83_FR_5129 83 FR 5105 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIBERZI

83 FR 5105 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIBERZI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 24 (February 5, 2018)

Page Range5105-5106
FR Document2018-02187

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VIBERZI 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 24 (Monday, February 5, 2018) 
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5105-5106]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1276; FDA-2016-E-1277; and FDA-2016-E-1278]


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

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 VIBERZI 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 
6, 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 6, 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 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 6, 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-1276; FDA-2016-E-1277 and FDA-2016-E-1278 for 
``Determination of Regulatory Review Period for Purposes of Patent 
Extension; VIBERZI.'' 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

[[Page 5106]]

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 withSec.  
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 http://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 VIBERZI 
(eluxadoline). VIBERZI is indicated in adults for the treatment of 
irritable bowel syndrome with diarrhea. Subsequent to this approval, 
the USPTO received patent term restoration applications for VIBERZI 
(U.S. Patent Nos. 7,741,356; 8,344,011; and 8,609,709) from Janssen 
Pharmaceutica, N.V., and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated August 12, 2016, FDA advised the USPTO that this human 
drug product had undergone a regulatory review period and that the 
approval of VIBERZI 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 
VIBERZI is 2,716 days. Of this time, 2,381 days occurred during the 
testing phase of the regulatory review period, while 335 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: December 21, 2007. FDA has verified the applicant's claim 
that December 21, 2007, is the date the investigational new drug 
application (IND) became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: June 27, 
2014. The applicant claims June 26, 2014, as the date the new drug 
application (NDA) for VIBERZI was initially submitted. However, FDA 
records indicate that NDA 206940 was submitted on July 27, 2014, which 
is considered to be the NDA initially submitted date.
    3. The date the application was approved: May 27, 2015. FDA has 
verified the applicant's claims that NDA 206940 was approved on May 27, 
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 428 days, 606 days, or 431 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 Nos. 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 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02187 Filed 2-2-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices 5105 ANNUAL BURDEN ESTIMATES [This information collection request is for 3 years] Average Total Annual Number of Annual burden Instrument number of number of responses per burden hours per respondents respondents respondent hours response 1. National Evaluation 15-Month Follow-up Survey ............ 10,400 3,467 1 1 3,467 Estimated Total Annual Burden Director of the U.S. Patent and comments, that information will be Hours: 3,467. Trademark Office (USPTO), Department posted on https://www.regulations.gov. Additional Information: Copies of the of Commerce, for the extension of a • If you want to submit a comment proposed collection may be obtained by patent which claims that human drug with confidential information that you writing to the Administration for product. do not wish to be made available to the Children and Families, Office of public, submit the comment as a DATES: Anyone with knowledge that any Planning, Research and Evaluation, 330 written/paper submission and in the of the dates as published (in the C Street SW, Washington, DC 20201, manner detailed (see ‘‘Written/Paper SUPPLEMENTARY INFORMATION section) are Attn: OPRE Reports Clearance Officer. Submissions’’ and ‘‘Instructions’’). incorrect may submit either electronic All requests should be identified by the or written comments and ask for a Written/Paper Submissions title of the information collection. Email redetermination by April 6, 2018. Submit written/paper submissions as address: OPREinfocollection@ Furthermore, any interested person may follows: acf.hhs.gov. OMB Comment: OMB is required to petition FDA for a determination • Mail/Hand delivery/Courier (for make a decision concerning the regarding whether the applicant for written/paper submissions): Dockets collection of information between 30 extension acted with due diligence Management Staff (HFA–305), Food and and 60 days after publication of this during the regulatory review period by Drug Administration, 5630 Fishers document in the Federal Register. August 6, 2018. See ‘‘Petitions’’ in the Lane, Rm. 1061, Rockville, MD 20852. SUPPLEMENTARY INFORMATION section for • For written/paper comments Therefore, a comment is best assured of having its full effect if OMB receives it more information. submitted to the Dockets Management within 30 days of publication. Written ADDRESSES: You may submit comments Staff, FDA will post your comment, as comments and recommendations for the as follows. Please note that late, well as any attachments, except for proposed information collection should untimely filed comments will not be information submitted, marked and be sent directly to the following: Office considered. Electronic comments must identified, as confidential, if submitted of Management and Budget Paperwork be submitted on or before April 6, 2018. as detailed in ‘‘Instructions.’’ Reduction Project, Email: OIRA_ The https://www.regulations.gov Instructions: All submissions received SUBMISSION@OMB.EOP.GOV, Attn: electronic filing system will accept must include the Docket Nos. FDA– Desk Officer for the Administration for comments until midnight Eastern Time 2016–E–1276; FDA–2016–E–1277 and Children and Families. at the end of April 6, 2018. Comments FDA–2016–E–1278 for ‘‘Determination received by mail/hand delivery/courier of Regulatory Review Period for Mary Jones, (for written/paper submissions) will be Purposes of Patent Extension; ACF/OPRE Certifying Officer. considered timely if they are VIBERZI.’’ Received comments, those [FR Doc. 2018–02238 Filed 2–2–18; 8:45 am] postmarked or the delivery service filed in a timely manner (see BILLING CODE 4184–72–P acceptance receipt is on or before that ADDRESSES), will be placed in the docket date. and, except for those submitted as ‘‘Confidential Submissions,’’ publicly DEPARTMENT OF HEALTH AND Electronic Submissions viewable at https://www.regulations.gov HUMAN SERVICES Submit electronic comments in the or at the Dockets Management Staff following way: between 9 a.m. and 4 p.m., Monday Food and Drug Administration • Federal eRulemaking Portal: through Friday. [Docket Nos. FDA–2016–E–1276; FDA– https://www.regulations.gov. Follow the • Confidential Submissions—To 2016–E–1277; and FDA–2016–E–1278] instructions for submitting comments. submit a comment with confidential Comments submitted electronically, information that you do not wish to be Determination of Regulatory Review including attachments, to https:// made publicly available, submit your Period for Purposes of Patent www.regulations.gov will be posted to comments only as a written/paper Extension; VIBERZI the docket unchanged. Because your submission. You should submit two AGENCY: Food and Drug Administration, comment will be made public, you are copies total. One copy will include the HHS. solely responsible for ensuring that your information you claim to be confidential ACTION: Notice. comment does not include any with a heading or cover note that states confidential information that you or a ‘‘THIS DOCUMENT CONTAINS SUMMARY: The Food and Drug third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The sradovich on DSK3GMQ082PROD with NOTICES Administration (FDA or the Agency) has such as medical information, your or Agency will review this copy, including determined the regulatory review period anyone else’s Social Security number, or the claimed confidential information, in for VIBERZI and is publishing this confidential business information, such its consideration of comments. The notice of that determination as required as a manufacturing process. Please note second copy, which will have the by law. FDA has made the that if you include your name, contact claimed confidential information determination because of the information, or other information that redacted/blacked out, will be available submission of an application to the identifies you in the body of your for public viewing and posted on VerDate Sep<11>2014 18:08 Feb 02, 2018 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\05FEN1.SGM 05FEN1

5106 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices https://www.regulations.gov. Submit review period may count toward the This determination of the regulatory both copies to the Dockets Management actual amount of extension that the review period establishes the maximum Staff. If you do not wish your name and Director of USPTO may award (for potential length of a patent extension. contact information to be made publicly example, half the testing phase must be However, the USPTO applies several available, you can provide this subtracted as well as any time that may statutory limitations in its calculations information on the cover sheet and not have occurred before the patent was of the actual period for patent extension. in the body of your comments and you issued), FDA’s determination of the In its applications for patent extension, must identify this information as length of a regulatory review period for this applicant seeks 428 days, 606 days, ‘‘confidential.’’ Any information marked a human drug product will include all or 431 days of patent term extension. as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase III. Petitions except in accordance with§ 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). CFR 10.20) and other applicable FDA has approved for marketing the Anyone with knowledge that any of disclosure law. For more information human drug product VIBERZI the dates as published are incorrect may about FDA’s posting of comments to (eluxadoline). VIBERZI is indicated in submit either electronic or written public dockets, see 80 FR 56469, adults for the treatment of irritable comments and, under 21 CFR 60.24, ask September 18, 2015, or access the bowel syndrome with diarrhea. for a redetermination (see DATES). information at: https://www.gpo.gov/ Subsequent to this approval, the USPTO Furthermore, as specified in § 60.30 (21 fdsys/pkg/FR-2015-09-18/pdf/2015- received patent term restoration CFR 60.30), any interested person may 23389.pdf. applications for VIBERZI (U.S. Patent petition FDA for a determination Docket: For access to the docket to Nos. 7,741,356; 8,344,011; and regarding whether the applicant for read background documents or the 8,609,709) from Janssen Pharmaceutica, extension acted with due diligence electronic and written/paper comments N.V., and the USPTO requested FDA’s during the regulatory review period. To received, go to http:// assistance in determining the patents’ meet its burden, the petition must www.regulations.gov and insert the comply with all the requirements of eligibility for patent term restoration. In docket number, found in brackets in the § 60.30, including but not limited to: a letter dated August 12, 2016, FDA heading of this document, into the must be timely (see DATES), must be advised the USPTO that this human ‘‘Search’’ box and follow the prompts filed in accordance with § 10.20, must drug product had undergone a and/or go to the Dockets Management contain sufficient facts to merit an FDA regulatory review period and that the Staff, 5630 Fishers Lane, Rm. 1061, investigation, and must certify that a approval of VIBERZI represented the Rockville, MD 20852. true and complete copy of the petition first permitted commercial marketing or has been served upon the patent FOR FURTHER INFORMATION CONTACT: use of the product. Thereafter, the applicant. (See H. Rept. 857, part 1, 98th Beverly Friedman, Office of Regulatory USPTO requested that FDA determine Cong., 2d sess., pp. 41–42, 1984.) Policy, Food and Drug Administration, the product’s regulatory review period. Petitions should be in the format 10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review specified in 21 CFR 10.30. Rm. 6250, Silver Spring, MD 20993, Period Submit petitions electronically to 301–796–3600. https://www.regulations.gov at Docket SUPPLEMENTARY INFORMATION: FDA has determined that the Nos. FDA–2013–S–0610. Submit written applicable regulatory review period for I. Background petitions (two copies are required) to the VIBERZI is 2,716 days. Of this time, Dockets Management Staff (HFA–305), The Drug Price Competition and 2,381 days occurred during the testing Food and Drug Administration, 5630 Patent Term Restoration Act of 1984 phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD (Pub. L. 98–417) and the Generic while 335 days occurred during the 20852. Animal Drug and Patent Term approval phase. These periods of time were derived from the following dates: Dated: January 30, 2018. Restoration Act (Pub. L. 100–670) generally provide that a patent may be 1. The date an exemption under Leslie Kux, extended for a period of up to 5 years section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. so long as the patented item (human and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2018–02187 Filed 2–2–18; 8:45 am] drug product, animal drug product, U.S.C. 355(i)) became effective: BILLING CODE 4164–01–P medical device, food additive, or color December 21, 2007. FDA has verified additive) was subject to regulatory the applicant’s claim that December 21, review by FDA before the item was 2007, is the date the investigational new DEPARTMENT OF HEALTH AND marketed. Under these acts, a product’s drug application (IND) became effective. HUMAN SERVICES regulatory review period forms the basis 2. The date the application was initially submitted with respect to the Food and Drug Administration for determining the amount of extension an applicant may receive. human drug product under section [Docket No. FDA–2018–D–0388] A regulatory review period consists of 505(b) of the FD&C Act: June 27, 2014. two periods of time: A testing phase and The applicant claims June 26, 2014, as Hazard Analysis and Risk-Based an approval phase. For human drug the date the new drug application Preventive Controls for Food for products, the testing phase begins when (NDA) for VIBERZI was initially Animals; Draft Guidance for Industry; the exemption to permit the clinical submitted. However, FDA records Availability; Correction investigations of the drug becomes indicate that NDA 206940 was sradovich on DSK3GMQ082PROD with NOTICES AGENCY: Food and Drug Administration, effective and runs until the approval submitted on July 27, 2014, which is HHS. phase begins. The approval phase starts considered to be the NDA initially ACTION: Notice of availability; with the initial submission of an submitted date. correction. application to market the human drug 3. The date the application was product and continues until FDA grants approved: May 27, 2015. FDA has SUMMARY: The Food and Drug permission to market the drug product. verified the applicant’s claims that NDA Administration is correcting a notice Although only a portion of a regulatory 206940 was approved on May 27, 2015. entitled ‘‘Hazard Analysis and Risk- VerDate Sep<11>2014 18:08 Feb 02, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\05FEN1.SGM 05FEN1


Document Created: 2018-02-03 01:25:04
Document Modified: 2018-02-03 01:25:04
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 6, 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 6, 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 5105 
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