[Federal Register Volume 63, Number 197 (Tuesday, October 13, 1998)]
[Notices]
[Page 54716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0012]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Rimadyl

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 Rimadyl 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 Commissioner of 
Patents and Trademarks, Department of Commerce, for the extension of a 
patent which claims that animal drug product.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

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 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 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 Commissioner 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 Rimadyl 
(carprofen). Rimadyl is indicated for the relief of pain and 
inflammation in dogs. Rimadyl was shown to be clinically effective for 
the relief of signs associated with osteoarthritis in dogs. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for Rimadyl (U.S. Patent No. 4,264,500) 
from Pfizer 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 January 22, 1997, FDA advised the Patent 
and Trademark Office that this animal drug product had undergone a 
regulatory review period and that the approval of Rimadyl 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 
Rimadyl is 6,572 days. Of this time, 5,910 days occurred during the 
testing phase of the regulatory review period, 662 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 (the act) (21 U.S.C. 360b(j)) became effective: 
October 30, 1978. The applicant claims August 23, 1979, 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 October 30, 1978, 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: January 3, 
1995. The applicant claims December 29, 1994, as the date the new 
animal drug application (NADA) for Rimadyl (NADA 141-053) 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-
053 was January 3, 1995, which is considered to be the initially 
submitted date for NADA 141-053.
    3. The date the application was approved: October 25, 1996. FDA has 
verified the applicant's claim that NADA 141-053 was approved on 
October 25, 1996.
    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 1,095 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before December 14, 1998, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before April 12, 1999, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. 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 Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: September 28, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-27285 Filed 10-9-98; 8:45 am]
BILLING CODE 4160-01-F