83_FR_3013 83 FR 2999 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZURAMPIC

83 FR 2999 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZURAMPIC

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 14 (January 22, 2018)

Page Range2999-3000
FR Document2018-00992

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZURAMPIC 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 drug product.

Federal Register, Volume 83 Issue 14 (Monday, January 22, 2018) 
[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Notices]
[Pages 2999-3000]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2503, FDA-2016-E-2504, FDA-2016-E-2505, FDA-
2016-E-2506, and FDA-2016-E-2507]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for ZURAMPIC 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 drug 
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 March 
23, 2018. 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 July 23, 2018. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of March 23, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2503, FDA-2016-E-2504, FDA-2016-E-2505, FDA-2016-E-2506, and 
FDA-2016-E-2507 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ZURAMPIC.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 Dockets Management Staff. 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 Sec.  10.20 (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

[[Page 3000]]

information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 numbers, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 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 ZURAMPIC 
(lesinurad). ZURAMPIC is indicated in combination with a xanthine 
oxidase inhibitor for the treatment of hyperuricemia associated with 
gout in patients who have not achieved target serum uric acid levels 
with a xanthine oxidase inhibitor alone. Subsequent to this approval, 
the USPTO received patent term restoration applications for ZURAMPIC 
(U.S. Patent Nos. 8,003,681; 8,084,483; 8,283,369; 8,357,713; and 
8,546,437) from Ardea Biosciences, Inc., and the USPTO requested FDA's 
assistance in determining the patents' eligibility for patent term 
restoration. In a letter dated November 10, 2016, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of ZURAMPIC 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 
ZURAMPIC is 2,245 days. Of this time, 1,886 days occurred during the 
testing phase of the regulatory review period, while 359 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: 
October 31, 2009. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
October 31, 2009.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: December 
29, 2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for ZURAMPIC (NDA 207988) was initially submitted on 
December 29, 2014.
    3. The date the application was approved: December 22, 2015. FDA 
has verified the applicant's claim that NDA 207988 was approved on 
December 22, 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 applications for patent extension, 
this applicant seeks 971 days, 127 days, 391 days, and 237 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, under 
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as 
specified in Sec.  60.30 (21 CFR 60.30), 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 comply with all the requirements 
of Sec.  60.30, including but not limited to: must be timely (see 
DATES), must be filed in accordance with Sec.  10.20, must contain 
sufficient facts to merit an FDA investigation, and must certify that a 
true and complete copy of the petition has been served upon the patent 
applicant. (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 Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00992 Filed 1-19-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 2999 This determination of the regulatory for ZURAMPIC and is publishing this written/paper submission and in the review period establishes the maximum notice of that determination as required manner detailed (see ‘‘Written/Paper potential length of a patent extension. by law. FDA has made the Submissions’’ and ‘‘Instructions’’). However, the USPTO applies several determination because of the Written/Paper Submissions statutory limitations in its calculations submission of applications to the of the actual period for patent extension. Director of the U.S. Patent and Submit written/paper submissions as In its application for patent extension, Trademark Office (USPTO), Department follows: this applicant seeks 576 days of patent of Commerce, for the extension of a • Mail/Hand delivery/Courier (for term extension. patent which claims that human drug written/paper submissions): Dockets product. Management Staff (HFA–305), Food and III. Petitions Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. Anyone with knowledge that any of the dates as published are incorrect may of the dates as published (see the • For written/paper comments SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management submit either electronic or written incorrect may submit either electronic Staff, FDA will post your comment, as comments and, under 21 CFR 60.24, ask or written comments and ask for a well as any attachments, except for for a redetermination (see DATES). redetermination by March 23, 2018. information submitted, marked and Furthermore, as specified in § 60.30 (21 Furthermore, any interested person may identified, as confidential, if submitted CFR 60.30), any interested person may petition FDA for a determination as detailed in ‘‘Instructions.’’ petition FDA for a determination regarding whether the applicant for Instructions: All submissions received regarding whether the applicant for extension acted with due diligence must include the Docket Nos. FDA– extension acted with due diligence during the regulatory review period by 2016–E–2503, FDA–2016–E–2504, during the regulatory review period. To July 23, 2018. See ‘‘Petitions’’ in the FDA–2016–E–2505, FDA–2016–E–2506, meet its burden, the petition must SUPPLEMENTARY INFORMATION section for and FDA–2016–E–2507 for comply with all the requirements of more information. ‘‘Determination of Regulatory Review § 60.30, including but not limited to: Must be timely (see DATES), must be ADDRESSES: You may submit comments Period for Purposes of Patent Extension; filed in accordance with § 10.20, must as follows. Please note that late, ZURAMPIC.’’ Received comments, untimely filed comments will not be those filed in a timely manner (see contain sufficient facts to merit an FDA considered. Electronic comments must ADDRESSES), will be placed in the docket investigation, and must certify that a be submitted on or before March 23, and, except for those submitted as true and complete copy of the petition 2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly has been served upon the patent electronic filing system will accept viewable at https://www.regulations.gov applicant. (See H. Rept. 857, part 1, 98th comments until midnight Eastern Time or at the Dockets Management Staff Cong., 2d sess., pp. 41–42, 1984.) at the end of March 23, 2018. Comments between 9 a.m. and 4 p.m., Monday Petitions should be in the format received by mail/hand delivery/courier through Friday. specified in 21 CFR 10.30. • Confidential Submissions—To Submit petitions electronically to (for written/paper submissions) will be considered timely if they are submit a comment with confidential https://www.regulations.gov at Docket postmarked or the delivery service information that you do not wish to be No. FDA–2013–S–0610. Submit written acceptance receipt is on or before that made publicly available, submit your petitions (two copies are required) to the date. comments only as a written/paper Dockets Management Staff (HFA–305), submission. You should submit two Food and Drug Administration, 5630 Electronic Submissions copies total. One copy will include the Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the information you claim to be confidential 20852. following way: with a heading or cover note that states Dated: January 16, 2018. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS Leslie Kux, https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The Associate Commissioner for Policy. instructions for submitting comments. Agency will review this copy, including [FR Doc. 2018–00995 Filed 1–19–18; 8:45 am] Comments submitted electronically, the claimed confidential information, in BILLING CODE 4164–01–P including attachments, to https:// its consideration of comments. The www.regulations.gov will be posted to second copy, which will have the the docket unchanged. Because your claimed confidential information DEPARTMENT OF HEALTH AND comment will be made public, you are redacted/blacked out, will be available HUMAN SERVICES solely responsible for ensuring that your for public viewing and posted on comment does not include any https://www.regulations.gov. Submit Food and Drug Administration confidential information that you or a both copies to the Dockets Management [Docket Nos. FDA–2016–E–2503, FDA– third party may not wish to be posted, Staff. If you do not wish your name and 2016–E–2504, FDA–2016–E–2505, FDA– such as medical information, your or contact information to be made publicly 2016–E–2506, and FDA–2016–E–2507] anyone else’s Social Security number, or available, you can provide this confidential business information, such information on the cover sheet and not Determination of Regulatory Review as a manufacturing process. Please note in the body of your comments and you Period for Purposes of Patent that if you include your name, contact must identify this information as Extension; ZURAMPIC information, or other information that ‘‘confidential.’’ Any information marked ethrower on DSK3G9T082PROD with NOTICES AGENCY: Food and Drug Administration, identifies you in the body of your as ‘‘confidential’’ will not be disclosed HHS. comments, that information will be except in accordance with § 10.20 (21 ACTION: Notice. posted on https://www.regulations.gov. CFR 10.20) and other applicable • If you want to submit a comment disclosure law. For more information SUMMARY: The Food and Drug with confidential information that you about FDA’s posting of comments to Administration (FDA or the Agency) has do not wish to be made available to the public dockets, see 80 FR 56469, determined the regulatory review period public, submit the comment as a September 18, 2015, or access the VerDate Sep<11>2014 19:00 Jan 19, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1

3000 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices information at: https://www.gpo.gov/ hyperuricemia associated with gout in comments and, under 21 CFR 60.24, ask fdsys/pkg/FR-2015-09-18/pdf/2015- patients who have not achieved target for a redetermination (see DATES). 23389.pdf. serum uric acid levels with a xanthine Furthermore, as specified in § 60.30 (21 Docket: For access to the docket to oxidase inhibitor alone. Subsequent to CFR 60.30), any interested person may read background documents or the this approval, the USPTO received petition FDA for a determination electronic and written/paper comments patent term restoration applications for regarding whether the applicant for received, go to https:// ZURAMPIC (U.S. Patent Nos. 8,003,681; extension acted with due diligence www.regulations.gov and insert the 8,084,483; 8,283,369; 8,357,713; and during the regulatory review period. To docket numbers, found in brackets in 8,546,437) from Ardea Biosciences, Inc., meet its burden, the petition must the heading of this document, into the and the USPTO requested FDA’s comply with all the requirements of ‘‘Search’’ box and follow the prompts assistance in determining the patents’ § 60.30, including but not limited to: and/or go to the Dockets Management eligibility for patent term restoration. In must be timely (see DATES), must be Staff, 5630 Fishers Lane, Rm. 1061, a letter dated November 10, 2016, FDA filed in accordance with § 10.20, must Rockville, MD 20852. advised the USPTO that this human contain sufficient facts to merit an FDA FOR FURTHER INFORMATION CONTACT: drug product had undergone a investigation, and must certify that a Beverly Friedman, Office of Regulatory regulatory review period and that the true and complete copy of the petition Policy, Food and Drug Administration, approval of ZURAMPIC represented the has been served upon the patent 10903 New Hampshire Ave., Bldg. 51, first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th Rm. 6250, Silver Spring, MD 20993, use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.) 301–796–3600. USPTO requested that FDA determine Petitions should be in the format SUPPLEMENTARY INFORMATION: the product’s regulatory review period. specified in 21 CFR 10.30. II. Determination of Regulatory Review Submit petitions electronically to I. Background https://www.regulations.gov at Docket Period The Drug Price Competition and No. FDA–2013–S–0610. Submit written FDA has determined that the petitions (two copies are required) to the Patent Term Restoration Act of 1984 applicable regulatory review period for Dockets Management Staff (HFA–305), (Pub. L. 98–417) and the Generic ZURAMPIC is 2,245 days. Of this time, Food and Drug Administration, 5630 Animal Drug and Patent Term 1,886 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD Restoration Act (Pub. L. 100–670) phase of the regulatory review period, 20852. generally provide that a patent may be while 359 days occurred during the extended for a period of up to 5 years Dated: January 16, 2018. approval phase. These periods of time so long as the patented item (human Leslie Kux, were derived from the following dates: drug product, animal drug product, 1. The date an exemption under Associate Commissioner for Policy. medical device, food additive, or color section 505(i) of the Federal Food, Drug, [FR Doc. 2018–00992 Filed 1–19–18; 8:45 am] additive) was subject to regulatory and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P review by FDA before the item was 355(i)) became effective: October 31, marketed. Under these acts, a product’s 2009. FDA has verified the applicant’s regulatory review period forms the basis claim that the date the investigational DEPARTMENT OF HEALTH AND for determining the amount of extension new drug application became effective HUMAN SERVICES an applicant may receive. was on October 31, 2009. A regulatory review period consists of 2. The date the application was Food and Drug Administration two periods of time: A testing phase and initially submitted with respect to the [Docket Nos. FDA–2016–E–2463; FDA– an approval phase. For human drug human drug product under section 2016–E–2464; FDA–2016–E–2465; and FDA– products, the testing phase begins when 505(b) of the FD&C Act: December 29, 2016–E–2466] the exemption to permit the clinical 2014. FDA has verified the applicant’s investigations of the drug becomes claim that the new drug application Determination of Regulatory Review effective and runs until the approval (NDA) for ZURAMPIC (NDA 207988) Period for Purposes of Patent phase begins. The approval phase starts was initially submitted on December 29, Extension; NINLARO with the initial submission of an 2014. application to market the human drug AGENCY: Food and Drug Administration, 3. The date the application was product and continues until FDA grants HHS. approved: December 22, 2015. FDA has permission to market the drug product. verified the applicant’s claim that NDA ACTION: Notice. Although only a portion of a regulatory 207988 was approved on December 22, review period may count toward the SUMMARY: The Food and Drug 2015. Administration (FDA or the Agency) has actual amount of extension that the This determination of the regulatory Director of USPTO may award (for determined the regulatory review period review period establishes the maximum for NINLARO and is publishing this example, half the testing phase must be potential length of a patent extension. subtracted as well as any time that may notice of that determination as required However, the USPTO applies several by law. FDA has made the have occurred before the patent was statutory limitations in its calculations issued), FDA’s determination of the determination because of the of the actual period for patent extension. submission of applications to the length of a regulatory review period for In its applications for patent extension, a human drug product will include all Director of the U.S. Patent and this applicant seeks 971 days, 127 days, ethrower on DSK3G9T082PROD with NOTICES of the testing phase and approval phase Trademark Office (USPTO), Department 391 days, and 237 days of patent term of Commerce, for the extension of a as specified in 35 U.S.C. 156(g)(1)(B). extension. FDA has approved for marketing the patent which claims that human drug human drug product ZURAMPIC III. Petitions product. (lesinurad). ZURAMPIC is indicated in Anyone with knowledge that any of DATES: Anyone with knowledge that any combination with a xanthine oxidase the dates as published are incorrect may of the dates as published (see the inhibitor for the treatment of submit either electronic or written SUPPLEMENTARY INFORMATION section) are VerDate Sep<11>2014 19:00 Jan 19, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1


Document Created: 2018-01-23 21:35:44
Document Modified: 2018-01-23 21:35:44
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 March 23, 2018. 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 July 23, 2018. 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 Citation83 FR 2999 
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