81_FR_90185 81 FR 89946 - Determination of Regulatory Review Period for Purposes of Patent Extension; NUCALA

81 FR 89946 - Determination of Regulatory Review Period for Purposes of Patent Extension; NUCALA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 239 (December 13, 2016)

Page Range89946-89947
FR Document2016-29838

The Food and Drug Administration (FDA) has determined the regulatory review period for NUCALA 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 239 (Tuesday, December 13, 2016) 
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89946-89947]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0625]


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

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 NUCALA 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 
February 13, 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 12, 
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-0625 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; NUCALA.'' 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

[[Page 89947]]

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 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 the 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 NUCALA 
(mepolizumab). NUCALA is indicated for add-on maintenance treatment of 
patients with severe asthma aged 12 years and older, and with an 
eosinophilic phenotype. Subsequent to this approval, the USPTO received 
a patent term restoration application for NUCALA (U.S. Patent No. 
5,693,323) from GlaxoSmithKline LLC, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated May 10, 2016, FDA advised the USPTO that 
this human biological product had undergone a regulatory review period 
and that the approval of NUCALA 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 
NUCALA is 6,862 days. Of this time, 6,496 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: January 22, 
1997. The applicant claims January 21, 1997, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was January 22, 1997, 
which was 30 days after FDA receipt of the IND.
    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): November 4, 2014. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
NUCALA (BLA 125526) was initially submitted on November 4, 2014.
    3. The date the application was approved: November 4, 2015. FDA has 
verified the applicant's claim that BLA 125526 was approved on November 
4, 2015.
    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 5 years 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: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29838 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P

89946 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices EARLY TERMINATIONS GRANTED NOVEMBER 1, 2016 THRU NOVEMBER 30, 2016—Continued 20170269 G Kendall Automotive Group, Inc.; David and Lorraine Edmark; Kendall Automotive Group, Inc. 20170271 G Ascent Holdings, LLC; Fulcrum BioEnergy, Inc.; Ascent Holdings, LLC. 20170272 G JBG SMITH Properties; JBG/Operating Partners, L.P.; JBG SMITH Properties. 20170280 G Blue Star Parent, L.P.; Ansira Holdings, LLC; Blue Star Parent, L.P. 20170289 G Antelope NewCo, Inc.; AlixPartners Holdings, LLP; Antelope NewCo, Inc. 11/30/2016 20170159 G The Hearst Family Trust; GTCR Fund X/A LP; The Hearst Family Trust. 20170169 G Insight MB Parent LLC; MB Parent Holdings, LLC; Insight MB Parent LLC. 20170274 G Quintiles IMS Holdings, Inc.; Jon C. Anderson; Quintiles IMS Holdings, Inc. 20170279 G Calpine Corporation; NAPGS Holdco, LLC; Calpine Corporation. 20170281 G Adobe Systems Incorporated; TubeMogul, Inc.; Adobe Systems Incorporated. 20170284 G CENTRO ARTE SCIENZA E TECNOLOGIA S.R.L.; Nestle S. A.; CENTRO ARTE SCIENZA E TECNOLOGIA S.R.L. 20170296 G Bain Capital Fund XI, L.P.; Blue Nile, Inc.; Bain Capital Fund XI, L.P. 20170298 G AIPCF VI AIV Moly-Cop (Cayman), LP; Arrium Limited; AIPCF VI AIV Moly-Cop (Cayman), LP. 20170300 G Wind Point Partners, VIII-A, L.P.; Michael J. Baab; Wind Point Partners, VIII-A, L.P. 20170306 G AIM Marina Holdings, LLC; John D. Brewer, Jr. and Margaret S. Brewer; AIM Marina Holdings, LLC. FOR FURTHER INFORMATION CONTACT: extension acted with due diligence • For written/paper comments Theresa Kingsberry Program Support during the regulatory review period by submitted to the Division of Dockets Specialist, Federal Trade Commission June 12, 2017. See ‘‘Petitions’’ in the Management, FDA will post your Premerger Notification Office Bureau of SUPPLEMENTARY INFORMATION section for comment, as well as any attachments, Competition, Room CC–5301, more information. except for information submitted, Washington, DC 20024, (202) 326–3100. ADDRESSES: You may submit comments marked and identified, as confidential, By direction of the Commission. as follows: if submitted as detailed in Donald S. Clark ‘‘Instructions.’’ Electronic Submissions Instructions: All submissions received Secretary. Submit electronic comments in the must include the Docket No. FDA– [FR Doc. 2016–29771 Filed 12–12–16; 8:45 am] following way: 2016–E–0625 for ‘‘Determination of BILLING CODE 6750–01–P • Federal eRulemaking Portal: Regulatory Review Period for Purposes https://www.regulations.gov. Follow the of Patent Extension; NUCALA.’’ instructions for submitting comments. Received comments will be placed in DEPARTMENT OF HEALTH AND the docket and, except for those Comments submitted electronically, HUMAN SERVICES submitted as ‘‘Confidential including attachments, to https:// Food and Drug Administration www.regulations.gov will be posted to Submissions,’’ publicly viewable at the docket unchanged. Because your https://www.regulations.gov or at the [Docket No. FDA–2016–E–0625] comment will be made public, you are Division of Dockets Management solely responsible for ensuring that your between 9 a.m. and 4 p.m., Monday Determination of Regulatory Review through Friday. comment does not include any Period for Purposes of Patent • Confidential Submissions—To confidential information that you or a Extension; NUCALA submit a comment with confidential third party may not wish to be posted, AGENCY: Food and Drug Administration, such as medical information, your or information that you do not wish to be HHS. anyone else’s Social Security number, or made publicly available, submit your ACTION: Notice. confidential business information, such comments only as a written/paper as a manufacturing process. Please note submission. You should submit two SUMMARY: The Food and Drug that if you include your name, contact copies total. One copy will include the Administration (FDA) has determined information, or other information that information you claim to be confidential the regulatory review period for identifies you in the body of your with a heading or cover note that states NUCALA and is publishing this notice comments, that information will be ‘‘THIS DOCUMENT CONTAINS of that determination as required by posted on https://www.regulations.gov. CONFIDENTIAL INFORMATION.’’ The law. FDA has made the determination • If you want to submit a comment Agency will review this copy, including because of the submission of an with confidential information that you the claimed confidential information, in application to the Director of the U.S. do not wish to be made available to the its consideration of comments. The Patent and Trademark Office (USPTO), public, submit the comment as a second copy, which will have the Department of Commerce, for the written/paper submission and in the claimed confidential information extension of a patent which claims that manner detailed (see ‘‘Written/Paper redacted/blacked out, will be available human biological product. Submissions’’ and ‘‘Instructions’’). for public viewing and posted on DATES: Anyone with knowledge that any https://www.regulations.gov. Submit Written/Paper Submissions pmangrum on DSK3GDR082PROD with NOTICES of the dates as published (see the both copies to the Division of Dockets SUPPLEMENTARY INFORMATION section) are Submit written/paper submissions as Management. If you do not wish your incorrect may submit either electronic follows: name and contact information to be or written comments and ask for a • Mail/Hand delivery/Courier (for made publicly available, you can redetermination by February 13, 2017. written/paper submissions): Division of provide this information on the cover Furthermore, any interested person may Dockets Management (HFA–305), Food sheet and not in the body of your petition FDA for a determination and Drug Administration, 5630 Fishers comments and you must identify this regarding whether the applicant for Lane, Rm. 1061, Rockville, MD 20852. information as ‘‘confidential.’’ Any VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1

Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 89947 information marked as ‘‘confidential’’ period for a human biological product In its application for patent extension, will not be disclosed except in will include all of the testing phase and this applicant seeks 5 years of patent accordance with 21 CFR 10.20 and other approval phase as specified in 35 U.S.C. term extension. applicable disclosure law. For more 156(g)(1)(B). FDA has approved for marketing the III. Petitions information about FDA’s posting of comments to public dockets, see 80 FR human biologic product NUCALA Anyone with knowledge that any of 56469, September 18, 2015, or access (mepolizumab). NUCALA is indicated the dates as published are incorrect may the information at: http://www.fda.gov/ for add-on maintenance treatment of submit either electronic or written regulatoryinformation/dockets/ patients with severe asthma aged 12 comments and ask for a redetermination default.htm. years and older, and with an (see DATES). Furthermore, any interested Docket: For access to the docket to eosinophilic phenotype. Subsequent to person may petition FDA for a read background documents or the this approval, the USPTO received a determination regarding whether the electronic and written/paper comments patent term restoration application for applicant for extension acted with due received, go to https:// NUCALA (U.S. Patent No. 5,693,323) diligence during the regulatory review www.regulations.gov and insert the from GlaxoSmithKline LLC, and the period. To meet its burden, the petition docket number, found in brackets in the USPTO requested FDA’s assistance in must be timely (see DATES) and contain heading of this document, into the determining this patent’s eligibility for sufficient facts to merit an FDA ‘‘Search’’ box and follow the prompts patent term restoration. In a letter dated investigation. (See H. Rept. 857, part 1, and/or go to the Division of Dockets May 10, 2016, FDA advised the USPTO 98th Cong., 2d sess., pp. 41–42, 1984.) Management, 5630 Fishers Lane, Rm. that this human biological product had Petitions should be in the format 1061, Rockville, MD 20852. undergone a regulatory review period specified in 21 CFR 10.30. FOR FURTHER INFORMATION CONTACT: and that the approval of NUCALA Submit petitions electronically to Beverly Friedman, Office of Regulatory represented the first permitted https://www.regulations.gov at Docket Policy, Food and Drug Administration, commercial marketing or use of the No. FDA–2013–S–0610. Submit written 10903 New Hampshire Ave., Bldg. 51, product. Thereafter, the USPTO petitions (two copies are required) to the Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the Division of Dockets Management (HFA– 301–796–3600. product’s regulatory review period. 305), Food and Drug Administration, II. Determination of Regulatory Review 5630 Fishers Lane, Rm. 1061, Rockville, SUPPLEMENTARY INFORMATION: Period MD 20852. I. Background Dated: December 8, 2016. FDA has determined that the The Drug Price Competition and applicable regulatory review period for Leslie Kux, Patent Term Restoration Act of 1984 NUCALA is 6,862 days. Of this time, Associate Commissioner for Policy. (Pub. L. 98–417) and the Generic 6,496 days occurred during the testing [FR Doc. 2016–29838 Filed 12–12–16; 8:45 am] Animal Drug and Patent Term phase of the regulatory review period, BILLING CODE 4164–01–P Restoration Act (Pub. L. 100–670) while 366 days occurred during the generally provide that a patent may be approval phase. These periods of time extended for a period of up to 5 years were derived from the following dates: DEPARTMENT OF HEALTH AND so long as the patented item (human 1. The date an exemption under HUMAN SERVICES drug product, animal drug product, section 505(i) of the Federal Food, Drug, medical device, food additive, or color and Cosmetic Act (21 U.S.C. 355(i)) Food and Drug Administration additive) was subject to regulatory became effective: January 22, 1997. The [Docket No. FDA–2013–N–0764] review by FDA before the item was applicant claims January 21, 1997, as marketed. Under these acts, a product’s the date the investigational new drug Agency Information Collection regulatory review period forms the basis application (IND) became effective. Activities; Submission for Office of for determining the amount of extension However, FDA records indicate that the Management and Budget Review; an applicant may receive. IND effective date was January 22, 1997, Comment Request; Animal Feed A regulatory review period consists of which was 30 days after FDA receipt of Regulatory Program Standards two periods of time: A testing phase and the IND. an approval phase. For human 2. The date the application was AGENCY: Food and Drug Administration, biological products, the testing phase initially submitted with respect to the HHS. begins when the exemption to permit human biological product under section ACTION: Notice. the clinical investigations of the 351 of the Public Health Service Act (42 biological product becomes effective SUMMARY: The Food and Drug U.S.C. 262): November 4, 2014. FDA has and runs until the approval phase Administration (FDA) is announcing verified the applicant’s claim that the begins. The approval phase starts with that a proposed collection of biologics license application (BLA) for the initial submission of an application information has been submitted to the NUCALA (BLA 125526) was initially to market the human biological product Office of Management and Budget submitted on November 4, 2014. and continues until FDA grants 3. The date the application was (OMB) for review and clearance under permission to market the biological approved: November 4, 2015. FDA has the Paperwork Reduction Act of 1995. product. Although only a portion of a verified the applicant’s claim that BLA DATES: Fax written comments on the collection of information by January 12, pmangrum on DSK3GDR082PROD with NOTICES regulatory review period may count 125526 was approved on November 4, toward the actual amount of extension 2015. 2017. that the Director of the USPTO may This determination of the regulatory ADDRESSES: To ensure that comments on award (for example, half the testing review period establishes the maximum the information collection are received, phase must be subtracted as well as any potential length of a patent extension. OMB recommends that written time that may have occurred before the However, the USPTO applies several comments be faxed to the Office of patent was issued), FDA’s determination statutory limitations in its calculations Information and Regulatory Affairs, of the length of a regulatory review of the actual period for patent extension. OMB, Attn: FDA Desk Officer, FAX: VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1


Document Created: 2016-12-13 02:44:45
Document Modified: 2016-12-13 02:44:45
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 13, 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 12, 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 89946 
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