[Federal Register Volume 61, Number 53 (Monday, March 18, 1996)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6454]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95E-0364]
Determination of Regulatory Review Period for Purposes of Patent
AGENCY: Food and Drug Administration, HHS.
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
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
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]
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