82_FR_2385 82 FR 2380 - Determination of Regulatory Review Period for Purposes of Patent Extension; EMPLICITI

82 FR 2380 - Determination of Regulatory Review Period for Purposes of Patent Extension; EMPLICITI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 5 (January 9, 2017)

Page Range2380-2381
FR Document2017-00108

The Food and Drug Administration (FDA) has determined the regulatory review period for EMPLICITI 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 biological product.

Federal Register, Volume 82 Issue 5 (Monday, January 9, 2017) 
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2380-2381]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1198]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for EMPLICITI 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 biological 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 March 
10, 2017. 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 10, 2017. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-1198 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; EMPLICITI.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management 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 Division of Dockets Management. 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 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

[[Page 2381]]

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 Division of Dockets Management, 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 
biological 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 biologic product EMPLICITI 
(elotuzumab). EMPLICITI is indicated in combination with lenalidomide 
and dexamethasone for the treatment of patients with multiple myeloma 
who have received one to three prior therapies. Subsequent to this 
approval, the USPTO received a patent term restoration application for 
EMPLICITI (U.S. Patent No. 7,709,610) from AbbVie Biotherapeutics, 
Inc., and the USPTO requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
July 12, 2016, FDA advised the USPTO that this human biological product 
had undergone a regulatory review period and that the approval of 
EMPLICITI 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 
EMPLICITI is 3,400 days. Of this time, 3,245 days occurred during the 
testing phase of the regulatory review period, while 155 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 (21 U.S.C. 355(i)) became effective: August 11, 
2006. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on August 11, 
2006.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): June 29, 2015. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
EMPLICITI (BLA 761035) was initially submitted on June 29, 2015.
    3. The date the application was approved: November 30, 2015. FDA 
has verified the applicant's claim that BLA 761035 was approved on 
November 30, 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 application for patent extension, 
this applicant seeks 1,095 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 ask for 
a redetermination (see DATES). 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. 
To meet its burden, the petition must be timely (see DATES) and contain 
sufficient facts to merit an FDA investigation. (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 Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00108 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-P

2380 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices time were derived from the following DEPARTMENT OF HEALTH AND do not wish to be made available to the dates: HUMAN SERVICES public, submit the comment as a 1. The date an exemption under written/paper submission and in the Food and Drug Administration manner detailed (see ‘‘Written/Paper section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) [Docket No. FDA–2016–E–1198] Submissions’’ and ‘‘Instructions’’). became effective: December 19, 2012. Written/Paper Submissions FDA has verified the applicant’s claim Determination of Regulatory Review Period for Purposes of Patent Submit written/paper submissions as that the date the investigational new follows: drug application became effective was Extension; EMPLICITI • Mail/Hand delivery/Courier (for on December 19, 2012. AGENCY: Food and Drug Administration, written/paper submissions): Division of 2. The date the application was HHS. Dockets Management (HFA–305), Food initially submitted with respect to the ACTION: Notice. and Drug Administration, 5630 Fishers human biological product under section Lane, Rm. 1061, Rockville, MD 20852. 351 of the Public Health Service Act (42 SUMMARY: The Food and Drug • For written/paper comments U.S.C. 262): November 25, 2014. FDA Administration (FDA) has determined submitted to the Division of Dockets has verified the applicant’s claim that the regulatory review period for Management, FDA will post your EMPLICITI and is publishing this notice comment, as well as any attachments, the biologics license application (BLA) of that determination as required by except for information submitted, for ADYNOVATE (BLA 125566) was law. FDA has made the determination marked and identified, as confidential, initially submitted on November 25, because of the submission of an if submitted as detailed in 2014. application to the Director of the U.S. ‘‘Instructions.’’ 3. The date the application was Patent and Trademark Office (USPTO), Instructions: All submissions received approved: November 13, 2015. FDA has Department of Commerce, for the must include the Docket No. FDA– verified the applicant’s claim that BLA extension of a patent which claims that 2016–E–1198 for ‘‘Determination of 125566 was approved on November 13, human biological product. Regulatory Review Period for Purposes 2015. DATES: Anyone with knowledge that any of Patent Extension; EMPLICITI.’’ This determination of the regulatory of the dates as published (see the Received comments will be placed in review period establishes the maximum SUPPLEMENTARY INFORMATION section) are the docket and, except for those potential length of a patent extension. incorrect may submit either electronic submitted as ‘‘Confidential However, the USPTO applies several or written comments and ask for a Submissions,’’ publicly viewable at statutory limitations in its calculations redetermination by March 10, 2017. https://www.regulations.gov or at the of the actual period for patent extension. Furthermore, any interested person may Division of Dockets Management In its application for patent extension, petition FDA for a determination between 9 a.m. and 4 p.m., Monday this applicant seeks 708 days of patent regarding whether the applicant for through Friday. term extension. extension acted with due diligence • Confidential Submissions—To during the regulatory review period by submit a comment with confidential III. Petitions July 10, 2017. See ‘‘Petitions’’ in the information that you do not wish to be SUPPLEMENTARY INFORMATION section for made publicly available, submit your Anyone with knowledge that any of comments only as a written/paper the dates as published are incorrect may more information. ADDRESSES: You may submit comments submission. You should submit two submit either electronic or written copies total. One copy will include the comments and ask for a redetermination as follows: information you claim to be confidential (see DATES). Furthermore, any interested Electronic Submissions with a heading or cover note that states person may petition FDA for a ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the determination regarding whether the CONFIDENTIAL INFORMATION.’’ The following way: applicant for extension acted with due • Federal eRulemaking Portal: Agency will review this copy, including diligence during the regulatory review https://www.regulations.gov. Follow the the claimed confidential information, in period. To meet its burden, the petition instructions for submitting comments. its consideration of comments. The must be timely (see DATES) and contain Comments submitted electronically, second copy, which will have the sufficient facts to merit an FDA including attachments, to https:// claimed confidential information investigation. (See H. Rept. 857, part 1, www.regulations.gov will be posted to redacted/blacked out, will be available 98th Cong., 2d sess., pp. 41–42, 1984.) the docket unchanged. Because your for public viewing and posted on Petitions should be in the format comment will be made public, you are https://www.regulations.gov. Submit specified in 21 CFR 10.30. solely responsible for ensuring that your both copies to the Division of Dockets Submit petitions electronically to comment does not include any Management. If you do not wish your https://www.regulations.gov at Docket confidential information that you or a name and contact information to be No. FDA–2013–S–0610. Submit written third party may not wish to be posted, made publicly available, you can petitions (two copies are required) to the such as medical information, your or provide this information on the cover Division of Dockets Management (HFA– anyone else’s Social Security number, or sheet and not in the body of your 305), Food and Drug Administration, confidential business information, such comments and you must identify this 5630 Fishers Lane, Rm. 1061, Rockville, information as ‘‘confidential.’’ Any sradovich on DSK3GMQ082PROD with NOTICES as a manufacturing process. Please note MD 20852. that if you include your name, contact information marked as ‘‘confidential’’ Dated: January 3, 2017. information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other Leslie Kux, comments, that information will be applicable disclosure law. For more Associate Commissioner for Policy. posted on https://www.regulations.gov. information about FDA’s posting of [FR Doc. 2017–00095 Filed 1–6–17; 8:45 am] • If you want to submit a comment comments to public dockets, see 80 FR BILLING CODE 4164–01–P with confidential information that you 56469, September 18, 2015, or access VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1

Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2381 the information at: http://www.fda.gov/ combination with lenalidomide and (see DATES). Furthermore, any interested regulatoryinformation/dockets/ dexamethasone for the treatment of person may petition FDA for a default.htm. patients with multiple myeloma who determination regarding whether the Docket: For access to the docket to have received one to three prior applicant for extension acted with due read background documents or the therapies. Subsequent to this approval, diligence during the regulatory review electronic and written/paper comments the USPTO received a patent term period. To meet its burden, the petition received, go to https:// restoration application for EMPLICITI must be timely (see DATES) and contain www.regulations.gov and insert the (U.S. Patent No. 7,709,610) from AbbVie sufficient facts to merit an FDA docket number, found in brackets in the Biotherapeutics, Inc., and the USPTO investigation. (See H. Rept. 857, part 1, heading of this document, into the requested FDA’s assistance in 98th Cong., 2d sess., pp. 41–42, 1984.) ‘‘Search’’ box and follow the prompts determining this patent’s eligibility for Petitions should be in the format and/or go to the Division of Dockets patent term restoration. In a letter dated specified in 21 CFR 10.30. Management, 5630 Fishers Lane, Rm. July 12, 2016, FDA advised the USPTO Submit petitions electronically to 1061, Rockville, MD 20852. that this human biological product had https://www.regulations.gov at Docket FOR FURTHER INFORMATION CONTACT: undergone a regulatory review period No. FDA–2013–S–0610. Submit written Beverly Friedman, Office of Regulatory and that the approval of EMPLICITI petitions (two copies are required) to the Policy, Food and Drug Administration, represented the first permitted Division of Dockets Management (HFA– 10903 New Hampshire Ave., Bldg. 51, commercial marketing or use of the 305), Food and Drug Administration, Rm. 6250, Silver Spring, MD 20993, product. Thereafter, the USPTO 5630 Fishers Lane, Rm. 1061, Rockville, 301–796–3600. requested that FDA determine the MD 20852. SUPPLEMENTARY INFORMATION: product’s regulatory review period. Dated: December 30, 2016. I. Background II. Determination of Regulatory Review Leslie Kux, Period Associate Commissioner for Policy. The Drug Price Competition and FDA has determined that the [FR Doc. 2017–00108 Filed 1–6–17; 8:45 am] Patent Term Restoration Act of 1984 applicable regulatory review period for BILLING CODE 4164–01–P (Pub. L. 98–417) and the Generic EMPLICITI is 3,400 days. Of this time, Animal Drug and Patent Term 3,245 days occurred during the testing Restoration Act (Pub. L. 100–670) DEPARTMENT OF HEALTH AND phase of the regulatory review period, generally provide that a patent may be HUMAN SERVICES while 155 days occurred during the extended for a period of up to 5 years approval phase. These periods of time so long as the patented item (human Food and Drug Administration were derived from the following dates: drug product, animal drug product, 1. The date an exemption under medical device, food additive, or color section 505(i) of the Federal Food, Drug, [Docket No. FDA–2016–N–4508] additive) was subject to regulatory and Cosmetic Act (21 U.S.C. 355(i)) review by FDA before the item was became effective: August 11, 2006. FDA Generic Drug User Fee Amendments II marketed. Under these acts, a product’s has verified the applicant’s claim that Program Fee: List of Abbreviated New regulatory review period forms the basis the date the investigational new drug Drug Application Sponsors and for determining the amount of extension application became effective was on Application Numbers; Request for an applicant may receive. August 11, 2006. Information and Comments A regulatory review period consists of 2. The date the application was two periods of time: A testing phase and AGENCY: Food and Drug Administration, initially submitted with respect to the HHS. an approval phase. For human human biological product under section biological products, the testing phase ACTION:Notice; request for information 351 of the Public Health Service Act (42 begins when the exemption to permit and comments. U.S.C. 262): June 29, 2015. FDA has the clinical investigations of the verified the applicant’s claim that the biological becomes effective and runs SUMMARY: The Food and Drug biologics license application (BLA) for Administration (FDA) is seeking until the approval phase begins. The EMPLICITI (BLA 761035) was initially approval phase starts with the initial information and public comment, in submitted on June 29, 2015. anticipation of the passage of Generic submission of an application to market 3. The date the application was the human biological product and Drug User Fee Amendments approved: November 30, 2015. FDA has reauthorization (GDUFA II), relevant to continues until FDA grants permission verified the applicant’s claim that BLA to market the biological product. FDA’s planned approach for 761035 was approved on November 30, administering generic drug program fees Although only a portion of a regulatory 2015. review period may count toward the under that legislation for fiscal year (FY) This determination of the regulatory 2018. This includes requests for actual amount of extension that the review period establishes the maximum Director of USPTO may award (for comment and information regarding potential length of a patent extension. FDA’s initial inventory of approved example, half the testing phase must be However, the USPTO applies several subtracted as well as any time that may abbreviated new drug application statutory limitations in its calculations sponsors and application numbers. The have occurred before the patent was of the actual period for patent extension. issued), FDA’s determination of the information gathered from public In its application for patent extension, comments will assist FDA in accurately length of a regulatory review period for sradovich on DSK3GMQ082PROD with NOTICES this applicant seeks 1,095 days of patent assessing FY 2018 GDUFA program fees a human biological product will include term extension. all of the testing phase and approval in a timely manner. phase as specified in 35 U.S.C. III. Petitions DATES: Submit written or electronic 156(g)(1)(B). Anyone with knowledge that any of comments and information by March FDA has approved for marketing the the dates as published are incorrect may 10, 2017. human biologic product EMPLICITI submit either electronic or written ADDRESSES: You may submit comments (elotuzumab). EMPLICITI is indicated in comments and ask for a redetermination as follows: VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1


Document Created: 2018-10-24 11:10:02
Document Modified: 2018-10-24 11:10:02
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 March 10, 2017. 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 10, 2017. 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 Citation82 FR 2380 
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