81_FR_72261 81 FR 72059 - Determination of Regulatory Review Period for Purposes of Patent Extension; REPATHA

81 FR 72059 - Determination of Regulatory Review Period for Purposes of Patent Extension; REPATHA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 202 (October 19, 2016)

Page Range72059-72060
FR Document2016-25221

The Food and Drug Administration (FDA) has determined the regulatory review period for REPATHA 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 202 (Wednesday, October 19, 2016) 
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72059-72060]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-0463; FDA-2016-E-0532; FDA-2016-E-2468]


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

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 REPATHA 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 
December 19, 2016. 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 April 17, 
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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-0463, FDA-2016-E-0532, and FDA-2016-E-2468 for 
``Determination of Regulatory Review Period for Purposes of Patent 
Extension; REPATHA.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://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 http://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 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 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.

[[Page 72060]]

    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 REPATHA 
(evolocumab). REPATHA is indicated as an adjunct to diet and maximally 
tolerated statin therapy for the treatment of adults with heterozygous 
familial hypercholesterolemia or clinical atherosclerotic 
cardiovascular disease, who require additional lowering of low density 
lipoprotein cholesterol (LDL-C) or as an adjunct to diet and other LDL-
lowering therapies for the treatment of patients with homozygous 
familial hypercholesterolemia who require additional lowering of LDL-C. 
Subsequent to this approval, the USPTO received patent term restoration 
applications for REPATHA (U.S. Patent Nos. 8,030,457; 8,829,165; and 
8,981,064) from Amgen Inc., and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated April 29, 2016, FDA advised the USPTO that this human 
biological product had undergone a regulatory review period and that 
the approval of REPATHA 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 
REPATHA is 2,267 days. Of this time, 1,901 days occurred during the 
testing phase of the regulatory review period, while 366 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: June 14, 
2009. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on June 14, 
2009.
    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): August 27, 2014. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
REPATHA (BLA 125522) was initially submitted on August 27, 2014.
    3. The date the application was approved: August 27, 2015. FDA has 
verified the applicant's claim that BLA 125522 was approved on August 
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 895 days, 353 days, or 164 days of patent term 
extension, respectively.

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 http://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: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25221 Filed 10-18-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices 72059 communicate scientific regulatory Electronic Submissions copies total. One copy will include the approaches, in order to prepare for Submit electronic comments in the information you claim to be confidential anticipated high impact emerging following way: with a heading or cover note that states science and technology. Additionally, • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS the Emerging Sciences Working Group www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The informs and advises Agency and FDA instructions for submitting comments. Agency will review this copy, including Center leadership on critical and cross- Comments submitted electronically, the claimed confidential information, in cutting issues likely to impact including attachments, to http:// its consideration of comments. The regulatory policy development. www.regulations.gov will be posted to second copy, which will have the The Emerging Sciences Working the docket unchanged. Because your claimed confidential information Group is seeking input from the public comment will be made public, you are redacted/blacked out, will be available to identify emerging science and solely responsible for ensuring that your for public viewing and posted on http:// technology. Results from long range comment does not include any www.regulations.gov. Submit both horizon scanning will assist FDA confidential information that you or a copies to the Division of Dockets regarding emerging issues and cross- third party may not wish to be posted, Management. If you do not wish your cutting scientific advances, which may such as medical information, your or name and contact information to be impact FDA preparedness in the future. anyone else’s Social Security number, or made publicly available, you can Dated: October 13, 2016. confidential business information, such provide this information on the cover Leslie Kux, as a manufacturing process. Please note sheet and not in the body of your that if you include your name, contact comments and you must identify this Associate Commissioner for Policy. information, or other information that information as ‘‘confidential.’’ Any [FR Doc. 2016–25223 Filed 10–18–16; 8:45 am] identifies you in the body of your information marked as ‘‘confidential’’ BILLING CODE 4164–01–P will not be disclosed except in comments, that information will be posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other • If you want to submit a comment applicable disclosure law. For more DEPARTMENT OF HEALTH AND with confidential information that you information about FDA’s posting of HUMAN SERVICES do not wish to be made available to the comments to public dockets, see 80 FR Food and Drug Administration public, submit the comment as a 56469, September 18, 2015, or access written/paper submission and in the the information at: http://www.fda.gov/ manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ [Docket Nos. FDA–2016–E–0463; FDA– Submissions’’ and ‘‘Instructions’’). default.htm. 2016–E–0532; FDA–2016–E–2468] Docket: For access to the docket to Determination of Regulatory Review Written/Paper Submissions read background documents or the Period for Purposes of Patent Submit written/paper submissions as electronic and written/paper comments Extension; REPATHA follows: received, go to http:// • Mail/Hand delivery/Courier (for www.regulations.gov and insert the AGENCY: Food and Drug Administration, written/paper submissions): Division of docket number, found in brackets in the HHS. Dockets Management (HFA–305), Food heading of this document, into the ACTION: Notice. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets SUMMARY: The Food and Drug • For written/paper comments Management, 5630 Fishers Lane, Rm. Administration (FDA) has determined submitted to the Division of Dockets 1061, Rockville, MD 20852. the regulatory review period for Management, FDA will post your REPATHA and is publishing this notice FOR FURTHER INFORMATION CONTACT: comment, as well as any attachments, Beverly Friedman, Office of Regulatory of that determination as required by except for information submitted, law. FDA has made the determination Policy, Food and Drug Administration, marked and identified, as confidential, 10903 New Hampshire Ave., Bldg. 51, because of the submission of if submitted as detailed in applications to the Director of the U.S. Rm. 6250, Silver Spring, MD 20993, ‘‘Instructions.’’ 301–796–3600. Patent and Trademark Office (USPTO), Instructions: All submissions received Department of Commerce, for the must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION: extension of a patent which claims that 2016–E–0463, FDA–2016–E–0532, and human biological product. I. Background FDA–2016–E–2468 for ‘‘Determination DATES: Anyone with knowledge that any of Regulatory Review Period for The Drug Price Competition and of the dates as published (see the Purposes of Patent Extension; Patent Term Restoration Act of 1984 SUPPLEMENTARY INFORMATION section) are REPATHA.’’ Received comments will be (Pub. L. 98–417) and the Generic incorrect may submit either electronic placed in the docket and, except for Animal Drug and Patent Term or written comments and ask for a those submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670) redetermination by December 19, 2016. Submissions,’’ publicly viewable at generally provide that a patent may be Furthermore, any interested person may http://www.regulations.gov or at the extended for a period of up to 5 years petition FDA for a determination Division of Dockets Management so long as the patented item (human regarding whether the applicant for between 9 a.m. and 4 p.m., Monday drug product, animal drug product, sradovich on DSK3GMQ082PROD with NOTICES extension acted with due diligence through Friday. medical device, food additive, or color during the regulatory review period by • Confidential Submissions—To additive) was subject to regulatory April 17, 2017. See ‘‘Petitions’’ in the submit a comment with confidential review by FDA before the item was SUPPLEMENTARY INFORMATION section for information that you do not wish to be marketed. Under these acts, a product’s more information. made publicly available, submit your regulatory review period forms the basis ADDRESSES: You may submit comments comments only as a written/paper for determining the amount of extension as follows: submission. You should submit two an applicant may receive. VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1

72060 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices A regulatory review period consists of 1. The date an exemption under DEPARTMENT OF HEALTH AND two periods of time: A testing phase and section 505(i) of the Federal Food, Drug, HUMAN SERVICES an approval phase. For human and Cosmetic Act (21 U.S.C. 355(i)) biological products, the testing phase became effective: June 14, 2009. FDA Food and Drug Administration begins when the exemption to permit has verified the applicant’s claim that [Docket No. FDA–2004–E–0463] the clinical investigations of the the date the investigational new drug biological becomes effective and runs application became effective was on Determination of Regulatory Review until the approval phase begins. The June 14, 2009. Period for Purposes of Patent approval phase starts with the initial Extension; PRILOSEC OTC submission of an application to market 2. The date the application was the human biological product and initially submitted with respect to the AGENCY: Food and Drug Administration, continues until FDA grants permission human biological product under section HHS. to market the biological product. 351 of the Public Health Service Act (42 ACTION: Notice. Although only a portion of a regulatory U.S.C. 262): August 27, 2014. FDA has review period may count toward the verified the applicant’s claim that the SUMMARY: The Food and Drug actual amount of extension that the biologics license application (BLA) for Administration (FDA) has determined Director of USPTO may award (for REPATHA (BLA 125522) was initially the regulatory review period for example, half the testing phase must be submitted on August 27, 2014. PRILOSEC OTC and is publishing this subtracted as well as any time that may notice of that determination as required 3. The date the application was have occurred before the patent was by law. FDA has made the approved: August 27, 2015. FDA has determination because of the issued), FDA’s determination of the verified the applicant’s claim that BLA submission of an application to the length of a regulatory review period for a human biological product will include 125522 was approved on August 27, Director of the U.S. Patent and all of the testing phase and approval 2015. Trademark Office (USPTO), Department phase as specified in 35 U.S.C. This determination of the regulatory of Commerce, for the extension of a 156(g)(1)(B). review period establishes the maximum patent which claims that human drug FDA has approved for marketing the potential length of a patent extension. product. human biologic product REPATHA However, the USPTO applies several DATES: Anyone with knowledge that any (evolocumab). REPATHA is indicated as statutory limitations in its calculations of the dates as published (see the an adjunct to diet and maximally of the actual period for patent extension. SUPPLEMENTARY INFORMATION section) are tolerated statin therapy for the treatment In its applications for patent extension, incorrect may submit either electronic of adults with heterozygous familial this applicant seeks 895 days, 353 days, or written comments and ask for a hypercholesterolemia or clinical or 164 days of patent term extension, redetermination by December 19, 2016. atherosclerotic cardiovascular disease, respectively. Furthermore, any interested person may who require additional lowering of low petition FDA for a determination density lipoprotein cholesterol (LDL–C) III. Petitions regarding whether the applicant for or as an adjunct to diet and other LDL- Anyone with knowledge that any of extension acted with due diligence lowering therapies for the treatment of the dates as published are incorrect may during the regulatory review period by patients with homozygous familial hypercholesterolemia who require submit either electronic or written April 17, 2017. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for additional lowering of LDL–C. comments and ask for a redetermination Subsequent to this approval, the USPTO more information. (see DATES). Furthermore, any interested received patent term restoration person may petition FDA for a ADDRESSES: You may submit comments applications for REPATHA (U.S. Patent determination regarding whether the as follows: Nos. 8,030,457; 8,829,165; and applicant for extension acted with due Electronic Submissions 8,981,064) from Amgen Inc., and the diligence during the regulatory review USPTO requested FDA’s assistance in Submit electronic comments in the period. To meet its burden, the petition determining the patents’ eligibility for following way: must be timely (see DATES) and contain • Federal eRulemaking Portal: http:// patent term restoration. In a letter dated sufficient facts to merit an FDA April 29, 2016, FDA advised the USPTO www.regulations.gov. Follow the investigation. (See H. Rept. 857, part 1, instructions for submitting comments. that this human biological product had 98th Cong., 2d sess., pp. 41–42, 1984.) Comments submitted electronically, undergone a regulatory review period Petitions should be in the format including attachments, to http:// and that the approval of REPATHA represented the first permitted specified in 21 CFR 10.30. www.regulations.gov will be posted to commercial marketing or use of the Submit petitions electronically to the docket unchanged. Because your product. Thereafter, the USPTO http://www.regulations.gov at Docket comment will be made public, you are requested that FDA determine the No. FDA–2013–S–0610. Submit written solely responsible for ensuring that your product’s regulatory review period. petitions (two copies are required) to the comment does not include any Division of Dockets Management (HFA– confidential information that you or a II. Determination of Regulatory Review third party may not wish to be posted, Period 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, such as medical information, your or FDA has determined that the anyone else’s Social Security number, or sradovich on DSK3GMQ082PROD with NOTICES MD 20852. applicable regulatory review period for confidential business information, such REPATHA is 2,267 days. Of this time, Dated: October 13, 2016. as a manufacturing process. Please note 1,901 days occurred during the testing Leslie Kux, that if you include your name, contact phase of the regulatory review period, Associate Commissioner for Policy. information, or other information that while 366 days occurred during the [FR Doc. 2016–25221 Filed 10–18–16; 8:45 am] identifies you in the body of your approval phase. These periods of time BILLING CODE 4164–01–P comments, that information will be were derived from the following dates: posted on http://www.regulations.gov. VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1


Document Created: 2016-10-19 02:12:02
Document Modified: 2016-10-19 02:12:02
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 December 19, 2016. 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 April 17, 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 72059 
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