[Federal Register: November 25, 2003 (Volume 68, Number 227)]
[Notices]
[Page 66112-66113]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25no03-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
FOR FURTHER INFORMATION CONTACT: Claudia V. 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
[[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
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: 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]
BILLING CODE 4160-01-S