[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Notices]
[Pages 19547-19548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9694]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02E-0343]


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

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 ZEVALIN 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 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
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, 301-827-3460.

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

[[Page 19548]]

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 
ZEVALIN (CD20 Monoclonal Antibody). ZEVALIN is indicated for treatment 
of patients with relapsed or refractory low-grade, follicular, or 
transformed B-cell non-Hodgkin's lymphoma, including patients with 
Rituximab (Rituxan) refractory follicular non-Hodgkin's lymphoma; the 
therapeutic regimen includes Rituximab, Indium-111 Ibritumomab 
Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for ZEVALIN (U.S. Patent No. 5,776,456) from 
IDEC Pharmaceuticals Corp., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated February 3, 2003, FDA 
advised the Patent and Trademark Office that this human biological 
product had undergone a regulatory review period and that the approval 
of ZEVALIN 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 
ZEVALIN is 3,363 days. Of this time, 2,887 days occurred during the 
testing phase of the regulatory review period, while 476 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: December 7, 
1992. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on December 
7, 1992.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (41 U.S.C. 262): November 1, 2000. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
ZEVALIN (BLA 1250190) was initially submitted on November 1, 2000.
    3. The date the application was approved: February 19, 2002. FDA 
has verified the applicant's claim that BLA 1250190 was approved on 
February 19, 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 227 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments and ask for a redetermination by June 
20, 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 October 20, 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 (see ADDRESSES). 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 31, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-9694 Filed 4-21-03; 8:45 am]
BILLING CODE 4160-01-S