[Federal Register Volume 61, Number 105 (Thursday, May 30, 1996)]
[Notices]
[Pages 27085-27086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13535]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0385]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; PRECOSETM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for PRECOSETM 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

[[Page 27086]]

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 
PRECOSETM (acarbose). PRECOSETM is indicated as an adjunct to 
diet to lower blood glucose in patients with noninsulin-dependent 
diabetes mellitus who hyperglycemia cannot be managed by diet alone. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for PRECOSETM (U.S. Patent No. 
4,904,769) from Bayer AG, and the Patent and Trademark Office requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated December 27, 1995, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period that the approval of PRECOSETM 
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 
PRECOSETM is 5,647 days. Of this time, 3,789 days occurred during 
the testing phase of the regulatory review period, while 1,858 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 23, 
1980. FDA has verified the applicant's claim that the date that the 
investigational new drug application became effective was on March 23, 
1980.
    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 6, 1990. The applicant claims August 9, 1990, 
as the date the new drug application (NDA) for PRECOSETM (NDA 20-
086) was initially submitted. However, FDA records indicate that NDA 
20-086 for the active ingredient in PRECOSETM (acarbose) was 
received by the agency on August 6, 1990. This NDA was withdrawn on 
August 28, 1991. A subsequent NDA for PRECOSETM (NDA 20-482) was 
received on September 6, 1994. Therefore, NDA 20-086 signifies the end 
of the testing phase and the beginning of the approval phase for 
PRECOSETM, while NDA 20-482 signifies the end of the approval 
phase. The NDA initially submitted date is August 6, 1990.
    3. The date the application was approved: September 6, 1995. FDA 
verified the applicant's claim that NDA 20-482 was approved on 
September 6, 1995.
    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 922 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before July 29, 1996, 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 November 26, 1996, 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: May 16, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-13535 Filed 5-29-96; 8:45 am]
BILLING CODE 4160-01-F