[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76740-76741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30991]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-E-0044]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BEPREVE
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 BEPREVE 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 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. 6222, Silver Spring, MD 20993-0002, 301-796-3602.
SUPPLEMENTARY INFORMATION: 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 Patents and
Trademarks 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 recently approved for marketing the human drug product BEPREVE
(bepotastine besilate). BEPREVE is indicated for the treatment of
itching associated with allergic conjunctivitis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for BEPREVE (U.S. Patent No. 6,780,877) from
Ube Industries, Ltd., and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated March 3, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of BEPREVE represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
BEPREVE is 964 days. Of this time, 663 days occurred during the testing
phase of the regulatory review period, while 301 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: January 20, 2007. The applicant claims January 19, 2007, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was January 20, 2007, which was 30 days after FDA receipt of the IND.
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
12, 2008. FDA has verified the applicant's claim that the new drug
application (NDA) 22-288 was submitted on November 12, 2008.
3. The date the application was approved: September 8, 2009. FDA
has verified the applicant's claim that NDA 22-288 was approved on
September 8, 2009.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 631 days of
patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 7, 2011. 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 7, 2011. To meet its burden, the petition must 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies
[[Page 76741]]
of the petition. Identify comments with the docket number found in
brackets in the heading of this document. Comments and petitions that
have not been made publicly available on regulations.gov may be viewed
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-30991 Filed 12-8-10; 8:45 am]
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