[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37399-37400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18407]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97E-0359]
Determination of Regulatory Review Period for Purposes of Patent
Extension; FlowmaxTM
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 FlowmaxTM 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, 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 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
FlowmaxTM (tamsulosin hydrochloride). FlowmaxTM
is indicated for the treatment of the signs and symptoms of benign
prostatic hyperplasia (BPH). Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
FlowmaxTM (U.S. Patent No. 4,868,216) from Yamanouchi
Pharmaceutical, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated November 7, 1997, FDA advised the Patent
and Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of FlowmaxTM
represented the first permitted commercial marketing or use of the
product. Shortly thereafter, the Patent and Trademark Office requested
that the FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
FlowmaxTM is 3,529 days. Of this time, 3,163 days occurred
during the testing phase of the regulatory review period, 366 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date an exemption under section 505 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective:
August 19, 1987. FDA has verified the applicant's claim that the date
the investigational new
[[Page 37400]]
drug application became effective was on August 19, 1987.
2. The date the application was initially submitted with respect
to the human drug product under section 505 of the act: April 15, 1996.
FDA has verified the applicant's claim that the new drug application
(NDA) for FlowmaxTM (NDA 20-579) was initially submitted on
April 15, 1996.
3. The date the application was approved: April 15, 1997. FDA has
verified the applicant's claim that NDA 20-579 was approved on April
15, 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 1,669 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 6, 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: June 23, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-18407 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F
