[Federal Register Volume 68, Number 30 (Thursday, February 13, 2003)]
[Notices]
[Pages 7382-7383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1239]


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

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 Rapamune 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 Director 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/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

[[Page 7383]]


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 Director 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 Rapamune 
(sirolimus (also rapamycin)). Rapamune is indicated for prophylaxis of 
organ rejection in patients receiving renal transplants. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for Rapamune (U.S. Patent No. 5,100,899) from 
Sir Roy Caine, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated April 13, 2000, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of Rapamune represented 
the first permitted commercial marketing or use of the product. 
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 
Rapamune is 2,709 days. Of this time, 2,434 days occurred during the 
testing phase of the regulatory review period, while 275 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: 
April 17, 1992. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on April 
17, 1992.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the act: December 15, 1998. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for Rapamune (NDA 21-083) was initially submitted on December 15, 
1998.
    3. The date the application was approved: September 15, 1999. FDA 
has verified the applicant's claim that NDA 21-083 was approved on 
September 15, 1999.
    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 1,492 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written comments and ask for a redetermination by April 14, 2003. 
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 August 12, 2003. 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 a single copy. Copies 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: January 13, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-3556 Filed 2-12-03; 8:45 am]
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