[Federal Register Volume 61, Number 53 (Monday, March 18, 1996)]
[Pages 11054-11055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6454]


Food and Drug Administration
[Docket No. 95E-0364]

Determination of Regulatory Review Period for Purposes of Patent 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for IMMITICIDE 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.-
    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 
IMMITICIDE (melarsomine dihydrochloride). 
IMMITICIDE is indicated for the treatment of stabilized Class 
1, 2, and 3 heartworm disease caused by immature (4-month old, stage 
L5) to mature adult infections of Dirofilaria immitis in dogs. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for IMMITICIDE (U.S. 
Patent No. 4,514,390) from Rockefeller University and the Patent and 
Trademark Office requested FDA's assistance in determining the patent's 
eligibility for patent term restoration. In a letter dated November 24, 
1995, FDA advised the Patent and Trademark Office that this animal drug 
product had undergone a regulatory review period and that the approval 
of IMMITICIDE 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 
IMMITICIDE is 2,650 days. Of this time, 2,037 days occurred 
during the testing phase of the regulatory review period, while 613 
days occurred during the approval phase. These periods of

[[Page 11055]]
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 20, 1988. FDA has 
verified the applicant's claim that the date the investigational new 
drug application became effective was April 20, 1988.
    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: November 16, 1993. The applicant claims November 5, 
1993, as the date the new animal drug application (NADA) for 
IMMITICIDE (NADA 141-042) was initially submitted. However, a 
review of FDA records reveals that the date of FDA's official 
acknowledgment letter assigning a number to the NADA was November 16, 
1993, which is considered to be the initially submitted date for the 
     3. The date the animal drug was approved: July 21, 1995. FDA has 
verified the applicant's claim that NADA 141-042 was approved on July 
21, 1995.
    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 April 17, 1996, 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 September 16, 1996, 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: March 8, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-6454 Filed 3-15-96; 8:45 am]