Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836, 67947-67948 [2019-26813]

Download as PDF Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26812 Filed 12–11–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–E–2528] Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT ORAL TABLETS 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 10, 2020. 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 9, 2020. See ‘‘Petitions’’ in the khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:56 Dec 11, 2019 Jkt 250001 SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 10, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–E–2528 for ‘‘Determination of Regulatory Review Period for Purposes PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 67947 of Patent Extension; BRIVIACT ORAL TABLETS.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: E:\FR\FM\12DEN1.SGM 12DEN1 khammond on DSKJM1Z7X2PROD with NOTICES 67948 Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices 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, if a patent is eligible for extension under these acts, the 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 the drug product ‘‘was approved’’ within the meaning of 35 U.S.C. 156. In the case of a drug recommended for controls under the Controlled Substances Act (CSA), for purposes of patent term extension the date of approval is the later of the date the application to market the drug is approved or the date of issuance of the interim final rule controlling the drug. (See 35 U.S.C. 156(i)). Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product BRIVIACT ORAL TABLETS (brivaracetam) under new drug application (NDA) 205836. BRIVIACT ORAL TABLETS is indicated for adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. Subsequent to this approval, the USPTO received a patent term restoration application for BRIVIACT ORAL TABLETS (U.S. Patent No. 6,911,461) from UCB Biopharma SPRL and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated VerDate Sep<11>2014 17:56 Dec 11, 2019 Jkt 250001 January 18, 2017, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BRIVIACT ORAL TABLETS 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 BRIVIACT ORAL TABLETS is 4,293 days. Of this time, 3,753 days occurred during the testing phase of the regulatory review period, while 540 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: August 12, 2004. FDA has verified the applicant’s claim that the date the investigational new drug application (IND) became effective was August 12, 2004. This IND was the first IND submitted for investigation of this active ingredient. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 20, 2014. FDA has verified the applicant’s claim that the NDA for BRIVIACT ORAL TABLETS (NDA 205836) was initially submitted on November 20, 2014. 3. For a drug recommended for controls under the CSA, the later of the date the NDA was approved under section 505 of the FD&C Act or the date of issuance of the interim final rule controlling the drug: May 12, 2016. FDA has verified the applicant’s claim that NDA 205836 was approved on February 18, 2016. FDA has also verified that the date of issuance of the interim final rule controlling the drug, placing BRIVIACT ORAL TABLETS (brivaracetam) in schedule V of the CSA as revised by the Improving Regulatory Transparency for New Medical Therapies Act, was May 12, 2016. 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 5 years of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26813 Filed 12–11–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Center for Advancing Translational Sciences Advisory Council. The meeting will be open to the public as indicated below, viewing virtually by WebEx. Individuals can register to view and access the meeting by the link below. https://nih.webex.com/nih/onstage/ g.php?MTID=e56b929e2a7d82a92a 5e58e040d7d103d 1. Go to ‘‘Event Status’’ on the lefthand side of page, then click ‘‘Register’’. On the registration form, enter your information and then click ‘‘Submit’’ to complete the required registration. 2. You will receive a personalized email with the live event link. The meeting will be closed to the public in accordance with the E:\FR\FM\12DEN1.SGM 12DEN1

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[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67947-67948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26813]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2528]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for BRIVIACT ORAL TABLETS 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 (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
February 10, 2020. 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 9, 2020. 
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 10, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-E-2528 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; BRIVIACT ORAL TABLETS.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

[[Page 67948]]

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, if a patent 
is eligible for extension under these acts, the 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 the drug product ``was approved'' within the meaning of 
35 U.S.C. 156. In the case of a drug recommended for controls under the 
Controlled Substances Act (CSA), for purposes of patent term extension 
the date of approval is the later of the date the application to market 
the drug is approved or the date of issuance of the interim final rule 
controlling the drug. (See 35 U.S.C. 156(i)). Although only a portion 
of a regulatory review period may count toward the actual amount of 
extension that the Director of USPTO may award (for example, half the 
testing phase must be subtracted as well as any time that may have 
occurred before the patent was issued), FDA's determination of the 
length of a regulatory review period for a human drug product will 
include all of the testing phase and approval phase as specified in 35 
U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product BRIVIACT ORAL 
TABLETS (brivaracetam) under new drug application (NDA) 205836. 
BRIVIACT ORAL TABLETS is indicated for adjunctive therapy in the 
treatment of partial-onset seizures in patients 16 years of age and 
older with epilepsy. Subsequent to this approval, the USPTO received a 
patent term restoration application for BRIVIACT ORAL TABLETS (U.S. 
Patent No. 6,911,461) from UCB Biopharma SPRL and the USPTO requested 
FDA's assistance in determining the patent's eligibility for patent 
term restoration. In a letter dated January 18, 2017, FDA advised the 
USPTO that this human drug product had undergone a regulatory review 
period and that the approval of BRIVIACT ORAL TABLETS 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 
BRIVIACT ORAL TABLETS is 4,293 days. Of this time, 3,753 days occurred 
during the testing phase of the regulatory review period, while 540 
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 (FD&C Act) (21 U.S.C. 355(i)) became effective: 
August 12, 2004. FDA has verified the applicant's claim that the date 
the investigational new drug application (IND) became effective was 
August 12, 2004. This IND was the first IND submitted for investigation 
of this active ingredient.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: November 
20, 2014. FDA has verified the applicant's claim that the NDA for 
BRIVIACT ORAL TABLETS (NDA 205836) was initially submitted on November 
20, 2014.
    3. For a drug recommended for controls under the CSA, the later of 
the date the NDA was approved under section 505 of the FD&C Act or the 
date of issuance of the interim final rule controlling the drug: May 
12, 2016. FDA has verified the applicant's claim that NDA 205836 was 
approved on February 18, 2016. FDA has also verified that the date of 
issuance of the interim final rule controlling the drug, placing 
BRIVIACT ORAL TABLETS (brivaracetam) in schedule V of the CSA as 
revised by the Improving Regulatory Transparency for New Medical 
Therapies Act, was May 12, 2016.
    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 5 years of patent term extension.

III. Petitions

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

    Dated: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26813 Filed 12-11-19; 8:45 am]
BILLING CODE 4164-01-P