[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Notices]
[Page 51939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25908]
[[Page 51939]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97E-0294]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Silvacote K
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 Silvacote K 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 food additive.
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 food additives, the testing
phase begins when a major health or environmental effects test
involving the food additive begins and runs until the approval phase
begins. The approval phase starts with the initial submission of a
petition requesting the issuance of a regulation for use of the food
additive and continues until FDA grants permission to market the food
additive 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 a food additive will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(2)(B).
FDA recently approved for marketing the food additive Silvacote K
(phosphorylated tall oil fatty acids). Silvacote K is indicated for use
as pigment dispersants in polymeric films intended for use in contact
with food. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for Silvacote K (U.S.
Patent No. 4,209,430) from SCM Chemicals, Inc., and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
October 21, 1997, FDA advised the Patent and Trademark Office that this
food additive had undergone a regulatory review period and that the
approval of Silvacote K 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
Silvacote K is 5,990 days. Of this time, 4,608 days occurred during the
testing phase of the regulatory review period, 1,382 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date a major health or environmental effects test
(``test'') involving this food additive additive product was begun:
March 30, 1980. The applicant claims November 6, 1992, as the date the
test was begun. However, FDA records indicate that the test was begun
on March 30, 1980.
2. The date the petition requesting the issuance of a regulation
for use of the additive (``petition'') was initially submitted with
respect to the food additive additive product under section 409 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348): November 9, 1992.
The applicant claims November 6, 1992, as the date the petition for
Silvacote K was initially submitted. However, FDA records indicate that
the petition was submitted on November 9, 1992.
3. The date the petition became effective: August 21, 1996. FDA has
verified the applicant's claim that the regulation for the food
additive became effective on August 21, 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 1,385 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before November 30, 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 March 29, 1999, 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: September 9, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-25908 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F
