[Federal Register Volume 66, Number 184 (Friday, September 21, 2001)]
[Notices]
[Pages 48687-48688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0089]


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

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 Kaletra 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 that 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

[[Page 48688]]

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 Kaletra 
(lopinavir). Kaletra is indicated in combination with other 
antiretroviral agents for the treatment of HIV-1 infections in adults 
and pediatric patients age 6 months and older. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for Kaletra (U.S. Patent No. 5,886,036) from 
Abbott Laboratories, Inc., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated May 11, 2001, FDA advised 
the Patent and Trademark Office that this human drug product had 
undergone a regulatory review period and that the approval of Kaletra 
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 
Kaletra is 1,397 days. Of this time, 1,290 days occurred during the 
testing phase of the regulatory review period, while 107 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 (the act) (21 U.S.C. 355(i)) became effective: 
November 20, 1996. The applicant claims November 18, 1996, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was November 
20, 1996, 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(b) of the act: June 1, 2000. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for Kaletra (NDA 21-226) was initially submitted on June 1, 2000.
    3. The date the application was approved: September 15, 2000. FDA 
has verified the applicant's claim that NDA 21-226 was approved on 
September 15, 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 324 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 comments and ask for a redetermination by November 20, 2001. 
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 March 20, 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. Three copies of any information are to be submitted, 
except that individuals may submit one copy. Comments are to be 
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: September 5, 2001.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 01-23700 Filed 9-20-01; 8:45 am]
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