[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Page 41509-41510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0249]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ELITEK 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 
which claims that human biological product.

ADDRESSES: Submit written or electronic comments and petitions to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-453-6699.

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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 biological 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 biological product 
ELITEK (rasburicase). ELITEK is indicated for the initial management of 
plasma uric acid levels in pediatric patients with leukemia, lymphoma, 
and solid-tumor malignancies who are receiving anti-cancer therapy 
expected to result in tumor lysis and subsequent elevation of plasma 
uric acid. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for ELITEK (U.S. Patent 
No. 5,382,518) from Sanofi-Synthelabo, and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated November 18, 
2003, FDA advised the Patent and Trademark Office that this human 
biologic product had undergone a regulatory review period and that the 
approval of ELITEK 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 
    FDA has determined that the applicable regulatory review period for 
ELITEK is 2,360 days. Of this time, 1,420 days occurred during the 
testing phase of the regulatory review period, while 940 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, 

[[Page 41510]]

and Cosmetic Act (21 U.S.C. 355(i)) became effective: January 27, 1996. 
FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on January 
27, 1996.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): December 16, 1999. FDA has verified the 
applicant's claim that the biological license application (BLA) for 
ELITEK (BLA 103946/0) was initially submitted on December 16, 1999.
    3. The date the application was approved: July 12, 2002. FDA has 
verified the applicant's claim that BLA 103946/0 was approved on July 
12, 2002.
    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 1,638 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by September 7, 2004. 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 January 
5, 2005. 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 Division of 
Dockets Management. Three copies of any mailed 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 21, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-15569 Filed 7-8-04; 8:45 am]