83_FR_4238 83 FR 4218 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIEKIRA PAK

83 FR 4218 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIEKIRA PAK

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range4218-4219
FR Document2018-01651

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VIEKIRA PAK 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 20 (Tuesday, January 30, 2018) 
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4218-4219]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01651]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0482]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; VIEKIRA PAK

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 VIEKIRA PAK 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 
2, 2018. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by July 30, 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 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 2, 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-2016-E-0482 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; VIEKIRA PAK.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the 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

[[Page 4219]]

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 VIEKIRA PAK 
(ombitasvir, paritaprevir, dasabuvir, and ritonavir). VIEKIRA PAK with 
or without ribavirin is indicated for the treatment of patients with 
genotype 1 chronic hepatitis C virus infection including those with 
compensated cirrhosis. Subsequent to this approval, the USPTO received 
a patent term restoration application for VIEKIRA PAK (U.S. Patent No. 
8,501,238) from AbbVie Inc., and the USPTO requested FDA's assistance 
in determining this patent's eligibility for patent term restoration. 
In a letter dated May 2, 2016, FDA advised the USPTO that this human 
drug product had undergone a regulatory review period and that the 
approval of VIEKIRA PAK 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 
VIEKIRA PAK is 2,391 days. Of this time, 2,148 days occurred during the 
testing phase of the regulatory review period, while 243 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: June 4, 2008. FDA has verified the applicant's claim that 
June 4, 2008, 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: April 21, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for VIEKIRA PAK (NDA 206619) was initially submitted 
on April 21, 2014.
    3. The date the application was approved: December 19, 2014. FDA 
has verified the applicant's claim that NDA 206619 was approved on 
December 19, 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 93 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are 
incorrect may submit either electronic or written comments and, under 
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as 
specified in Sec.  60.30 (21 CFR 60.30), any interested person may 
petition FDA for a determination regarding whether the applicant for 
extension acted with due diligence during the regulatory review period. 
To meet its burden, the petition must comply with all the requirements 
of Sec.  60.30, including but not limited to: Must be timely (see 
DATES), must be filed in accordance with Sec.  10.20, must contain 
sufficient facts to merit an FDA investigation, and must certify that a 
true and complete copy of the petition has been served upon the patent 
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01651 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P

4218 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Hours per Activity responses per Total hours respondents responses response respondent Requests for a QIDP Designation ....................................... 25 1.32 33 60 1,980 1 There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access considered. Electronic comments must identified, as confidential, if submitted Persons with access to the internet be submitted on or before April 2, 2018. as detailed in ‘‘Instructions.’’ may obtain the draft guidance at either The https://www.regulations.gov Instructions: All submissions received https://www.fda.gov/Drugs/Guidance electronic filing system will accept must include the Docket No. FDA– ComplianceRegulatoryInformation/ comments until midnight Eastern Time 2016–E–0482 for ‘‘Determination of Guidances/default.htm or https:// at the end of April 2, 2018. Comments Regulatory Review Period for Purposes received by mail/hand delivery/courier of Patent Extension; VIEKIRA PAK.’’ www.regulations.gov. (for written/paper submissions) will be Received comments, those filed in a Dated: January 24, 2018. considered timely if they are timely manner (see ADDRESSES), will be Leslie Kux, postmarked or the delivery service placed in the docket and, except for Associate Commissioner for Policy. acceptance receipt is on or before that those submitted as ‘‘Confidential [FR Doc. 2018–01662 Filed 1–29–18; 8:45 am] date. Submissions,’’ publicly viewable at BILLING CODE 4164–01–P https://www.regulations.gov or at the Electronic Submissions Dockets Management Staff between 9 Submit electronic comments in the a.m. and 4 p.m., Monday through DEPARTMENT OF HEALTH AND following way: Friday. HUMAN SERVICES • Confidential Submissions—To • Federal eRulemaking Portal: submit a comment with confidential https://www.regulations.gov. Follow the Food and Drug Administration information that you do not wish to be instructions for submitting comments. [Docket No. FDA–2016–E–0482] made publicly available, submit your Comments submitted electronically, comments only as a written/paper including attachments, to https:// Determination of Regulatory Review submission. You should submit two www.regulations.gov will be posted to Period for Purposes of Patent copies total. One copy will include the the docket unchanged. Because your Extension; VIEKIRA PAK information you claim to be confidential comment will be made public, you are with a heading or cover note that states AGENCY: Food and Drug Administration, solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS HHS. comment does not include any CONFIDENTIAL INFORMATION.’’ The ACTION: Notice. confidential information that you or a Agency will review this copy, including third party may not wish to be posted, the claimed confidential information, in SUMMARY: The Food and Drug such as medical information, your or its consideration of comments. The Administration (FDA or the Agency) has anyone else’s Social Security number, or second copy, which will have the determined the regulatory review period confidential business information, such claimed confidential information for VIEKIRA PAK and is publishing this as a manufacturing process. Please note redacted/blacked out, will be available notice of that determination as required that if you include your name, contact for public viewing and posted on by law. FDA has made the information, or other information that https://www.regulations.gov. Submit determination because of the identifies you in the body of your both copies to the Dockets Management submission of an application to the comments, that information will be Staff. If you do not wish your name and Director of the U.S. Patent and posted on https://www.regulations.gov. contact information to be made publicly Trademark Office (USPTO), Department • If you want to submit a comment available, you can provide this of Commerce, for the extension of a with confidential information that you information on the cover sheet and not patent which claims that human drug do not wish to be made available to the in the body of your comments and you product. public, submit the comment as a must identify this information as DATES: Anyone with knowledge that any written/paper submission and in the ‘‘confidential.’’ Any information marked of the dates as published (in the manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed SUPPLEMENTARY INFORMATION section) are Submissions’’ and ‘‘Instructions’’). except in accordance with § 10.20 (21 incorrect may submit either electronic Written/Paper Submissions CFR 10.20) and other applicable or written comments and ask for a disclosure law. For more information redetermination by April 2, 2018. Submit written/paper submissions as about FDA’s posting of comments to Furthermore, any interested person may follows: public dockets, see 80 FR 56469, petition FDA for a determination • Mail/Hand delivery/Courier (for September 18, 2015, or access the regarding whether the applicant for written/paper submissions): Dockets information at: https://www.gpo.gov/ extension acted with due diligence Management Staff (HFA–305), Food and fdsys/pkg/FR-2015-09-18/pdf/2015- daltland on DSKBBV9HB2PROD with NOTICES during the regulatory review period by Drug Administration, 5630 Fishers 23389.pdf. July 30, 2018. See ‘‘Petitions’’ in the Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to SUPPLEMENTARY INFORMATION section for • For written/paper comments read background documents or the more information. submitted to the Dockets Management electronic and written/paper comments ADDRESSES: You may submit comments Staff, FDA will post your comment, as received, go to https:// as follows. Please note that late, well as any attachments, except for www.regulations.gov and insert the untimely filed comments will not be information submitted, marked and docket number, found in brackets in the VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1

Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices 4219 heading of this document, into the patent’s eligibility for patent term Must be timely (see DATES), must be ‘‘Search’’ box and follow the prompts restoration. In a letter dated May 2, filed in accordance with § 10.20, must and/or go to the Dockets Management 2016, FDA advised the USPTO that this contain sufficient facts to merit an FDA Staff, 5630 Fishers Lane, Rm. 1061, human drug product had undergone a investigation, and must certify that a Rockville, MD 20852. regulatory review period and that the true and complete copy of the petition FOR FURTHER INFORMATION CONTACT: approval of VIEKIRA PAK represented has been served upon the patent Beverly Friedman, Office of Regulatory the first permitted commercial applicant. (See H. Rept. 857, part 1, 98th Policy, Food and Drug Administration, marketing or use of the product. Cong., 2d sess., pp. 41–42, 1984.) 10903 New Hampshire Ave., Bldg. 51, Thereafter, the USPTO requested that Petitions should be in the format Rm. 6250, Silver Spring, MD 20993, FDA determine the product’s regulatory specified in 21 CFR 10.30. 301–796–3600. review period. Submit petitions electronically to SUPPLEMENTARY INFORMATION: https://www.regulations.gov at Docket II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written Period I. Background petitions (two copies are required) to the FDA has determined that the Dockets Management Staff (HFA–305), The Drug Price Competition and applicable regulatory review period for Food and Drug Administration, 5630 Patent Term Restoration Act of 1984 VIEKIRA PAK is 2,391 days. Of this Fishers Lane, Rm. 1061, Rockville, MD (Pub. L. 98–417) and the Generic time, 2,148 days occurred during the 20852. Animal Drug and Patent Term testing phase of the regulatory review Restoration Act (Pub. L. 100–670) Dated: January 24, 2018. period, while 243 days occurred during generally provide that a patent may be Leslie Kux, the approval phase. These periods of extended for a period of up to 5 years Associate Commissioner for Policy. time were derived from the following so long as the patented item (human [FR Doc. 2018–01651 Filed 1–29–18; 8:45 am] dates: drug product, animal drug product, 1. The date an exemption under BILLING CODE 4164–01–P medical device, food additive, or color section 505(i) of the Federal Food, Drug, additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21 review by FDA before the item was U.S.C. 355(i)) became effective: June 4, DEPARTMENT OF HEALTH AND marketed. Under these acts, a product’s 2008. FDA has verified the applicant’s HUMAN SERVICES regulatory review period forms the basis claim that June 4, 2008, is the date the for determining the amount of extension investigational new drug application Food and Drug Administration an applicant may receive. (IND) became effective. [Docket No. FDA–2016–E–2519] A regulatory review period consists of 2. The date the application was two periods of time: A testing phase and initially submitted with respect to the Determination of Regulatory Review an approval phase. For human drug human drug product under section Period for Purposes of Patent products, the testing phase begins when 505(b) of the FD&C Act: April 21, 2014. Extension; UPTRAVI the exemption to permit the clinical FDA has verified the applicant’s claim investigations of the drug becomes AGENCY: Food and Drug Administration, that the new drug application (NDA) for HHS. effective and runs until the approval VIEKIRA PAK (NDA 206619) was phase begins. The approval phase starts initially submitted on April 21, 2014. ACTION: Notice. with the initial submission of an 3. The date the application was SUMMARY: The Food and Drug application to market the human drug approved: December 19, 2014. FDA has Administration (FDA or the Agency) has product and continues until FDA grants verified the applicant’s claim that NDA determined the regulatory review period permission to market the drug product. 206619 was approved on December 19, for UPTRAVI and is publishing this Although only a portion of a regulatory 2014. notice of that determination as required review period may count toward the This determination of the regulatory by law. FDA has made the actual amount of extension that the review period establishes the maximum determination because of the Director of USPTO may award (for potential length of a patent extension. submission of an application to the example, half the testing phase must be However, the USPTO applies several Director of the U.S. Patent and subtracted as well as any time that may statutory limitations in its calculations Trademark Office (USPTO), Department have occurred before the patent was of the actual period for patent extension. of Commerce, for the extension of a issued), FDA’s determination of the In its application for patent extension, patent which claims that human drug length of a regulatory review period for this applicant seeks 93 days of patent product. a human drug product will include all term extension. of the testing phase and approval phase DATES: Anyone with knowledge that any as specified in 35 U.S.C. 156(g)(1)(B). III. Petitions of the dates as published (see the FDA has approved for marketing the Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are human drug product VIEKIRA PAK the dates as published are incorrect may incorrect may submit either electronic (ombitasvir, paritaprevir, dasabuvir, and submit either electronic or written or written comments and ask for a ritonavir). VIEKIRA PAK with or comments and, under 21 CFR 60.24, ask redetermination by April 2, 2018. without ribavirin is indicated for the for a redetermination (see DATES). Furthermore, any interested person may treatment of patients with genotype 1 Furthermore, as specified in § 60.30 (21 petition FDA for a determination chronic hepatitis C virus infection CFR 60.30), any interested person may regarding whether the applicant for daltland on DSKBBV9HB2PROD with NOTICES including those with compensated petition FDA for a determination extension acted with due diligence cirrhosis. Subsequent to this approval, regarding whether the applicant for during the regulatory review period by the USPTO received a patent term extension acted with due diligence July 30, 2018. See ‘‘Petitions’’ in the restoration application for VIEKIRA during the regulatory review period. To SUPPLEMENTARY INFORMATION section for PAK (U.S. Patent No. 8,501,238) from meet its burden, the petition must more information. AbbVie Inc., and the USPTO requested comply with all the requirements of ADDRESSES: You may submit comments FDA’s assistance in determining this § 60.30, including but not limited to: as follows. Please note that late, VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1


Document Created: 2018-10-26 10:10:03
Document Modified: 2018-10-26 10:10:03
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 2, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 30, 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 4218 
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