[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]
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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.
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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
