[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]

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