83_FR_62823 83 FR 62590 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCE

83 FR 62590 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 233 (December 4, 2018)

Page Range62590-62591
FR Document2018-26289

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRULANCE 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 233 (Tuesday, December 4, 2018) 
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62590-62591]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-4282]


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

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 TRULANCE 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 (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
February 4, 2019. 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 3, 2019. 
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 February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 4, 2019. 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-2017-E-4282 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; TRULANCE.'' 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

[[Page 62591]]

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, TRULANCE 
(plecanatide) indicated in adults for treatment of chronic idiopathic 
constipation. Subsequent to this approval, the USPTO received a patent 
term restoration application for TRULANCE (U.S. Patent No. 7,041,786) 
from Synergy Pharmaceuticals, Inc. and the USPTO requested FDA's 
assistance in determining the patent's eligibility for patent term 
restoration. In a letter dated September 20, 2017, FDA advised the 
USPTO that this human drug product had undergone a regulatory review 
period and that the approval of TRULANCE 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 
TRULANCE is 3,186 days. Of this time, 2,829 days occurred during the 
testing phase of the regulatory review period, while 357 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: 
May 2, 2008. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was May 2, 2008.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: January 
29, 2016. FDA has verified the applicant's claim that the new drug 
application (NDA) for TRULANCE (NDA 208745) was initially submitted on 
January 29, 2016.
    3. The date the application was approved: January 19, 2017. FDA has 
verified the applicant's claim that NDA 208745 was approved on January 
19, 2017.
    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 1,771 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: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26289 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P

62590 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices As described in the GDUFA II Guidances/default.htm or https:// Electronic Submissions Commitment Letter, post-CRL meetings www.regulations.gov. Submit electronic comments in the will be used by applicants ‘‘to seek Dated: November 28, 2018. following way: clarification concerning deficiencies • Federal eRulemaking Portal: Leslie Kux, identified in a CRL.’’ Under GDUFA II, https://www.regulations.gov. Follow the Associate Commissioner for Policy. post-CRL meetings are available for both instructions for submitting comments. major and minor CRLs and for first and [FR Doc. 2018–26285 Filed 12–3–18; 8:45 am] Comments submitted electronically, subsequent review cycles. FDA will BILLING CODE 4164–01–P including attachments, to https:// grant any complete post-CRL meeting www.regulations.gov will be posted to request that satisfies the criteria the docket unchanged. Because your outlined in section IV of this guidance. DEPARTMENT OF HEALTH AND HUMAN SERVICES comment will be made public, you are FDA will only grant post-CRL meeting solely responsible for ensuring that your requests that pose questions to clarify Food and Drug Administration comment does not include any identified deficiencies. Other issues, confidential information that you or a including questions requiring further [Docket No. FDA–2017–E–4282] third party may not wish to be posted, Agency review, disputes about such as medical information, your or classification of complete response Determination of Regulatory Review anyone else’s Social Security number, or amendments, or new information Period for Purposes of Patent confidential business information, such submitted by the applicant, will not be Extension; TRULANCE as a manufacturing process. Please note addressed in a post-CRL meeting. This guidance finalizes the draft that if you include your name, contact guidance announced in the Federal AGENCY: Food and Drug Administration, information, or other information that Register on October 16, 2017 (82 FR HHS. identifies you in the body of your 48093). The Agency considered comments, that information will be ACTION: Notice. comments on the draft guidance while posted on https://www.regulations.gov. finalizing the guidance. Generally, we • If you want to submit a comment SUMMARY: The Food and Drug with confidential information that you revised the draft guidance to provide Administration (FDA or the Agency) has clarifying information on the process for do not wish to be made available to the determined the regulatory review period public, submit the comment as a submitting post-CRL meeting requests for TRULANCE and is publishing this and the criteria for granting post-CRL written/paper submission and in the notice of that determination as required manner detailed (see ‘‘Written/Paper meeting requests. Changes from the by law. FDA has made the draft guidance include information on Submissions’’ and ‘‘Instructions’’). determination because of the the process for an abbreviated new drug submission of an application to the Written/Paper Submissions application (ANDA) applicant to change Director of the U.S. Patent and the list of meeting participants and Submit written/paper submissions as Trademark Office (USPTO), Department follows: clarification on when a post-CRL of Commerce, for the extension of a • Mail/Hand delivery/Courier (for meeting request may be denied. patent which claims that human drug This guidance is being issued written/paper submissions): Dockets product. Management Staff (HFA–305), Food and consistent with FDA’s good guidance practices regulation (21 CFR 10.115). Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any The guidance represents the current Lane, Rm. 1061, Rockville, MD 20852. of the dates as published (see the thinking of FDA on ‘‘Post-Complete • For written/paper comments SUPPLEMENTARY INFORMATION section) are Response Letter Meetings Between FDA submitted to the Dockets Management incorrect may submit either electronic and ANDA Applicants Under GDUFA.’’ Staff, FDA will post your comment, as or written comments and ask for a It does not establish any rights for any well as any attachments, except for redetermination by February 4, 2019. person and is not binding on FDA or the information submitted, marked and Furthermore, any interested person may public. You can use an alternative identified, as confidential, if submitted petition FDA for a determination approach if it satisfies the requirements as detailed in ‘‘Instructions.’’ regarding whether the applicant for of the applicable statutes and Instructions: All submissions received extension acted with due diligence regulations. This guidance is not subject must include the Docket No. FDA– during the regulatory review period by to Executive Order 12866. 2017–E–4282 for ‘‘Determination of June 3, 2019. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes SUPPLEMENTARY INFORMATION section for II. Paperwork Reduction Act of 1995 of Patent Extension; TRULANCE.’’ more information. This guidance refers to previously Received comments, those filed in a approved collections of information ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be found in FDA regulations. These as follows. Please note that late, placed in the docket and, except for collections of information are subject to untimely filed comments will not be those submitted as ‘‘Confidential review by the Office of Management and considered. Electronic comments must Submissions,’’ publicly viewable at Budget (OMB) under the Paperwork be submitted on or before February 4, https://www.regulations.gov or at the Reduction Act of 1995 (44 U.S.C. 3501– 2019. The https://www.regulations.gov Dockets Management Staff between 9 3520). The collections of information in electronic filing system will accept a.m. and 4 p.m., Monday through 21 CFR part 314 have been approved comments until 11:59 p.m. Eastern Time Friday. under OMB control number 0910–0001. at the end of February 4, 2019. • Confidential Submissions—To Comments received by mail/hand submit a comment with confidential III. Electronic Access delivery/courier (for written/paper information that you do not wish to be Persons with access to the internet submissions) will be considered timely made publicly available, submit your may obtain the guidance at either http:// if they are postmarked or the delivery comments only as a written/paper www.fda.gov/Drugs/Guidance service acceptance receipt is on or submission. You should submit two ComplianceRegulatoryInformation/ before that date. copies total. One copy will include the VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1

Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62591 information you claim to be confidential an approval phase. For human drug was initially submitted on January 29, with a heading or cover note that states products, the testing phase begins when 2016. ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical 3. The date the application was CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes approved: January 19, 2017. FDA has Agency will review this copy, including effective and runs until the approval verified the applicant’s claim that NDA the claimed confidential information, in phase begins. The approval phase starts 208745 was approved on January 19, its consideration of comments. The with the initial submission of an 2017. second copy, which will have the application to market the human drug This determination of the regulatory claimed confidential information product and continues until FDA grants review period establishes the maximum redacted/blacked out, will be available permission to market the drug product. potential length of a patent extension. for public viewing and posted on Although only a portion of a regulatory However, the USPTO applies several https://www.regulations.gov. Submit review period may count toward the statutory limitations in its calculations both copies to the Dockets Management actual amount of extension that the of the actual period for patent extension. Staff. If you do not wish your name and Director of USPTO may award (for In its application for patent extension, contact information to be made publicly example, half the testing phase must be this applicant seeks 1,771 days of patent available, you can provide this subtracted as well as any time that may term extension. information on the cover sheet and not have occurred before the patent was III. Petitions in the body of your comments and you issued), FDA’s determination of the length of a regulatory review period for Anyone with knowledge that any of must identify this information as a human drug product will include all the dates as published are incorrect may ‘‘confidential.’’ Any information marked of the testing phase and approval phase submit either electronic or written as ‘‘confidential’’ will not be disclosed as specified in 35 U.S.C. 156(g)(1)(B). comments and, under 21 CFR 60.24, ask except in accordance with § 10.20 (21 FDA has approved for marketing the for a redetermination (see DATES). CFR 10.20) and other applicable human drug product, TRULANCE Furthermore, as specified in § 60.30 (21 disclosure law. For more information (plecanatide) indicated in adults for CFR 60.30), any interested person may about FDA’s posting of comments to petition FDA for a determination public dockets, see 80 FR 56469, treatment of chronic idiopathic constipation. Subsequent to this regarding whether the applicant for September 18, 2015, or access the extension acted with due diligence information at: https://www.gpo.gov/ approval, the USPTO received a patent term restoration application for during the regulatory review period. To fdsys/pkg/FR-2015-09-18/pdf/2015- meet its burden, the petition must 23389.pdf. TRULANCE (U.S. Patent No. 7,041,786) from Synergy Pharmaceuticals, Inc. and comply with all the requirements of Docket: For access to the docket to § 60.30, including but not limited to: read background documents or the the USPTO requested FDA’s assistance in determining the patent’s eligibility Must be timely (see DATES), must be electronic and written/paper comments filed in accordance with § 10.20, must received, go to https:// for patent term restoration. In a letter dated September 20, 2017, FDA advised contain sufficient facts to merit an FDA www.regulations.gov and insert the investigation, and must certify that a docket number, found in brackets in the the USPTO that this human drug product had undergone a regulatory true and complete copy of the petition heading of this document, into the has been served upon the patent ‘‘Search’’ box and follow the prompts review period and that the approval of TRULANCE represented the first applicant. (See H. Rept. 857, part 1, 98th and/or go to the Dockets Management Cong., 2d sess., pp. 41–42, 1984.) Staff, 5630 Fishers Lane, Rm. 1061, permitted commercial marketing or use of the product. Thereafter, the USPTO Petitions should be in the format Rockville, MD 20852. specified in 21 CFR 10.30. requested that FDA determine the FOR FURTHER INFORMATION CONTACT: Submit petitions electronically to product’s regulatory review period. Beverly Friedman, Office of Regulatory https://www.regulations.gov at Docket Policy, Food and Drug Administration, II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written 10903 New Hampshire Ave., Bldg. 51, Period petitions (two copies are required) to the Rm. 6250, Silver Spring, MD 20993, FDA has determined that the Dockets Management Staff (HFA–305), 301–796–3600. applicable regulatory review period for Food and Drug Administration, 5630 SUPPLEMENTARY INFORMATION: TRULANCE is 3,186 days. Of this time, Fishers Lane, Rm. 1061, Rockville, MD 2,829 days occurred during the testing 20852. I. Background phase of the regulatory review period, Dated: November 28, 2018. The Drug Price Competition and while 357 days occurred during the Leslie Kux, Patent Term Restoration Act of 1984 approval phase. These periods of time Associate Commissioner for Policy. (Pub. L. 98–417) and the Generic were derived from the following dates: [FR Doc. 2018–26289 Filed 12–3–18; 8:45 am] Animal Drug and Patent Term 1. The date an exemption under BILLING CODE 4164–01–P Restoration Act (Pub. L. 100–670) section 505(i) of the Federal Food, Drug, generally provide that a patent may be and Cosmetic Act (FD&C Act) (21 U.S.C. extended for a period of up to 5 years 355(i)) became effective: May 2, 2008. DEPARTMENT OF HEALTH AND so long as the patented item (human FDA has verified the applicant’s claim HUMAN SERVICES drug product, animal drug product, that the date the investigational new medical device, food additive, or color drug application became effective was Food and Drug Administration additive) was subject to regulatory May 2, 2008. review by FDA before the item was 2. The date the application was [Docket No. FDA–2017–E–3650] marketed. Under these acts, a product’s initially submitted with respect to the Determination of Regulatory Review regulatory review period forms the basis human drug product under section Period for Purposes of Patent for determining the amount of extension 505(b) of the FD&C Act: January 29, Extension; OCALIVA an applicant may receive. 2016. FDA has verified the applicant’s A regulatory review period consists of claim that the new drug application AGENCY: Food and Drug Administration, two periods of time: A testing phase and (NDA) for TRULANCE (NDA 208745) HHS. VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1


Document Created: 2018-12-04 00:42:48
Document Modified: 2018-12-04 00:42:48
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 4, 2019. 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 3, 2019. 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 62590 
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