[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67942-67944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26814]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-2529]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BRIVIACT ORAL SOLUTION, New Drug Application 205838
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for BRIVIACT ORAL SOLUTION 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.
[[Page 67943]]
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-2529 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BRIVIACT ORAL SOLUTION.'' 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:
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,
a drug is considered to have been approved on 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
SOLUTION (brivaracetam) under new drug application (NDA) 205838.
BRIVIACT ORAL SOLUTION 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 SOLUTION (U.S.
Patent No. 8,492,416) 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 SOLUTION 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 SOLUTION 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. The applicant claims December 22, 2010, as the date
the investigational new drug application (IND) became effective.
However, according to FDA records, this IND was not the first IND
received for this active ingredient. In general, FDA has used the first
IND submitted for investigation of the active ingredient of the drug
product as the beginning of the testing phase, if information derived
from this first IND was or could have been relied on or was relevant
for approval to market the drug product. FDA records indicate that the
effective date of the first IND for brivaracetam was August 12, 2004,
which was 30 days after FDA receipt of this first IND. This is the same
IND and
[[Page 67944]]
the same date FDA determined was the beginning of the regulatory review
period for BRIVIACT ORAL TABLETS approved under NDA 205836 and for
BRIVIACT INJECTION approved under NDA 205837. The regulatory review
period determinations for BRIVIACT ORAL TABLETS and BRIVIACT INJECTION
are published in this issue of the Federal Register.
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 SOLUTION (NDA 205838) 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 205838 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 SOLUTION (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 698 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, 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. 2019-26814 Filed 12-11-19; 8:45 am]
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