[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]
[Page 41509-41510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-99]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
period.
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,
Drug,
[[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]
BILLING CODE 4160-01-S