[Federal Register: December 1, 2003 (Volume 68, Number 230)]
[Notices]
[Page 67194-67195]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de03-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0246]
Determination of Regulatory Review Period for Purposes of Patent
Extension; DERAMAXX
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 DERAMAXX 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 Grillo, Office of Regulatory
Policy (HFD-013), Center for Drug Evaluation and Research, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-
6699.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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
[[Page 67195]]
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
DERAMAXX (deracoxib). DERAMAXX is indicated for the control of
postoperative pain and inflammation associated with orthopedic surgery.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for DERAMAXX (U.S. Patent No.
5,521,207) from G. D. Searle L.L.C., and the Patent and Trademark
Office requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated July 16,
2003, FDA advised the Patent and Trademark Office that this animal drug
product had undergone a regulatory review period and that the approval
of DERAMAXX represented the first permitted commercial marketing or use
of the product. Shortly 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
DERAMAXX is 1,675 days. Of this time, 1,578 days occurred during the
testing phase of the regulatory review period, and 97 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(j)) involving this animal drug
product became effective: January 21, 1998. The applicant claims
January 27, 1998, 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 January 21,
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: May 17, 2002.
FDA has verified the applicant's claim that the new animal drug
application (NADA) for DERAMAXX (NADA 141-203) was initially submitted
on May 17, 2002.
3. The date the application was approved: August 21, 2002. FDA has
verified the applicant's claim that NADA 141-203 was approved on August
21, 2002.
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 882 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 January 30, 2004. 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 1,
2004. 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 (see ADDRESSES). 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: October 29, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-29742 Filed 11-28-03; 8:45 am]
BILLING CODE 4160-01-S