[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Notices]
[Pages 36922-36923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0308]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; IVOMEC<Register> EPRINEX<SUP>TM</SUP> Pour-On for Beef and 
Dairy Cattle

AGENCY: Food and Drug Administration, HHS.


[[Page 36923]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for IVOMEC<Register> EPRINEX<SUP>TM</SUP> 
Pour-On for Beef and Dairy Cattle 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)(1)(B).
    FDA recently approved for marketing the animal drug product 
IVOMEC<Register> EPRINEX<SUP>TM</SUP> Pour-On for Beef and Dairy Cattle 
(eprinomectin). IVOMEC<Register> EPRINEX<SUP>TM</SUP> Pour-On for Beef 
and Dairy Cattle is indicated for treatment and control of 
gastrointestinal nematodes (adults and fourth stage larvae, 
L<INF>4</INF>), lungworms (adults and L<INF>4</INF>), cattle grubs (all 
parasitic stages), lice, mange mites, and flies. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for IVOMEC<Register> EPRINEX<SUP>TM</SUP> Pour-
On for Beef and Dairy Cattle (U.S. Patent No. 4,427,663) from Merck & 
Co., Inc., 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 7, 1997, FDA advised the Patent 
and Trademark Office that this animal drug product had undergone a 
regulatory review period and that the approval of IVOMEC<Register> 
EPRINEX<SUP>TM</SUP> Pour-On for Beef and Dairy Cattle 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 
IVOMEC<Register> EPRINEX<SUP>TM</SUP> Pour-On for Beef and Dairy Cattle 
is 2,492 days. Of this time, 2,475 days occurred during the testing 
phase of the regulatory review period, while 17 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: 
June 22, 1990. FDA has verified the applicant's claim that the date the 
investigational new animal drug application became effective was on 
June 22, 1990.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the act: March 31, 
1997. The applicant claims March 27, 1997, as the date the new animal 
drug application (NADA) for IVOMEC<Register> EPRINEX<SUP>TM</SUP> Pour-
On for Beef and Dairy Cattle (NADA 141-079) was initially submitted. 
However, FDA records indicate that the date of FDA's official 
acknowledgement letter assigning a number to NADA 141-079 was March 31, 
1997, which is considered to be the initially submitted date for NADA 
141-079.
    3. The date the application was approved: April 16, 1997. FDA has 
verified the applicant's claim that NADA 141-079 was approved on April 
16, 1997.
    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 1,255 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before September 8, 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 January 4, 1999 publication in the Federal Register), 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: June 23, 1998.
Thomas J. McGinnis,
 Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-18141 Filed 7-7-98; 8:45 am]
BILLING CODE 4160-01-F