[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Page 58445-58446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0260]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for AMEVIVE and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an

[[Page 58446]]

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.

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 biologic product 
AMEVIVE (alefacept). AMEVIVE is indicated for the treatment of adult 
patients with moderate to severe chronic plaque psoriasis who are 
candidates for systemic therapy or phototherapy. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for AMEVIVE (U.S. Patent No. 5,547,853) from 
Biogen, Inc., 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 AMEVIVE 
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 
AMEVIVE is 2,104 days. Of this time, 1,618 days occurred during the 
testing phase of the regulatory review period, while 486 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 (21 U.S.C. 
355(i)): April 29, 1997. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on April 29, 1997.
    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): October 2, 2001. FDA has verified the 
applicant's claim that the biological license application (BLA) for 
Amevive (BLA 12536) was initially submitted on October 2, 2001.
    3. The date the application was approved: January 30, 2003. FDA has 
verified the applicant's claim that BLA 12536 was approved on January 
30, 2003.
    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 1,259 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 comments and ask for a redetermination by November 
29, 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 March 29, 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 
    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: August 30, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-21874 Filed 9-29-04; 8:45 am]