81_FR_87276 81 FR 87044 - Determination of Regulatory Review Period for Purposes of Patent Extension; OPDIVO

81 FR 87044 - Determination of Regulatory Review Period for Purposes of Patent Extension; OPDIVO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 232 (December 2, 2016)

Page Range87044-87045
FR Document2016-28917

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

Federal Register, Volume 81 Issue 232 (Friday, December 2, 2016) 
[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)]
[Notices]
[Pages 87044-87045]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0616]


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

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 OPDIVO 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 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 January 
31, 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 May 31, 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: 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): 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-2016-E-0616 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; OPDIVO.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://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 https://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 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 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

[[Page 87045]]

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 product 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 OPDIVO 
(nivolumab). OPDIVO is indicated for the treatment of patients with 
unresectable or metastatic melanoma and disease progression following 
ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. 
Subsequent to this approval, the USPTO received a patent term 
restoration application for OPDIVO (U.S. Patent No. 8,008,449) from 
E.R. Squibb & Sons, LLC and Ono Pharmaceutical Co., Ltd., and the USPTO 
requested FDA's assistance in determining this patent's 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 OPDIVO 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 
OPDIVO is 3,071 days. Of this time, 2,925 days occurred during the 
testing phase of the regulatory review period, while 146 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: July 28, 
2006. The applicants claim July 29, 2006, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 28, 2006, 
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): July 30, 2014. FDA has verified the 
applicants' claim that the biologics license application (BLA) for 
OPDIVO (BLA 125554) was initially submitted on July 30, 2014.
    3. The date the application was approved: December 22, 2014. FDA 
has verified the applicants' claim that BLA 125554 was approved on 
December 22, 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 the application for patent extension, 
these applicants seek 552 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 https://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: November 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28917 Filed 12-1-16; 8:45 am]
 BILLING CODE 4164-01-P

87044 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices practices regulation (21 CFR 10.115). or written comments and ask for a viewable at https://www.regulations.gov The draft guidance, when finalized, will redetermination by January 31, 2017. or at the Division of Dockets represent the current thinking of FDA Furthermore, any interested person may Management between 9 a.m. and 4 p.m., on the format and content of PBPK petition FDA for a determination Monday through Friday. analyses. It does not establish any rights regarding whether the applicant for • Confidential Submissions—To for any person and is not binding on extension acted with due diligence submit a comment with confidential FDA or the public. You can use an during the regulatory review period by information that you do not wish to be alternative approach if it satisfies the May 31, 2017. See ‘‘Petitions’’ in the made publicly available, submit your requirements of the applicable statutes SUPPLEMENTARY INFORMATION section for comments only as a written/paper and regulations. more information. submission. You should submit two ADDRESSES: You may submit comments copies total. One copy will include the II. Electronic Access as follows: information you claim to be confidential Persons with access to the Internet with a heading or cover note that states may obtain the draft guidance at either Electronic Submissions ‘‘THIS DOCUMENT CONTAINS http://www.fda.gov/Drugs/ Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The GuidanceComplianceRegulatory following way: Agency will review this copy, including Information/Guidances/default.htm or • Federal eRulemaking Portal: the claimed confidential information, in https://www.regulations.gov. https://www.regulations.gov. Follow the its consideration of comments. The instructions for submitting comments. second copy, which will have the III. Paperwork Reduction Act of 1995 Comments submitted electronically, claimed confidential information This draft guidance refers to including attachments, to https:// redacted/blacked out, will be available previously approved collections of www.regulations.gov will be posted to for public viewing and posted on information found in FDA regulations. the docket unchanged. Because your https://www.regulations.gov. Submit These collections of information are comment will be made public, you are both copies to the Division of Dockets subject to review by the Office of solely responsible for ensuring that your Management. If you do not wish your Management and Budget (OMB) under comment does not include any name and contact information to be the Paperwork Reduction Act of 1995 confidential information that you or a made publicly available, you can (44 U.S.C. 3501–3520). The collection of third party may not wish to be posted, provide this information on the cover information in 21 CFR 314.50(d) has such as medical information, your or sheet and not in the body of your been approved under OMB control anyone else’s Social Security number, or comments and you must identify this number 0910–0001. confidential business information, such information as ‘‘confidential.’’ Any Dated: November 29, 2016. as a manufacturing process. Please note information marked as ‘‘confidential’’ that if you include your name, contact will not be disclosed except in Leslie Kux, information, or other information that accordance with 21 CFR 10.20 and other Associate Commissioner for Policy. identifies you in the body of your applicable disclosure law. For more [FR Doc. 2016–28971 Filed 12–1–16; 8:45 am] comments, that information will be information about FDA’s posting of BILLING CODE 4164–01–P posted on https://www.regulations.gov. comments to public dockets, see 80 FR • If you want to submit a comment 56469, September 18, 2015, or access with confidential information that you the information at: http://www.fda.gov/ DEPARTMENT OF HEALTH AND do not wish to be made available to the HUMAN SERVICES regulatoryinformation/dockets/ public, submit the comment as a default.htm. written/paper submission and in the Docket: For access to the docket to Food and Drug Administration manner detailed (see ‘‘Written/Paper read background documents or the [Docket No. FDA–2016–E–0616] Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Written/Paper Submissions received, go to https:// Determination of Regulatory Review www.regulations.gov and insert the Period for Purposes of Patent Submit written/paper submissions as docket number, found in brackets in the Extension; OPDIVO follows: • Mail/Hand delivery/Courier (for heading of this document, into the AGENCY: Food and Drug Administration, written/paper submissions): Division of ‘‘Search’’ box and follow the prompts HHS. Dockets Management (HFA–305), Food and/or go to the Division of Dockets ACTION: Notice. and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. SUMMARY: The Food and Drug • For written/paper comments FOR FURTHER INFORMATION CONTACT: Administration (FDA) has determined submitted to the Division of Dockets Beverly Friedman, Office of Regulatory the regulatory review period for Management, FDA will post your Policy, Food and Drug Administration, OPDIVO and is publishing this notice of comment, as well as any attachments, 10903 New Hampshire Ave., Bldg. 51, that determination as required by law. except for information submitted, Rm. 6250, Silver Spring, MD 20993, FDA has made the determination marked and identified, as confidential, 301–796–3600. because of the submission of an if submitted as detailed in SUPPLEMENTARY INFORMATION: application to the Director of the U.S. ‘‘Instructions.’’ asabaliauskas on DSK3SPTVN1PROD with NOTICES Patent and Trademark Office (USPTO), Instructions: All submissions received I. Background Department of Commerce, for the must include the Docket No. FDA– The Drug Price Competition and extension of a patent which claims that 2016–E–0616 for ‘‘Determination of Patent Term Restoration Act of 1984 human biological product. Regulatory Review Period for Purposes (Pub. L. 98–417) and the Generic DATES: Anyone with knowledge that any of Patent Extension; OPDIVO.’’ Received Animal Drug and Patent Term of the dates as published (see the comments will be placed in the docket Restoration Act (Pub. L. 100–670) SUPPLEMENTARY INFORMATION section) are and, except for those submitted as generally provide that a patent may be incorrect may submit either electronic ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years VerDate Sep<11>2014 17:55 Dec 01, 2016 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1

Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices 87045 so long as the patented item (human approval phase. These periods of time DEPARTMENT OF HEALTH AND drug product, animal drug product, were derived from the following dates: HUMAN SERVICES medical device, food additive, or color 1. The date an exemption under additive) was subject to regulatory section 505(i) of the Federal Food, Drug, Food and Drug Administration review by FDA before the item was and Cosmetic Act (21 U.S.C. 355(i)) [Docket No. FDA–2015–E–5107] marketed. Under these acts, a product’s became effective: July 28, 2006. The regulatory review period forms the basis applicants claim July 29, 2006, as the Determination of Regulatory Review for determining the amount of extension date the investigational new drug Period for Purposes of Patent an applicant may receive. application (IND) became effective. Extension; TRESIBA A regulatory review period consists of However, FDA records indicate that the two periods of time: A testing phase and IND effective date was July 28, 2006, AGENCY: Food and Drug Administration, an approval phase. For human which was the first date after receipt of HHS. biological products, the testing phase the IND that the investigational studies ACTION: Notice. begins when the exemption to permit were allowed to proceed. SUMMARY: The Food and Drug the clinical investigations of the 2. The date the application was Administration (FDA) has determined biological product becomes effective initially submitted with respect to the the regulatory review period for and runs until the approval phase human biological product under section begins. The approval phase starts with TRESIBA and is publishing this notice 351 of the Public Health Service Act (42 the initial submission of an application of that determination as required by U.S.C. 262): July 30, 2014. FDA has to market the human biological product law. FDA has made the determination verified the applicants’ claim that the and continues until FDA grants because of the submission of an biologics license application (BLA) for permission to market the biological application to the Director of the U.S. OPDIVO (BLA 125554) was initially product. Although only a portion of a Patent and Trademark Office (USPTO), submitted on July 30, 2014. regulatory review period may count Department of Commerce, for the 3. The date the application was toward the actual amount of extension extension of a patent which claims that approved: December 22, 2014. FDA has that the Director of USPTO may award human drug product. verified the applicants’ claim that BLA (for example, half the testing phase must 125554 was approved on December 22, DATES: Anyone with knowledge that any be subtracted as well as any time that 2014. of the dates as published (in the may have occurred before the patent This determination of the regulatory SUPPLEMENTARY INFORMATION section) are was issued), FDA’s determination of the review period establishes the maximum incorrect may submit either electronic length of a regulatory review period for potential length of a patent extension. or written comments and ask for a a human biological product will include However, the USPTO applies several redetermination by January 31, 2017 all of the testing phase and approval statutory limitations in its calculations Furthermore, any interested person may phase as specified in 35 U.S.C. of the actual period for patent extension. petition FDA for a determination 156(g)(1)(B). In the application for patent extension, regarding whether the applicant for FDA has approved for marketing the these applicants seek 552 days of patent extension acted with due diligence human biologic product OPDIVO term extension. during the regulatory review period by (nivolumab). OPDIVO is indicated for May 31, 2017. See ‘‘Petitions’’ in the the treatment of patients with III. Petitions SUPPLEMENTARY INFORMATION section for unresectable or metastatic melanoma Anyone with knowledge that any of more information. and disease progression following the dates as published are incorrect may ADDRESSES: You may submit comments ipilimumab and, if BRAF V600 submit either electronic or written as follows: mutation positive, a BRAF inhibitor. comments and ask for a redetermination Subsequent to this approval, the USPTO Electronic Submissions (see DATES). Furthermore, any interested received a patent term restoration person may petition FDA for a Submit electronic comments in the application for OPDIVO (U.S. Patent No. determination regarding whether the following way: 8,008,449) from E.R. Squibb & Sons, applicant for extension acted with due • Federal eRulemaking Portal: http:// LLC and Ono Pharmaceutical Co., Ltd., diligence during the regulatory review www.regulations.gov. Follow the and the USPTO requested FDA’s period. To meet its burden, the petition instructions for submitting comments. assistance in determining this patent’s must be timely (see DATES) and contain Comments submitted electronically, eligibility for patent term restoration. In sufficient facts to merit an FDA including attachments, to http:// a letter dated April 26, 2016, FDA investigation. (See H. Rept. 857, part 1, www.regulations.gov will be posted to advised the USPTO that this human 98th Cong., 2d sess., pp. 41–42, 1984.) the docket unchanged. Because your biological product had undergone a Petitions should be in the format comment will be made public, you are regulatory review period and that the specified in 21 CFR 10.30. solely responsible for ensuring that your approval of OPDIVO represented the Submit petitions electronically to comment does not include any first permitted commercial marketing or https://www.regulations.gov at Docket confidential information that you or a use of the product. Thereafter, the No. FDA–2013–S–0610. Submit written third party may not wish to be posted, USPTO requested that FDA determine petitions (two copies are required) to the such as medical information, your or the product’s regulatory review period. Division of Dockets Management (HFA– anyone else’s Social Security number, or confidential business information, such asabaliauskas on DSK3SPTVN1PROD with NOTICES II. Determination of Regulatory Review 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, as a manufacturing process. Please note Period that if you include your name, contact MD 20852. FDA has determined that the information, or other information that applicable regulatory review period for Dated: November 23, 2016. identifies you in the body of your OPDIVO is 3,071 days. Of this time, Leslie Kux, comments, that information will be 2,925 days occurred during the testing Associate Commissioner for Policy. posted on http://www.regulations.gov. phase of the regulatory review period, [FR Doc. 2016–28917 Filed 12–1–16; 8:45 am] • If you want to submit a comment while 146 days occurred during the BILLING CODE 4164–01–P with confidential information that you VerDate Sep<11>2014 17:55 Dec 01, 2016 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1


Document Created: 2018-02-14 09:01:57
Document Modified: 2018-02-14 09:01:57
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 January 31, 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 May 31, 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 87044 
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