[Federal Register: November 25, 2003 (Volume 68, Number 227)]
[Page 66112-66113]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2002E-0099, 2002E-0184, and 2003E-0255]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for XIGRIS and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of three applications to the Director of 
Patents and Trademarks, Department of Commerce, for the extension of 
three patents which claim that human biological product.

ADDRESSES: Submit written 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.

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

[[Page 66113]]

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 human biological 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 
XIGRIS (droctrecogin alpha). XIGRIS is indicated for the reduction of 
mortality in adult patients with severe sepsis (sepsis associated with 
severe organ dysfunction) who have a high risk of death. Subsequent to 
this approval, the Patent and Trademark Office received three patent 
term restoration applications for XIGRIS (U.S. Patent Nos. 4,775,624; 
5,681,932; and 5,270,040) from Eli Lilly & Co., and the Patent and 
Trademark Office requested FDA's assistance in determining these 
patents' eligibility for patent term restoration. In a letter dated 
December 30, 2002, FDA advised the Patent and Trademark Office that 
this human biological product had undergone a regulatory review period 
and that the approval of XIGRIS 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 
XIGRIS is 2,493 days. Of this time, 2,193 days occurred during the 
testing phase of the regulatory review period, while 300 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: January 26, 
1995. The applicant claims January 25, 1995, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was January 26, 1995, 
which was 30 days after FDA receipt of the IND.
    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): January 26, 2001. FDA has verified the 
applicant's claim that the biological license application (BLA) for 
XIGRIS (BLA 125029/0) was initially submitted on January 26, 2001.
    3. The date the application was approved: November 21, 2001. FDA 
has verified the applicant's claim that BLA 125029/0 was approved on 
November 21, 2001.
    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 1,397 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written comments and ask for a redetermination by January 
26, 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 May 24, 2004. 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 
    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: October 30, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-29333 Filed 11-24-03; 8:45 am]