[Federal Register Volume 67, Number 102 (Tuesday, May 28, 2002)]
[Notices]
[Pages 36897-36898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99E-1086]


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

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 ENBREL 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 comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4565.

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 Commissioner 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 
ENBREL (etanercept). ENBREL is indicated for the reduction in signs and 
symptoms of moderately to severely active rheumatoid arthritis in 
patients who have had an inadequate response to one or more disease-
modifying antirheumatic drugs. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
ENBREL (U.S. Patent No. 5,712,155) from Immunex 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 
August 7, 2000, FDA advised the Patent and Trademark Office that this 
human biological product had undergone a regulatory review period and 
that the approval of ENBREL represented the first permitted commercial 
marketing or use of the product. Shortly thereafter, the Patent and 
Trademark Office

[[Page 36898]]

requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
ENBREL is 2,322 days. Of this time, 2,143 days occurred during the 
testing phase of the regulatory review period, while 179 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: June 26, 
1992. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on June 26, 
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: May 8, 1998. The applicant claims March 9, 1998, as the 
date the product license application (BLA) for ENBREL (BLA 98-0286) was 
initially submitted. However, FDA records indicate that BLA 98-0286 was 
submitted on May 8, 1998.
    3. The date the application was approved: November 2, 1998. FDA has 
verified the applicant's claim that BLA 98-0286 was approved on 
November 2, 1998.
    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 240 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may, on or before July 29, 2002, submit to the Dockets 
Management Branch (see ADDRESSES) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before November 25, 2002, for a determination regarding whether 
the applicant for extension acted with due diligence during the 
regulatory review period. 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. Three copies of any 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: April 17, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-13227 Filed 5-24-02; 8:45 am]
BILLING CODE 4160-01-S