[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Notices]
[Pages 41581-41582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0152]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Dostinex Tablets

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 Dostinex Tablets 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 
Dostinex Tablets (cabergoline). Dostinex Tablets is 
indicated for the treatment of hyperprolactinemic disorders, either 
idiopathic or due to pituitary adenomas. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for Dostinex Tablets (U.S. Patent No. 4,526,892) 
from Upjohn & Pharmacia, and the Patent and Trademark Office requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated March 31, 1998, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of Dostinex 
Tablets 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 
Dostinex Tablets is 2,188 days. Of this time, 1,825 days 
occurred during the testing phase of the regulatory review period, 363 
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: 
December 29, 1990. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
December 29, 1990.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the act: December 27, 1995. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for Dostinex Tablets (NDA 20-664) was initially 
submitted on December 27, 1995.
    3.  The date the application was approved: December 23, 1996. FDA 
has verified the applicant's claim that NDA 20-664 was approved on 
December 23, 1996.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension.

[[Page 41582]]

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 1,273 days of patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 5, 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 February 1, 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: July 8, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-20739 Filed 8-3-98; 8:45 am]
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