[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Notices]
[Pages 60708-60709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30388]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96E-0196]


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

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 DOMITOR 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, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

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.

[[Page 60709]]

    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 (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 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 
DOMITOR (medetomidine hydrochloride). DOMITOR is 
indicated as a sedative and analgesic in dogs over 12 weeks of age to 
facilitate clinical examinations, clinical procedures, minor surgical 
procedures not requiring muscle relaxation, and minor dental procedures 
not requiring intubation. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
DOMITOR (U.S. Patent No. 4,544,664) from ORION-YHTYMA OY and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated August 20, 1996, FDA advised the Patent and Trademark 
Office that this animal drug product had undergone a regulatory review 
period and that the approval of DOMITOR represented the first 
commercial marketing 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 
DOMITOR is 4,000 days. Of this time, 2,294 days occurred 
during the testing phase of the regulatory review period, while 1,706 
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 became effective: April 8, 1985. FDA has 
verified the applicant's claim that April 8, 1985, was the date the 
investigational new animal drug application became effective.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the Federal Food, Drug, 
and Cosmetic Act: July 19, 1991. The applicant claims July 2, 1991, as 
the date the new animal drug application (NADA) for DOMITOR 
(NADA 140-999) was initially submitted. However, a review of FDA 
records reveals that the date of FDA's official acknowledgement letter 
assigning a number to the NADA was July 19, 1991, which is considered 
to be the initially submitted date for the NADA.
    3. The date the application was approved: March 19, 1996. FDA has 
verified the applicant's claim that NADA 140-999 was approved on March 
19, 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 January 28, 1997, 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 May 28, 1997, 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: November 20, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-30388 Filed 11-27-96; 8:45 am]
BILLING CODE 4160-01-F