81_FR_87801 81 FR 87568 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEXSERO

81 FR 87568 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEXSERO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 233 (December 5, 2016)

Page Range87568-87569
FR Document2016-29025

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

Federal Register, Volume 81 Issue 233 (Monday, December 5, 2016) 
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87568-87569]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-0617; FDA-2016-E-0619]


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

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 BEXSERO 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 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 
February 3, 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 June 5, 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 Nos. 
FDA-2016-E-0617 and FDA-2016-E-0619 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; BEXSERO.'' 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 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 product 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

[[Page 87569]]

(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 BEXSERO 
(Meningococcal Group B vaccine). BEXSERO is indicated for active 
immunization to prevent invasive disease caused by Neisseria 
meningitidis serogroup B and is approved for use in individuals 10 
through 25 years of age. Subsequent to this approval, the USPTO 
received patent term restoration applications for BEXSERO (U.S. Patent 
Nos. 8,273,360 and 8,663,656) from GlaxoSmithKline Biologicals SA, and 
the USPTO requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated April 20, 
2016, FDA advised the USPTO that this human biological product had 
undergone a regulatory review period and that the approval of BEXSERO 
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 
BEXSERO is 3,963 days. Of this time, 3,779 days occurred during the 
testing phase of the regulatory review period, while 184 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: March 20, 
2004. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on March 20, 
2004.
    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): July 24, 2014. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
BEXSERO (BLA 125546/0) was initially submitted on July 24, 2014.
    3. The date the application was approved: January 23, 2015. FDA has 
verified the applicant's claim that BLA 125546/0 was approved on 
January 23, 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 518 days or 255 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: November 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29025 Filed 12-2-16; 8:45 am]
BILLING CODE 4164-01-P

87568 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices GuidanceComplianceEnforcement/ third party may not wish to be posted, made publicly available, you can GuidanceforIndustry/default.htm or such as medical information, your or provide this information on the cover http://www.regulations.gov. anyone else’s Social Security number, or sheet and not in the body of your Dated: November 18, 2016. confidential business information, such comments and you must identify this Leslie Kux, as a manufacturing process. Please note information as ‘‘confidential.’’ Any that if you include your name, contact information marked as ‘‘confidential’’ Associate Commissioner for Policy. information, or other information that will not be disclosed except in [FR Doc. 2016–29133 Filed 12–2–16; 8:45 am] identifies you in the body of your accordance with 21 CFR 10.20 and other BILLING CODE 4164–01–P comments, that information will be applicable disclosure law. For more posted on https://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR DEPARTMENT OF HEALTH AND with confidential information that you 56469, September 18, 2015, or access HUMAN SERVICES do not wish to be made available to the the information at: http://www.fda.gov/ public, submit the comment as a regulatoryinformation/dockets/ Food and Drug Administration written/paper submission and in the default.htm. [Docket Nos. FDA–2016–E–0617; FDA– manner detailed (see ‘‘Written/Paper Docket: For access to the docket to 2016–E–0619] Submissions’’ and ‘‘Instructions’’). read background documents or the Written/Paper Submissions electronic and written/paper comments Determination of Regulatory Review received, go to https:// Period for Purposes of Patent Submit written/paper submissions as www.regulations.gov and insert the Extension; BEXSERO follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for AGENCY: Food and Drug Administration, heading of this document, into the written/paper submissions): Division of HHS. ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food ACTION: Notice. and/or go to the Division of Dockets and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. SUMMARY: The Food and Drug • For written/paper comments 1061, Rockville, MD 20852. Administration (FDA) has determined submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: the regulatory review period for Management, FDA will post your Beverly Friedman, Office of Regulatory BEXSERO and is publishing this notice comment, as well as any attachments, Policy, Food and Drug Administration, of that determination as required by except for information submitted, 10903 New Hampshire Ave., Bldg. 51, law. FDA has made the determination marked and identified, as confidential, Rm. 6250, Silver Spring, MD 20993, because of the submission of if submitted as detailed in 301–796–3600. applications to the Director of the U.S. ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Patent and Trademark Office (USPTO), Instructions: All submissions received Department of Commerce, for the must include the Docket Nos. FDA– I. Background extension of a patent which claims that 2016–E–0617 and FDA–2016–E–0619 The Drug Price Competition and human biological product. for ‘‘Determination of Regulatory Patent Term Restoration Act of 1984 DATES: Anyone with knowledge that any Review Period for Purposes of Patent (Pub. L. 98–417) and the Generic of the dates as published (see the Extension; BEXSERO.’’ Received Animal Drug and Patent Term SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket Restoration Act (Pub. L. 100–670) incorrect may submit either electronic and, except for those submitted as generally provide that a patent may be or written comments and ask for a ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years redetermination by February 3, 2017. viewable at https://www.regulations.gov so long as the patented item (human Furthermore, any interested person may or at the Division of Dockets drug product, animal drug product, petition FDA for a determination Management between 9 a.m. and 4 p.m., medical device, food additive, or color regarding whether the applicant for Monday through Friday. additive) was subject to regulatory extension acted with due diligence • Confidential Submissions—To review by FDA before the item was during the regulatory review period by submit a comment with confidential marketed. Under these acts, a product’s June 5, 2017. See ‘‘Petitions’’ in the information that you do not wish to be regulatory review period forms the basis SUPPLEMENTARY INFORMATION section for made publicly available, submit your for determining the amount of extension more information. comments only as a written/paper an applicant may receive. ADDRESSES: You may submit comments submission. You should submit two A regulatory review period consists of as follows: copies total. One copy will include the two periods of time: A testing phase and information you claim to be confidential an approval phase. For human Electronic Submissions with a heading or cover note that states biological products, the testing phase Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit following way: CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the • Federal eRulemaking Portal: Agency will review this copy, including biological product becomes effective https://www.regulations.gov. Follow the the claimed confidential information, in and runs until the approval phase instructions for submitting comments. its consideration of comments. The begins. The approval phase starts with Comments submitted electronically, second copy, which will have the the initial submission of an application sradovich on DSK3GMQ082PROD with NOTICES including attachments, to https:// claimed confidential information to market the human biological product www.regulations.gov will be posted to redacted/blacked out, will be available and continues until FDA grants the docket unchanged. Because your for public viewing and posted on permission to market the biological comment will be made public, you are https://www.regulations.gov. Submit product. Although only a portion of a solely responsible for ensuring that your both copies to the Division of Dockets regulatory review period may count comment does not include any Management. If you do not wish your toward the actual amount of extension confidential information that you or a name and contact information to be that the Director of USPTO may award VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1

Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 87569 (for example, half the testing phase must This determination of the regulatory ‘‘General Principles for Evaluating the be subtracted as well as any time that review period establishes the maximum Abuse Deterrence of Generic Solid Oral may have occurred before the patent potential length of a patent extension. Opioid Drug Products’’ and FDA’s was issued), FDA’s determination of the However, the USPTO applies several efforts to develop standardized in vitro length of a regulatory review period for statutory limitations in its calculations testing methodologies for evaluating the a human biological product will include of the actual period for patent extension. abuse deterrence of opioid drug all of the testing phase and approval In its applications for patent extension, products. We are taking this action in phase as specified in 35 U.S.C. this applicant seeks 518 days or 255 response to requests for an extension to 156(g)(1)(B). days of patent term extension. allow interested persons additional time FDA has approved for marketing the III. Petitions to submit comments. human biologic product BEXSERO DATES: FDA is extending the comment (Meningococcal Group B vaccine). Anyone with knowledge that any of period on the Public Meeting on Pre- BEXSERO is indicated for active the dates as published are incorrect may Market Evaluation of Abuse-Deterrent immunization to prevent invasive submit either electronic or written Properties of Opioid Drug Products disease caused by Neisseria comments and ask for a redetermination published October 6, 2016 (81 FR meningitidis serogroup B and is (see DATES). Furthermore, any interested 69532). Submit either electronic or approved for use in individuals 10 person may petition FDA for a written comments by January 3, 2017. through 25 years of age. Subsequent to determination regarding whether the applicant for extension acted with due ADDRESSES: You may submit comments this approval, the USPTO received as follows: patent term restoration applications for diligence during the regulatory review BEXSERO (U.S. Patent Nos. 8,273,360 period. To meet its burden, the petition Electronic Submissions and 8,663,656) from GlaxoSmithKline must be timely (see DATES) and contain sufficient facts to merit an FDA Submit electronic comments in the Biologicals SA, and the USPTO following way: investigation. (See H. Rept. 857, part 1, requested FDA’s assistance in • Federal eRulemaking Portal: 98th Cong., 2d sess., pp. 41–42, 1984.) determining the patents’ eligibility for https://www.regulations.gov. Follow the Petitions should be in the format patent term restoration. In a letter dated instructions for submitting comments. specified in 21 CFR 10.30. April 20, 2016, FDA advised the USPTO Submit petitions electronically to Comments submitted electronically, that this human biological product had https://www.regulations.gov at Docket including attachments, to https:// undergone a regulatory review period No. FDA–2013–S–0610. Submit written www.regulations.gov will be posted to and that the approval of BEXSERO petitions (two copies are required) to the the docket unchanged. Because your represented the first permitted Division of Dockets Management (HFA– comment will be made public, you are commercial marketing or use of the 305), Food and Drug Administration, solely responsible for ensuring that your product. Thereafter, the USPTO 5630 Fishers Lane, Rm. 1061, Rockville, comment does not include any requested that FDA determine the MD 20852. confidential information that you or a product’s regulatory review period. third party may not wish to be posted, Dated: November 28, 2016. II. Determination of Regulatory Review such as medical information, your or Leslie Kux, Period anyone else’s Social Security number, or Associate Commissioner for Policy. confidential business information, such FDA has determined that the [FR Doc. 2016–29025 Filed 12–2–16; 8:45 am] as a manufacturing process. Please note applicable regulatory review period for BILLING CODE 4164–01–P that if you include your name, contact BEXSERO is 3,963 days. Of this time, information, or other information that 3,779 days occurred during the testing identifies you in the body of your phase of the regulatory review period, DEPARTMENT OF HEALTH AND comments, that information will be while 184 days occurred during the HUMAN SERVICES posted on https://www.regulations.gov. approval phase. These periods of time • If you want to submit a comment were derived from the following dates: Food and Drug Administration with confidential information that you 1. The date an exemption under [Docket No. FDA–2016–N–2896] do not wish to be made available to the section 505(i) of the Federal Food, Drug, public, submit the comment as a and Cosmetic Act (21 U.S.C. 355(i)) Public Meeting on Pre-Market written/paper submission and in the became effective: March 20, 2004. FDA Evaluation of Abuse-Deterrent manner detailed (see ‘‘Written/Paper has verified the applicant’s claim that Properties of Opioid Drug Products; Submissions’’ and ‘‘Instructions’’). the date the investigational new drug Extension of Comment Period application became effective was on Written/Paper Submissions AGENCY: Food and Drug Administration, March 20, 2004. HHS. Submit written/paper submissions as 2. The date the application was ACTION: Notice of public meeting; follows: initially submitted with respect to the extension of comment period. • Mail/Hand delivery/Courier (for human biological product under section written/paper submissions): Division of 351 of the Public Health Service Act (42 SUMMARY: The Food and Drug Dockets Management (HFA–305), Food U.S.C. 262): July 24, 2014. FDA has Administration (FDA or we) is and Drug Administration, 5630 Fishers verified the applicant’s claim that the extending the comment period for the Lane, Rm. 1061, Rockville, MD 20852. biologics license application (BLA) for public meeting on Pre-Market • For written/paper comments sradovich on DSK3GMQ082PROD with NOTICES BEXSERO (BLA 125546/0) was initially Evaluation of Abuse-Deterrent submitted to the Division of Dockets submitted on July 24, 2014. Properties of Opioid Drug Products that Management, FDA will post your 3. The date the application was was announced in the Federal Register comment, as well as any attachments, approved: January 23, 2015. FDA has on October 6, 2016. In that Federal except for information submitted, verified the applicant’s claim that BLA Register notice, FDA requested marked and identified, as confidential, 125546/0 was approved on January 23, comments on the approach to testing if submitted as detailed in 2015. FDA recommended in its draft guidance ‘‘Instructions.’’ VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1


Document Created: 2016-12-03 00:26:18
Document Modified: 2016-12-03 00:26:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 3, 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 June 5, 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 Citation81 FR 87568 
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