[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 EPRINEXTM 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 EPRINEXTM
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 EPRINEXTM Pour-On for Beef and Dairy Cattle
(eprinomectin). IVOMEC EPRINEXTM Pour-On for Beef
and Dairy Cattle is indicated for treatment and control of
gastrointestinal nematodes (adults and fourth stage larvae,
L4), lungworms (adults and L4), 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 EPRINEXTM 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
EPRINEXTM 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 EPRINEXTM 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 EPRINEXTM 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
