[Federal Register Volume 67, Number 17 (Friday, January 25, 2002)]
[Notices]
[Pages 3724-3725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0363]


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

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 MIFEPREX 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: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 MIFEPREX 
(mifepristone). MIFEPREX is indicated for the medical termination of 
intrauterine pregnancy through 49 days pregnancy. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for MIFEPREX (U.S. Patent No. 4,386,085) from 
the Population Council, and the Patent and Trademark Office requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated October 2, 2001, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of MIFEPREX 
represented the first permitted commercial marketing or use of the 
product. Shortly thereafter,

[[Page 3725]]

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 
MIFEPREX is 2,249 days. Of this time, 593 days occurred during the 
testing phase of the regulatory review period, while 1,656 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: The 
applicant claims August 3, 1994, as the date the investigational new 
drug application (IND) became effective. However, FDA records indicate 
that the IND effective date was August 4, 1994, which was 30 days after 
FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the act: March 18, 1996. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for MIFEPREX (NDA 20-687) was initially submitted on March 18, 
1996.
    3. The date the application was approved: September 28, 2000. FDA 
has verified the applicant's claim that NDA 20-687 was approved on 
September 28, 2000.
    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 1,825 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (address above) 
written or electronic comments and ask for a redetermination by March 
26, 2002. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by July 24, 2002. 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: December 14, 2001.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-1926 Filed 1-24-02; 8:45 am]
BILLING CODE 4160-01-S