[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75679-75680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30510]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0584]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BESIVANCE
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 BESIVANCE 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
[[Page 75680]]
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
BESIVANCE (besifloxacin hydrochloride). BESIVANCE is indicated for
treatment of bacterial conjunctivitis. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for BESIVANCE (U.S. Patent No. 5,447,926) from Bausch &
Lomb Inc., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated May 10, 2010, FDA advised the Patent and
Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of BESIVANCE 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
BESIVANCE is 2,271 days. Of this time, 1,910 days occurred during the
testing phase of the regulatory review period, while 361 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: March 12, 2003. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on March 12, 2003.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 2,
2008. FDA has verified the applicant's claim that the new drug
application (NDA) for Besivance (NDA 22-308) was submitted on June 2,
2008.
3. The date the application was approved: May 28, 2009. FDA has
verified the applicant's claim that NDA 22-308 was approved on May 28,
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 1,316 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 4, 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 6, 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 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. 2010-30510 Filed 12-3-10; 8:45 am]
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