[Federal Register: February 3, 2006 (Volume 71, Number 23)]
[Notices]
[Page 5859-5860]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe06-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E-0389]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SURPASS
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 SURPASS 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 animal drug product.
ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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 animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b(j)) became effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the animal 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 an animal drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing the animal drug product SURPASS
(diclofenac sodium). SURPASS is indicated for the control of pain and
inflammation associated with osteoarthritis in tarsal, carpal,
metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal
(hock, knee, fetlock, and pastern) joints in horses. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for SURPASS (U.S. Patent No. 4,937,078) from
Mezei Associates, 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 April 8, 2005, FDA advised the
Patent and Trademark Office that this animal drug product had undergone
a regulatory review period and that the approval of SURPASS 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.
[[Page 5860]]
FDA has determined that the applicable regulatory review period for
SURPASS is 2,262 days. Of this time, 1,028 days occurred during the
testing phase of the regulatory review period, while 1,234 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date an exemption under subsection 512(j) of the act became
effective: March 6, 1998. The applicant claims January 11, 1999, as the
date the investigational new animal drug application (INAD) became
effective. However, FDA records indicate that the date of FDA's letter
assigning a number to the INAD was March 6, 1998, which is considered
to be the effective date for the INAD.
2. The date the application was initially submitted with respect to
the animal drug product under section 512(b) of the act: December 27,
2000. The applicant claims January 2, 2001, as the date the new animal
drug application (NADA) for SURPASS (NADA 141-186) was initially
submitted. However, a review of FDA records reveals that the date of
FDA's official acknowledgement letter assigning a number to NADA 141-
186 was December 27, 2000, which is considered to be the initially
submitted date for NADA 141-186.
3. The date the application was approved: May 13, 2004. FDA has
verified the applicant's claim that NADA 141-186 was approved on May
13, 2004.
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 1,590 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) written or electronic comments and ask for a redetermination
by April 4, 2006. 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 August 2,
2006. 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.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-1434 Filed 2-2-06; 8:45 am]
BILLING CODE 4160-01-S