[Federal Register Volume 62, Number 65 (Friday, April 4, 1997)]
[Notices]
[Page 16166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8624]
[[Page 16166]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0441]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TRITEC
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 TRITEC 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 human 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 human 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 human 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 a human 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 human drug product
TRITEC (ranitidine bismuth citrate). TRITEC in
combination with clarithromycin is indicated for the treatment of
patients with an active duodenal ulcer associated with H. pylori
infection. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for TRITEC
(U.S. Patent No. 5,008,256) from Glaxo Wellcome, Inc., and the Patent
and Trademark Office requested FDA's assistance in determining this
patient's eligibility for patent term restoration. In a letter dated
January 13, 1997, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of TRITEC 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
TRITEC is 1,074 days. Of this time, 485 days occurred during
the testing phase of the regulatory review period, while 589 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September
1, 1993. FDA has verified the applicant's claim that the date that the
investigation new drug application became effective was on September 1,
1993.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the Federal Food, Drug,
and Cosmetic Act: December 29, 1994. FDA has verified the applicant's
claim that the new drug application (NDA) for TRITEC (NDA 20-
559) was initially submitted on December 29, 1994.
3. The date the application was approved: August 8, 1996. FDA has
verified the applicant's claim that NDA 20-559 was approved on August
8, 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 831 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before June 3, 1997 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 October 1, 1997 for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period. To meet, 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 27, 1997.
Allen B. Duncan,
Acting Associate Commissioner for Health Affairs.
[FR Doc. 97-8624 Filed 4-3-97; 8:45 am]
BILLING CODE 4160-01-F
