal: http:// Agency will review this copy, including until the approval phase begins. The www.regulations.gov. Follow the the claimed confidential information, in approval phase starts with the initial instructions for submitting comments. its consideration of comments. The submission of an application to market Comments submitted electronically, second copy, which will have the the human biological product and including attachments, to http:// claimed confidential information continues until FDA grants permission www.regulations.gov will be posted to redacted/blacked out, will be available to market the biological product. the docket unchanged. Because your for public viewing and posted on http:// Although only a portion of a regulatory comment will be made public, you are www.regulations.gov. Submit both review period may count toward the solely responsible for ensuring that your copies to the Division of Dockets actual amount of extension that the comment does not include any Management. If you do not wish your Director of USPTO may award (for confidential information that you or a name and contact information to be example, half the testing phase must be third party may not wish to be posted, made publicly available, you can subtracted as well as any time that may such as medical information, your or provide this information on the cover asabaliauskas on DSK3SPTVN1PROD with NOTICES have occurred before the patent was anyone else’s Social Security number, or sheet and not in the body of your issued), FDA’s determination of the confidential business information, such comments and you must identify this length of a regulatory review period for as a manufacturing process. Please note information as ‘‘confidential.’’ Any a human biological product will include that if you include your name, contact information marked as ‘‘confidential’’ all of the testing phase and approval information, or other information that will not be disclosed except in phase as specified in 35 U.S.C. identifies you in the body of your accordance with 21 CFR 10.20 and other 156(g)(1)(B). comments, that information will be applicable disclosure law. For more FDA has approved for marketing the posted on http://www.regulations.gov. information about FDA’s posting of human biologic product GARDASIL 9 VerDate Sep<11>2014 17:54 Dec 06, 2016 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\07DEN1.SGM 07DEN1

88246 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices (Human papillomavirus 9-valent became effective: August 29, 2007. The DEPARTMENT OF HEALTH AND Vaccine, Recombinant). GARDASIL 9 is applicant claims September 2, 2007, as HUMAN SERVICES indicated in girls and women 9 through the date the investigational new drug 26 years of age for the prevention of the application (IND) became effective. Office of the Secretary following diseases: However, FDA records indicate that the [Document Identifier: HHS–OS–0937–0191– • Cervical, vulvar, vaginal, and anal IND effective date was August 29, 2007, 30D] cancer caused by Human which was the first date after receipt of Papillomavirus (HPV) types 16, 18, 31, the IND that the investigational studies Agency Information Collection 33, 45, 52, and 58. were allowed to proceed. Activities; Submission to OMB for • Genital warts caused by HPV types Review and Approval; Public Comment 6 and 11. 2. The date the application was Request And the following precancerous or initially submitted with respect to the dysplastic lesions caused by HPV types human biological product under section AGENCY: Office of the Secretary, HHS. 6, 11, 16, 18, 31, 33, 45, 52, and 58: 351 of the Public Health Service Act (42 ACTION: Notice. • Cervical intraepithelial neoplasia U.S.C. 262): December 10, 2013. FDA has verified the applicant’s claim that SUMMARY: In compliance with section (CIN) grade 2/3 and cervical 3507(a)(1)(D) of the Paperwork adenocarcinoma in situ. the biologics license application (BLA) for GARDASIL 9 (BLA 125508/0) was Reduction Act of 1995, the Office of the • CIN grade 1. Secretary (OS), Department of Health • Vulvar intraepithelial neoplasia initially submitted on December 10, 2013. and Human Services, has submitted an (VIN) grade 2 and grade 3. Information Collection Request (ICR), • Vaginal intraepithelial neoplasia 3. The date the application was described below, to the Office of (VaIN) grade 2 and grade 1. approved: December 10, 2014. FDA has • Anal intraepithelial neoplasia (AIN) Management and Budget (OMB) for verified the applicant’s claim that BLA review and approval. The ICR is for grades 1, 2, and 3. 125508/0 was approved on December renewal of the approved information Gardasil 9 is also indicated in boys and 10, 2014. collection assigned OMB control men 9 through 26 years for the This determination of the regulatory number 0937–0191, scheduled to expire prevention of the following diseases; review period establishes the maximum on December 31, 2016. Comments • Anal cancer caused by HPV types submitted during the first public review potential length of a patent extension. 16, 18, 31, 33, 45, 52 and 58. of this ICR will be provided to OMB. • Genital warts caused by HPV types However, the USPTO applies several statutory limitations in its calculations OMB will accept further comments from 6 and 11. the public on this ICR during the review of the actual period for patent extension. And the following precancerous or and approval period. In its applications for patent extension, dysplastic lesions caused by HPV types DATES: Comments on the ICR must be 6, 11, 16, 18, 31, 33, 45, 52, and 58: this applicant seeks 1,062 days or 1,254 days of patent term extension. received on or before January 6, 2017. • AIN grades 1, 2, and 3. ADDRESSES: Submit your comments to Subsequent to this approval, the III. Petitions OIRA_submission@omb.eop.gov or via USPTO received patent term restoration Anyone with knowledge that any of facsimile to (202) 395–5806. applications for GARDASIL 9 (U.S. Patent Nos. 7,476,389 and 7,482,015) the dates as published are incorrect may FOR FURTHER INFORMATION CONTACT: from Merck Sharp & Dohme Corp. for submit either electronic or written Information Collection Clearance staff, CSL Limited and The University of comments and ask for a redetermination Information.CollectionClearance@ Queensland; the USPTO requested (see DATES). Furthermore, any hhs.gov or (202) 690–5683. FDA’s assistance in determining the interested person may petition FDA for SUPPLEMENTARY INFORMATION: When patents’ eligibility for patent term a determination regarding whether the submitting comments or requesting restoration. In a letter dated April 26, applicant for extension acted with due information, please include the OMB 2016, FDA advised the USPTO that this diligence during the regulatory review control number 0937–0191–30D for human biological product had period. To meet its burden, the petition reference. undergone a regulatory review period must be timely (see DATES) and contain Information Collection Request Title: and that the approval of GARDASIL 9 sufficient facts to merit an FDA Application packets for Real Property represented the first permitted investigation. (See H. Rept. 857, part 1, for Public Health Purposes. commercial marketing or use of the 98th Cong., 2d sess., pp. 41–42, 1984.) OMB No.: 0937–0191. product. Thereafter, the USPTO Petitions should be in the format Abstract: The Office of Assistant requested that FDA determine the specified in 21 CFR 10.30. Secretary for Administration, Program product’s regulatory review period. Support Center, Federal Property Submit petitions electronically to Assistance Program is requesting OMB’s II. Determination of Regulatory Review http://www.regulations.gov at Docket approval on a previously approved Period Nos. FDA–2013–S–0610. Submit written information collection, 0937–0191. The FDA has determined that the petitions (two copies are required) to the Federal Property and Administrative applicable regulatory review period for Division of Dockets Management (HFA– Services Act of 1949 (P.L. 81–152), as GARDASIL 9 is 2,662 days. Of this time, 305), Food and Drug Administration, amended, provides authority to the asabaliauskas on DSK3SPTVN1PROD with NOTICES 2,296 days occurred during the testing 5630 Fishers Lane, Rm. 1061, Rockville, Secretary of Health and Human Services phase of the regulatory review period, MD 20852. to convey or lease surplus real property while 366 days occurred during the Dated: December 1, 2016. to States and their political subdivisions approval phase. These periods of time and instrumentalities, to tax-supported Leslie Kux, were derived from the following dates: institutions, and to nonprofit 1. The date an exemption under Associate Commissioner for Policy. institutions which (except for section 505(i) of the Federal Food, Drug, [FR Doc. 2016–29303 Filed 12–6–16; 8:45 am] institutions which lease property to and Cosmetic Act (21 U.S.C. 355(i)) BILLING CODE 4164–01–P assist the homeless) have been held VerDate Sep<11>2014 17:54 Dec 06, 2016 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\07DEN1.SGM 07DEN1


Document Created: 2016-12-07 05:32:03
Document Modified: 2016-12-07 05:32:03
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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 6, 2017. 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 June 5, 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 88245 
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