[Federal Register Volume 62, Number 170 (Wednesday, September 3, 1997)]
[Notices]
[Pages 46501-46502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23244]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0145]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; PRELAY<SUP>TM</SUP> and REZULIN<SUP>TM</SUP>

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for PRELAY<SUP>TM</SUP> and 
REZULIN<SUP>TM</SUP> 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 products 
PRELAY<SUP>TM</SUP> and REZULIN<SUP>TM</SUP> (troglitazone). 
PRELAY<SUP>TM</SUP> and REZULIN<SUP>TM</SUP> are indicated for use in 
patients with type II diabetes currently on insulin therapy whose 
hyperglycemia is inadequately controlled (HbA<INF>lc</INF>>8.5%) 
despite insulin therapy of over 30 units per day given as multiple 
injections. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for 
PRELAY<SUP>TM</SUP> and REZULIN<SUP>TM</SUP> (U.S. Patent No. 
4,572,912) from Sankyo Co., Ltd., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated January 21, 1997, FDA 
advised the Patent and Trademark

[[Page 46502]]

Office that these human drug products had undergone a regulatory review 
period and that the approvals of PRELAY<SUP>TM</SUP> and 
REZULIN<SUP>TM</SUP> represented the first permitted commercial 
marketing or use of the products. 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 
PRELAY<SUP>TM</SUP> and REZULIN<SUP>TM</SUP> is 2,885 days. Of this 
time, 2,703 days occurred during the testing phase of the regulatory 
review period, while 182 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: March 9, 
1989. FDA has verified the applicant's claim that the date that the 
investigational new drug application became effective was on March 9, 
1989.
    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: August 1, 1996. The applicant claims July 31, 1996, 
as the date the New Drug Applications (NDA's) for PRELAY<SUP>TM</SUP> 
(NDA 20-719) and REZULIN<SUP>TM</SUP> (NDA 20-720) were initially 
submitted. However, FDA records indicate that NDA's 20-719 and 20-720 
were submitted on August 1, 1996.
    3. The date the application was approved: January 29, 1997. FDA has 
verified the applicant's claim that NDA's 20-719 and 20-720 were 
approved on January 29, 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 1,534 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before November 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 March 2, 1998, 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 24, 1997.
 Allen B. Duncan,
 Acting Associate Commissioner for Health Affairs.
[FR Doc. 97-23244 Filed 9-2-97; 8:45 am]
BILLING CODE 4160-01-F