[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]
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