[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97E-0145]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PRELAYTM and REZULINTM
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 PRELAYTM and
REZULINTM 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
PRELAYTM and REZULINTM (troglitazone).
PRELAYTM and REZULINTM are indicated for use in
patients with type II diabetes currently on insulin therapy whose
hyperglycemia is inadequately controlled (HbAlc>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
PRELAYTM and REZULINTM (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 PRELAYTM and
REZULINTM 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
PRELAYTM and REZULINTM 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 PRELAYTM
(NDA 20-719) and REZULINTM (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
