83_FR_7075 83 FR 7042 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOVANTIK

83 FR 7042 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOVANTIK

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 33 (February 16, 2018)

Page Range7042-7043
FR Document2018-03245

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOVANTIK 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 33 (Friday, February 16, 2018) 
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7042-7043]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-3856; FDA-2015-E-3857]


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

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 MOVANTIK 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 (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by April 
17, 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 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 17, 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. 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 15, 2018. See ``Petitions'' in the 
SUPPLEMENTARY INFORMATION section for more information.

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 2015-E-3856 and FDA 2015-E-3857 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; MOVANTIK.'' 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

[[Page 7043]]

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: 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 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 MOVANTIK 
(naloxegol oxalate). MOVANTIK is indicated for the treatment of opioid-
induced constipation in adult patients with chronic non-cancer pain. 
Subsequent to this approval, the USPTO received patent term restoration 
applications for MOVANTIK (U.S. Patent Nos. 7,662,365 and 7,786,133) 
from Nektar Therapeutics, and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated October 30, 2015, FDA advised the USPTO that this human 
drug product had undergone a regulatory review period and that the 
approval of MOVANTIK 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 
MOVANTIK is 2,493 days. Of this time, 2,127 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: November 21, 2007. The applicant claims October 22, 2007, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was November 21, 2007, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: September 
16, 2013. FDA has verified the applicant's claim that the new drug 
application (NDA) for MOVANTIK (NDA 204760) was initially submitted on 
September 16, 2013.
    3. The date the application was approved: September 16, 2014. FDA 
has verified the applicant's claim that NDA 204760 was approved on 
September 16, 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 applications for patent extension, 
this applicant seeks 1,020 days or 272 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 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03245 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P

7042 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices Health care professionals and DEPARTMENT OF HEALTH AND including attachments, to https:// organizations are encouraged to respond HUMAN SERVICES www.regulations.gov will be posted to to this RFI by submitting a written the docket unchanged. Because your statement and supporting explanatory Food and Drug Administration comment will be made public, you are materials to the email or mailing [Docket Nos. FDA–2015–E–3856; FDA– solely responsible for ensuring that your address listed above by February 28, 2015–E–3857] comment does not include any 2018. Supporting materials might confidential information that you or a include charters for quality and safety Determination of Regulatory Review third party may not wish to be posted, improvement committees, data use Period for Purposes of Patent such as medical information, your or Extension; MOVANTIK anyone else’s Social Security number, or agreements for learning collaboratives, confidential business information, such population health metrics and reports, AGENCY: Food and Drug Administration, as a manufacturing process. Please note or guidelines for the use of evidence- HHS. that if you include your name, contact based practices. When responding to ACTION: Notice. information, or other information that questions listed above, please clearly identifies you in the body of your indicate the number of the question that SUMMARY: The Food and Drug comments, that information will be is being addressed. AHRQ encourages Administration (FDA or the Agency) has posted on https://www.regulations.gov. respondents to include a description of determined the regulatory review period • If you want to submit a comment their health care delivery organization at for MOVANTIK and is publishing this with confidential information that you the beginning of their response to notice of that determination as required do not wish to be made available to the provide context for the information they by law. FDA has made the public, submit the comment as a provide. determination because of the written/paper submission and in the submission of applications to the manner detailed (see ‘‘Written/Paper Request for Comments Director of the U.S. Patent and Submissions’’ and ‘‘Instructions’’). Trademark Office (USPTO), Department This RFI is for planning purposes of Commerce, for the extension of a Written/Paper Submissions only and should not be construed as a patent which claims that human drug Submit written/paper submissions as policy, solicitation for applications, or product. follows: as an obligation on the part of the • Mail/Hand delivery/Courier (for Government to provide support for any DATES: Anyone with knowledge that any written/paper submissions): Dockets ideas identified in response to it. AHRQ of the dates as published (in the Management Staff (HFA–305), Food and SUPPLEMENTARY INFORMATION section) are will use the information submitted in Drug Administration, 5630 Fishers incorrect may submit either electronic response to this RFI at its discretion and Lane, Rm. 1061, Rockville, MD 20852. or written comments and ask for a • For written/paper comments will not provide comments to any redetermination by April 17, 2018. See submitted to the Dockets Management responder’s submission. However, ‘‘Petitions’’ in the SUPPLEMENTARY Staff, FDA will post your comment, as responses to the RFI may be reflected in INFORMATION section for more future solicitation(s) or policies. The well as any attachments, except for information. information submitted, marked and information provided will be analyzed and may appear in reports. Respondents ADDRESSES: You may submit comments identified, as confidential, if submitted will not be identified in any published as follows. Please note that late, as detailed in ‘‘Instructions.’’ reports. Respondents are advised that untimely filed comments will not be Instructions: All submissions received considered. Electronic comments must must include the Docket Nos. FDA the Government is under no obligation be submitted on or before April 17, 2015–E–3856 and FDA 2015–E–3857 for to acknowledge receipt of the 2018. The https://www.regulations.gov ‘‘Determination of Regulatory Review information received or provide Period for Purposes of Patent Extension; electronic filing system will accept feedback to respondents with respect to comments until midnight Eastern Time MOVANTIK.’’ Received comments, any information submitted. No at the end of April 17, 2018. Comments those filed in a timely manner (see proprietary, classified, confidential, or received by mail/hand delivery/courier ADDRESSES), will be placed in the docket sensitive information should be (for written/paper submissions) will be and, except for those submitted as included in your response. The considered timely if they are ‘‘Confidential Submissions,’’ publicly Government reserves the right to use postmarked or the delivery service viewable at https://www.regulations.gov any non-proprietary technical acceptance receipt is on or before that or at the Dockets Management Staff information in any resultant date. Furthermore, any interested between 9 a.m. and 4 p.m., Monday solicitation(s). The contents of all person may petition FDA for a through Friday. submissions will be made available to determination regarding whether the • Confidential Submissions—To the public upon request. Materials applicant for extension acted with due submit a comment with confidential submitted must be publicly available or diligence during the regulatory review information that you do not wish to be can be made public. period by August 15, 2018. See made publicly available, submit your ‘‘Petitions’’ in the SUPPLEMENTARY comments only as a written/paper Gopal Khanna, submission. You should submit two INFORMATION section for more Director. information. copies total. One copy will include the [FR Doc. 2018–03243 Filed 2–15–18; 8:45 am] information you claim to be confidential daltland on DSKBBV9HB2PROD with NOTICES Electronic Submissions with a heading or cover note that states BILLING CODE 4160–90–P Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS following way: CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including https://www.regulations.gov. Follow the the claimed confidential information, in instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1

Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7043 claimed confidential information product and continues until FDA grants 3. The date the application was redacted/blacked out, will be available permission to market the drug product. approved: September 16, 2014. FDA has for public viewing and posted on Although only a portion of a regulatory verified the applicant’s claim that NDA https://www.regulations.gov. Submit review period may count toward the 204760 was approved on September 16, both copies to the Dockets Management actual amount of extension that the 2014. Staff. If you do not wish your name and Director of USPTO may award (for This determination of the regulatory contact information to be made publicly example, half the testing phase must be review period establishes the maximum available, you can provide this subtracted as well as any time that may potential length of a patent extension. information on the cover sheet and not have occurred before the patent was However, the USPTO applies several in the body of your comments and you issued), FDA’s determination of the statutory limitations in its calculations must identify this information as length of a regulatory review period for of the actual period for patent extension. ‘‘confidential.’’ Any information marked a human drug product will include all In its applications for patent extension, as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase this applicant seeks 1,020 days or 272 except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). days of patent term extension. CFR 10.20) and other applicable FDA has approved for marketing the III. Petitions disclosure law. For more information human drug product MOVANTIK about FDA’s posting of comments to (naloxegol oxalate). MOVANTIK is Anyone with knowledge that any of public dockets, see 80 FR 56469, indicated for the treatment of opioid- the dates as published are incorrect may September 18, 2015, or access the induced constipation in adult patients submit either electronic or written information at: http://www.fda.gov/ with chronic non-cancer pain. comments and, under 21 CFR 60.24, ask regulatoryinformation/dockets/ Subsequent to this approval, the USPTO for a redetermination (see DATES). default.htm. received patent term restoration Furthermore, as specified in § 60.30 (21 Docket: For access to the docket to applications for MOVANTIK (U.S. CFR 60.30), any interested person may read background documents or the Patent Nos. 7,662,365 and 7,786,133) petition FDA for a determination electronic and written/paper comments from Nektar Therapeutics, and the regarding whether the applicant for received, go to https:// USPTO requested FDA’s assistance in extension acted with due diligence www.regulations.gov and insert the determining the patents’ eligibility for during the regulatory review period. To docket number, found in brackets in the patent term restoration. In a letter dated meet its burden, the petition must heading of this document, into the October 30, 2015, FDA advised the comply with all the requirements of ‘‘Search’’ box and follow the prompts USPTO that this human drug product § 60.30, including but not limited to: and/or go to the Dockets Management had undergone a regulatory review Must be timely (see DATES), must be Staff, 5630 Fishers Lane, Rm. 1061, period and that the approval of filed in accordance with § 10.20, must Rockville, MD 20852. MOVANTIK represented the first contain sufficient facts to merit an FDA FOR FURTHER INFORMATION CONTACT: permitted commercial marketing or use investigation, and must certify that a Beverly Friedman, Office of Regulatory of the product. Thereafter, the USPTO true and complete copy of the petition Policy, Food and Drug Administration, requested that FDA determine the has been served upon the patent 10903 New Hampshire Ave., Bldg. 51, product’s regulatory review period. applicant. (See H. Rept. 857, part 1, 98th Rm. 6250, Silver Spring, MD 20993, Cong., 2d sess., pp. 41–42, 1984.) II. Determination of Regulatory Review Petitions should be in the format 301–796–3600. Period SUPPLEMENTARY INFORMATION: specified in 21 CFR 10.30. FDA has determined that the Submit petitions electronically to I. Background applicable regulatory review period for https://www.regulations.gov at Docket The Drug Price Competition and MOVANTIK is 2,493 days. Of this time, No. FDA–2013–S–0610. Submit written Patent Term Restoration Act of 1984 2,127 days occurred during the testing petitions (two copies are required) to the (Pub. L. 98–417) and the Generic phase of the regulatory review period, Dockets Management Staff (HFA–305), Animal Drug and Patent Term while 366 days occurred during the Food and Drug Administration, 5630 Restoration Act (Pub. L. 100–670) approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD generally provide that a patent may be were derived from the following dates: 20852. extended for a period of up to 5 years 1. The date an exemption under Dated: February 13, 2018. so long as the patented item (human section 505(i) of the Federal Food, Drug, Leslie Kux, drug product, animal drug product, and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy. medical device, food additive, or color U.S.C. 355(i)) became effective: [FR Doc. 2018–03245 Filed 2–15–18; 8:45 am] additive) was subject to regulatory November 21, 2007. The applicant BILLING CODE 4164–01–P review by FDA before the item was claims October 22, 2007, as the date the marketed. Under these acts, a product’s investigational new drug application regulatory review period forms the basis (IND) became effective. However, FDA DEPARTMENT OF HEALTH AND for determining the amount of extension records indicate that the IND effective HUMAN SERVICES an applicant may receive. date was November 21, 2007, which was A regulatory review period consists of 30 days after FDA receipt of the IND. Food and Drug Administration two periods of time: A testing phase and 2. The date the application was an approval phase. For human drug initially submitted with respect to the [Docket No. FDA–2018–D–0481] daltland on DSKBBV9HB2PROD with NOTICES products, the testing phase begins when human drug product under section Submission of Content Necessary for the exemption to permit the clinical 505(b) of the FD&C Act: September 16, Bioresearch Monitoring Inspection investigations of the drug becomes 2013. FDA has verified the applicant’s Planning for the Center of Drug effective and runs until the approval claim that the new drug application Evaluation and Research; Availability phase begins. The approval phase starts (NDA) for MOVANTIK (NDA 204760) with the initial submission of an was initially submitted on September AGENCY: Food and Drug Administration, application to market the human drug 16, 2013. HHS. VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1


Document Created: 2018-02-16 00:55:22
Document Modified: 2018-02-16 00:55:22
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 17, 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 7042 
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