83_FR_6896 83 FR 6864 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZONTIVITY

83 FR 6864 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZONTIVITY

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

Page Range6864-6865
FR Document2018-03170

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZONTIVITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 83 Issue 32 (Thursday, February 15, 2018) 
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6864-6865]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03170]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-1665]


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

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 ZONTIVITY and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by April 
16, 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 August 14, 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 April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 16, 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 No. 
FDA-2015-E-1665 for ''Determination of Regulatory Review Period for 
Purposes of Patent Extension; ZONTIVITY.'' 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

[[Page 6865]]

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 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 number, 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 ZONTIVITY 
(vorapaxar sulfate). ZONTIVITY is indicated for the reduction of 
thrombotic cardiovascular events in patients with a history of 
myocardial infarction (MI) or with peripheral arterial disease (PAD). 
ZONTIVITY has been shown to reduce the rate of a combined endpoint of 
cardiovascular death, MI, stroke, and urgent coronary 
revascularization. Subsequent to this approval, the USPTO received a 
patent term restoration application for ZONTIVITY (U.S. Patent No. 
7,304,078) from Merck Sharp & Dohme Corp., and the USPTO requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated November 4, 2015, FDA advised the 
USPTO that this human drug product had undergone a regulatory review 
period and that the approval of ZONTIVITY 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 
ZONTIVITY is 3,401 days. Of this time, 3,037 days occurred during the 
testing phase of the regulatory review period, while 364 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: January 16, 2005. FDA has verified the Merck Sharp & Dohme 
Corp. claim that January 16, 2005, is the date the investigational new 
drug application became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the FD&C Act: May 10, 2013. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for ZONTIVITY (NDA 204886) was initially submitted on May 10, 
2013.
    3. The date the application was approved: May 8, 2014. FDA has 
verified the applicant's claim that NDA 204886 was approved on May 8, 
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 application for patent extension, 
this applicant seeks 1,357 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: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03170 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P

6864 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices co-crystals. The recommendations do III. Electronic Access postmarked or the delivery service not apply to materials that the Agency Persons with access to the internet acceptance receipt is on or before that has previously designated as salts, may obtain the guidance at either date. complexes, or other non-co-crystalline https://www.fda.gov/Drugs/Guidance Electronic Submissions forms. ComplianceRegulatoryInformation/ Submit electronic comments in the Co-crystals are crystalline materials Guidances/default.htm or https:// following way: composed of two or more different www.regulations.gov. • Federal eRulemaking Portal: molecules, typically active Dated: February 9, 2018. https://www.regulations.gov. Follow the pharmaceutical ingredient (API) and co- Leslie Kux, instructions for submitting comments. crystal formers (‘‘coformers’’), in the Associate Commissioner for Policy. Comments submitted electronically, same crystal lattice. Pharmaceutical co- including attachments, to https:// [FR Doc. 2018–03133 Filed 2–14–18; 8:45 am] crystals have provided opportunities for www.regulations.gov will be posted to BILLING CODE 4164–01–P engineering solid-state forms beyond the docket unchanged. Because your conventional solid-state forms of an comment will be made public, you are API, such as salts and polymorphs. Co- DEPARTMENT OF HEALTH AND solely responsible for ensuring that your crystals can be tailored to enhance drug HUMAN SERVICES comment does not include any product bioavailability and stability and confidential information that you or a to enhance the processability of APIs Food and Drug Administration third party may not wish to be posted, during drug product manufacture. such as medical information, your or [Docket No. FDA–2015–E–1665] Another advantage of co-crystals is that anyone else’s Social Security number, or they generate a diverse array of solid- Determination of Regulatory Review confidential business information, such state forms for APIs that lack ionizable Period for Purposes of Patent as a manufacturing process. Please note functional groups, which is a Extension; ZONTIVITY that if you include your name, contact prerequisite for salt formation. information, or other information that This guidance addresses the public AGENCY: Food and Drug Administration, identifies you in the body of your comments received in response to the HHS. comments, that information will be draft guidance for industry ‘‘Regulatory ACTION: Notice. posted on https://www.regulations.gov. • If you want to submit a comment Classification of Pharmaceutical Co- SUMMARY: The Food and Drug with confidential information that you Crystals’’ issued in August 2016. In Administration (FDA or the Agency) has do not wish to be made available to the response to this and other feedback from determined the regulatory review period public, submit the comment as a stakeholders, FDA has clarified the for ZONTIVITY and is publishing this written/paper submission and in the appropriate classification of co-crystals notice of that determination as required manner detailed (see ‘‘Written/Paper and addresses the concern by further by law. FDA has made the Submissions’’ and ‘‘Instructions’’). clarifying that co-crystals can be viewed determination because of the as a special case of solvates and submission of an application to the Written/Paper Submissions hydrates, wherein the second Director of the U.S. Patent and Submit written/paper submissions as component, the coformer, is not a Trademark Office (USPTO), Department follows: solvent (including water), and is of Commerce, for the extension of a • Mail/Hand delivery/Courier (for typically nonvolatile. patent which claims that human drug written/paper submissions): Dockets This guidance is being issued product. Management Staff (HFA–305), Food and consistent with FDA’s good guidance Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. practices regulation (21 CFR 10.115). of the dates as published (in the The guidance represents the current • For written/paper comments SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management thinking of FDA on ‘‘Regulatory incorrect may submit either electronic Classification of Pharmaceutical Co- Staff, FDA will post your comment, as or written comments and ask for a well as any attachments, except for Crystals.’’ It does not establish any redetermination by April 16, 2018. rights for any person and is not binding information submitted, marked and Furthermore, any interested person may identified, as confidential, if submitted on FDA or the public. You can use an petition FDA for a determination alternative approach if it satisfies the as detailed in ‘‘Instructions.’’ regarding whether the applicant for Instructions: All submissions received requirements of the applicable statutes extension acted with due diligence must include the Docket No. FDA– and regulations. This guidance is not during the regulatory review period by 2015–E–1665 for ’’Determination of subject to Executive Order 12866. August 14, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes II. Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION section for of Patent Extension; ZONTIVITY.’’ more information. Received comments, those filed in a This guidance refers to previously ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be approved collections of information as follows. Please note that late, placed in the docket and, except for found in FDA regulations. This untimely filed comments will not be those submitted as ‘‘Confidential guidance refers to information considered. Electronic comments must Submissions,’’ publicly viewable at collection provisions that are subject to be submitted on or before April 16, sradovich on DSK3GMQ082PROD with NOTICES https://www.regulations.gov or at the review by the Office of Management and 2018. The https://www.regulations.gov Dockets Management Staff between 9 Budget (OMB) under the Paperwork electronic filing system will accept a.m. and 4 p.m., Monday through Reduction Act of 1995 (44 U.S.C. 3501– comments until midnight Eastern Time Friday. 3520). The collections of information in at the end of April 16, 2018. Comments • Confidential Submissions—To 21 CFR 314.50(d)(1) and 314.94(a)(5) received by mail/hand delivery/courier submit a comment with confidential and (a)(9) have been approved under (for written/paper submissions) will be information that you do not wish to be OMB control number 0910–0001. considered timely if they are made publicly available, submit your VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1

Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6865 comments only as a written/paper for determining the amount of extension 16, 2005. FDA has verified the Merck submission. You should submit two an applicant may receive. Sharp & Dohme Corp. claim that January copies total. One copy will include the A regulatory review period consists of 16, 2005, is the date the investigational information you claim to be confidential two periods of time: A testing phase and new drug application became effective. with a heading or cover note that states an approval phase. For human drug products, the testing phase begins when 2. The date the application was ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical initially submitted with respect to the CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes human drug product under section 505 Agency will review this copy, including the claimed confidential information, in effective and runs until the approval of the FD&C Act: May 10, 2013. FDA has its consideration of comments. The phase begins. The approval phase starts verified the applicant’s claim that the second copy, which will have the with the initial submission of an new drug application (NDA) for claimed confidential information application to market the human drug ZONTIVITY (NDA 204886) was initially redacted/blacked out, will be available product and continues until FDA grants submitted on May 10, 2013. for public viewing and posted on permission to market the drug product. 3. The date the application was https://www.regulations.gov. Submit Although only a portion of a regulatory approved: May 8, 2014. FDA has both copies to the Dockets Management review period may count toward the verified the applicant’s claim that NDA Staff. If you do not wish your name and actual amount of extension that the 204886 was approved on May 8, 2014. contact information to be made publicly Director of USPTO may award (for example, half the testing phase must be This determination of the regulatory available, you can provide this review period establishes the maximum information on the cover sheet and not subtracted as well as any time that may have occurred before the patent was potential length of a patent extension. in the body of your comments and you issued), FDA’s determination of the However, the USPTO applies several must identify this information as length of a regulatory review period for statutory limitations in its calculations ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed a human drug product will include all of the actual period for patent extension. except in accordance with § 10.20 (21 of the testing phase and approval phase In its application for patent extension, CFR 10.20) and other applicable as specified in 35 U.S.C. 156(g)(1)(B). this applicant seeks 1,357 days of patent disclosure law. For more information FDA has approved for marketing the term extension. about FDA’s posting of comments to human drug product ZONTIVITY (vorapaxar sulfate). ZONTIVITY is III. Petitions public dockets, see 80 FR 56469, September 18, 2015, or access the indicated for the reduction of Anyone with knowledge that any of information at: https://www.gpo.gov/ thrombotic cardiovascular events in the dates as published are incorrect may fdsys/pkg/FR-2015-09-18/pdf/2015- patients with a history of myocardial submit either electronic or written infarction (MI) or with peripheral 23389.pdf. comments and under 21 CFR 60.24, ask arterial disease (PAD). ZONTIVITY has Docket: For access to the docket to been shown to reduce the rate of a for a redetermination (see DATES). read background documents or the combined endpoint of cardiovascular Furthermore, as specified in § 60.30 (21 electronic and written/paper comments death, MI, stroke, and urgent coronary CFR 60.30), any interested person may received, go to https:// revascularization. Subsequent to this petition FDA for a determination www.regulations.gov and insert the approval, the USPTO received a patent regarding whether the applicant for docket number, found in brackets in the term restoration application for extension acted with due diligence heading of this document, into the ZONTIVITY (U.S. Patent No. 7,304,078) during the regulatory review period. To ‘‘Search’’ box and follow the prompts from Merck Sharp & Dohme Corp., and meet its burden, the petition must and/or go to the Dockets Management the USPTO requested FDA’s assistance comply with all the requirements of Staff, 5630 Fishers Lane, Rm. 1061, in determining this patent’s eligibility § 60.30, including but not limited to: Rockville, MD 20852. for patent term restoration. In a letter Must be timely (see DATES), must be FOR FURTHER INFORMATION CONTACT: dated November 4, 2015, FDA advised filed in accordance with § 10.20, must Beverly Friedman, Office of Regulatory the USPTO that this human drug contain sufficient facts to merit an FDA Policy, Food and Drug Administration, product had undergone a regulatory investigation, and must certify that a 10903 New Hampshire Ave., Bldg. 51, review period and that the approval of true and complete copy of the petition Rm. 6250, Silver Spring, MD 20993, ZONTIVITY represented the first has been served upon the patent 301–796–3600. permitted commercial marketing or use applicant. (See H. Rept. 857, part 1, 98th of the product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.) SUPPLEMENTARY INFORMATION: requested that FDA determine the Petitions should be in the format I. Background product’s regulatory review period. specified in 21 CFR 10.30. The Drug Price Competition and II. Determination of Regulatory Review Submit petitions electronically to Patent Term Restoration Act of 1984 Period https://www.regulations.gov at Docket (Pub. L. 98–417) and the Generic FDA has determined that the No. FDA–2013–S–0610. Submit written Animal Drug and Patent Term applicable regulatory review period for petitions (two copies are required) to the Restoration Act (Pub. L. 100–670) ZONTIVITY is 3,401 days. Of this time, Dockets Management Staff (HFA–305), generally provide that a patent may be 3,037 days occurred during the testing Food and Drug Administration, 5630 extended for a period of up to 5 years Fishers Lane, Rm. 1061, Rockville, MD sradovich on DSK3GMQ082PROD with NOTICES phase of the regulatory review period, so long as the patented item (human while 364 days occurred during the 20852. drug product, animal drug product, approval phase. These periods of time Dated: February 9, 2018. medical device, food additive, or color were derived from the following dates: Leslie Kux, additive) was subject to regulatory 1. The date an exemption under review by FDA before the item was section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. marketed. Under these acts, a product’s and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2018–03170 Filed 2–14–18; 8:45 am] regulatory review period forms the basis U.S.C. 355(i)) became effective: January BILLING CODE 4164–01–P VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 E:\FR\FM\15FEN1.SGM 15FEN1


Document Created: 2018-02-15 00:20:51
Document Modified: 2018-02-15 00:20:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 August 14, 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 6864 
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