81_FR_65840 81 FR 65655 - Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA

81 FR 65655 - Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 185 (September 23, 2016)

Page Range65655-65656
FR Document2016-22933

The Food and Drug Administration (FDA) has determined the regulatory review period for FYCOMPA 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 81 Issue 185 (Friday, September 23, 2016) 
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65655-65656]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0072]


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

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 FYCOMPA 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 
November 22, 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 March 22, 
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 No. 
FDA-2014-E-0072 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; FYCOMPA.'' 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.
    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

[[Page 65656]]

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 FYCOMPA 
(perampanel). FYCOMPA is indicated as adjunctive therapy for the 
treatment of partial-onset seizures with or without secondarily 
generalized seizures in patients with epilepsy aged 12 years and older. 
Subsequent to this approval, the USPTO received a patent term 
restoration application for FYCOMPA (U.S. Patent No. 6,949,571) from 
Eisai R&D Management Co., Ltd., and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 26, 2014, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of FYCOMPA 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 
FYCOMPA is 3,274 days. Of this time, 2,968 days occurred during the 
testing phase of the regulatory review period, while 306 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: November 7, 2003. FDA has verified the Eisai R&D Management 
Co., Ltd. claim that November 7, 2003, is the date the investigational 
new drug application 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: December 
22, 2011. The applicant claims May 25, 2011, as the date that the new 
drug application (NDA) for Fycompa (NDA 202834) was initially 
submitted. However, FDA records indicate that NDA 202834, received May 
25, 2011, was not sufficiently complete to permit a substantive review. 
FDA refused to file this application and notified the applicant of this 
fact by letter dated July 21, 2011. The completed NDA was then 
submitted on December 22, 2011, which is considered to be the date that 
the NDA was initially submitted within the meaning of 35 U.S.C. 
156(g)(B)(ii).
    3. The date the application was approved: October 22, 2012. FDA has 
verified the applicant's claim that NDA 202834 was approved on October 
22, 2012.
    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 1,549 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 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: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22933 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices 65655 www.fda.gov/RegulatoryInformation/ such as medical information, your or provide this information on the cover Guidances/ucm122045.htm or http:// anyone else’s Social Security number, or sheet and not in the body of your www.regulations.gov. confidential business information, such comments and you must identify this Dated: September 19, 2016. as a manufacturing process. Please note information as ‘‘confidential.’’ Any Leslie Kux, that if you include your name, contact information marked as ‘‘confidential’’ information, or other information that will not be disclosed except in Associate Commissioner for Policy. identifies you in the body of your accordance with 21 CFR 10.20 and other [FR Doc. 2016–22936 Filed 9–22–16; 8:45 am] comments, that information will be applicable disclosure law. For more BILLING CODE 4164–01–P posted on http://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/ HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/ written/paper submission and in the default.htm. Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to [Docket No. FDA–2014–E–0072] Submissions’’ and ‘‘Instructions’’). read background documents or the Written/Paper Submissions electronic and written/paper comments Determination of Regulatory Review received, go to http:// Period for Purposes of Patent Submit written/paper submissions as www.regulations.gov and insert the Extension; FYCOMPA 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 FYCOMPA 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 an if submitted as detailed in 301–796–3600. application 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 No. FDA– I. Background extension of a patent which claims that 2014–E–0072 for ‘‘Determination of The Drug Price Competition and human drug product. Regulatory Review Period for Purposes Patent Term Restoration Act of 1984 DATES: Anyone with knowledge that any of Patent Extension; FYCOMPA.’’ (Pub. L. 98–417) and the Generic of the dates as published (in the Received comments will be placed in Animal Drug and Patent Term SUPPLEMENTARY INFORMATION section) are the docket and, except for those Restoration Act (Pub. L. 100–670) incorrect may submit either electronic submitted as ‘‘Confidential generally provide that a patent may be or written comments and ask for a Submissions,’’ publicly viewable at extended for a period of up to 5 years redetermination by November 22, 2016. http://www.regulations.gov or at the so long as the patented item (human Furthermore, any interested person may Division of Dockets Management drug product, animal drug product, petition FDA for a determination between 9 a.m. and 4 p.m., Monday medical device, food additive, or color regarding whether the applicant for 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 March 22, 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 drug Electronic Submissions with a heading or cover note that states products, the testing phase begins when Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical following way: CONFIDENTIAL INFORMATION’’. The investigations of the drug becomes • Federal eRulemaking Portal: http:// Agency will review this copy, including effective and runs until the approval www.regulations.gov. Follow the the claimed confidential information, in phase begins. The approval phase starts instructions for submitting comments. its consideration of comments. The with the initial submission of an Comments submitted electronically, second copy, which will have the application to market the human drug including attachments, to http:// claimed confidential information product and continues until FDA grants sradovich on DSK3GMQ082PROD with NOTICES www.regulations.gov will be posted to redacted/blacked out, will be available permission to market the drug product. the docket unchanged. Because your for public viewing and posted on http:// Although only a portion of a regulatory comment will be made public, you are www.regulations.gov. Submit both review period may count toward the solely responsible for ensuring that your copies to the Division of Dockets actual amount of extension that the comment does not include any Management. If you do not wish your Director of USPTO may award (for confidential information that you or a name and contact information to be example, half the testing phase must be third party may not wish to be posted, made publicly available, you can subtracted as well as any time that may VerDate Sep<11>2014 18:22 Sep 22, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1

65656 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices have occurred before the patent was 3. The date the application was application to the Director of the U.S. issued), FDA’s determination of the approved: October 22, 2012. FDA has Patent and Trademark Office (USPTO), length of a regulatory review period for verified the applicant’s claim that NDA Department of Commerce, for the a human drug product will include all 202834 was approved on October 22, extension of a patent which claims that of the testing phase and approval phase 2012. human biological product. as specified in 35 U.S.C. 156(g)(1)(B). This determination of the regulatory DATES: Anyone with knowledge that any FDA has approved for marketing the review period establishes the maximum of the dates as published (see the human drug product FYCOMPA potential length of a patent extension. SUPPLEMENTARY INFORMATION section) are (perampanel). FYCOMPA is indicated as However, the USPTO applies several incorrect may submit either electronic adjunctive therapy for the treatment of statutory limitations in its calculations or written comments and ask for a partial-onset seizures with or without of the actual period for patent extension. redetermination by November 22, 2016. secondarily generalized seizures in In its application for patent extension, Furthermore, any interested person may patients with epilepsy aged 12 years and this applicant seeks 1,549 days of patent petition FDA for a determination older. Subsequent to this approval, the term extension. regarding whether the applicant for USPTO received a patent term extension acted with due diligence restoration application for FYCOMPA III. Petitions during the regulatory review period by (U.S. Patent No. 6,949,571) from Eisai Anyone with knowledge that any of March 22, 2017. See ‘‘Petitions’’ in the R&D Management Co., Ltd., and the the dates as published are incorrect may SUPPLEMENTARY INFORMATION section for USPTO requested FDA’s assistance in submit either electronic or written more information. determining this patent’s eligibility for comments and ask for a redetermination patent term restoration. In a letter dated (see DATES). Furthermore, any interested ADDRESSES: You may submit comments March 26, 2014, FDA advised the person may petition FDA for a as follows: USPTO that this human drug product determination regarding whether the Electronic Submissions had undergone a regulatory review applicant for extension acted with due period and that the approval of diligence during the regulatory review Submit electronic comments in the FYCOMPA represented the first period. To meet its burden, the petition following way: permitted commercial marketing or use must be timely (see DATES) and contain • Federal eRulemaking Portal: http:// of the product. Thereafter, the USPTO sufficient facts to merit an FDA www.regulations.gov. Follow the requested that FDA determine the investigation. (See H. Rept. 857, part 1, instructions for submitting comments. product’s regulatory review period. 98th Cong., 2d sess., pp. 41–42, 1984.) Comments submitted electronically, Petitions should be in the format including attachments, to http:// II. Determination of Regulatory Review www.regulations.gov will be posted to Period specified in 21 CFR 10.30. Submit petitions electronically to the docket unchanged. Because your FDA has determined that the http://www.regulations.gov at Docket comment will be made public, you are applicable regulatory review period for No. FDA–2013–S–0610. Submit written solely responsible for ensuring that your FYCOMPA is 3,274 days. Of this time, petitions (two copies are required) to the comment does not include any 2,968 days occurred during the testing Division of Dockets Management (HFA– confidential information that you or a phase of the regulatory review period, 305), Food and Drug Administration, third party may not wish to be posted, while 306 days occurred during the 5630 Fishers Lane, Rm. 1061, Rockville, such as medical information, your or approval phase. These periods of time MD 20852. anyone else’s Social Security number, or were derived from the following dates: confidential business information, such 1. The date an exemption under Dated: September 19, 2016. as a manufacturing process. Please note section 505(i) of the Federal Food, Drug, Leslie Kux, that if you include your name, contact and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy. information, or other information that U.S.C. 355(i)) became effective: [FR Doc. 2016–22933 Filed 9–22–16; 8:45 am] identifies you in the body of your November 7, 2003. FDA has verified the BILLING CODE 4164–01–P comments, that information will be Eisai R&D Management Co., Ltd. claim posted on http://www.regulations.gov. that November 7, 2003, is the date the • If you want to submit a comment investigational new drug application DEPARTMENT OF HEALTH AND with confidential information that you became effective. HUMAN SERVICES do not wish to be made available to the 2. The date the application was public, submit the comment as a initially submitted with respect to the Food and Drug Administration written/paper submission and in the human drug product under section [Docket Nos. FDA–2014–E–2360 and FDA– manner detailed (see ‘‘Written/Paper 505(b) of the FD&C Act: December 22, 2014–E–2361] Submissions’’ and ‘‘Instructions’’). 2011. The applicant claims May 25, 2011, as the date that the new drug Determination of Regulatory Review Written/Paper Submissions application (NDA) for Fycompa (NDA Period for Purposes of Patent Submit written/paper submissions as 202834) was initially submitted. Extension; MYALEPT follows: However, FDA records indicate that AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for NDA 202834, received May 25, 2011, HHS. written/paper submissions): Division of was not sufficiently complete to permit ACTION: Notice. Dockets Management (HFA–305), Food a substantive review. FDA refused to file and Drug Administration, 5630 Fishers sradovich on DSK3GMQ082PROD with NOTICES this application and notified the SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. applicant of this fact by letter dated July Administration (FDA) has determined • For written/paper comments 21, 2011. The completed NDA was then the regulatory review period for submitted to the Division of Dockets submitted on December 22, 2011, which MYALEPT and is publishing this notice Management, FDA will post your is considered to be the date that the of that determination as required by comment, as well as any attachments, NDA was initially submitted within the law. FDA has made the determination except for information submitted, meaning of 35 U.S.C. 156(g)(B)(ii). because of the submission of an marked and identified, as confidential, VerDate Sep<11>2014 18:22 Sep 22, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1


Document Created: 2016-09-23 01:43:38
Document Modified: 2016-09-23 01:43:38
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 November 22, 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 March 22, 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 65655 
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