[Federal Register: July 13, 2004 (Volume 69, Number 133)]
[Page 42059-42060]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0247]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for CAMPATH 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 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/dockets/ecomments.

Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 240-453-6699.

[[Page 42060]]

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 product 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 
CAMPATH (alemtuzumab). CAMPATH is indicated for the treatment of B-cell 
chronic lymphocytic leukemia (B-CLL) in patients who have been treated 
with alkylating agents and who have failed fludarabine therapy. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for CAMPATH (U.S. Patent No. 
5,545,403) from Millenium and Ilex Partners, L.P., 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 biological product had undergone a regulatory review period 
and that the approval of CAMPATH represented the first permitted 
commercial marketing or use of the product. 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 
CAMPATH is 3,423 days. Of this time, 2,921 days occurred during the 
testing phase of the regulatory review period, while 502 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 
25, 1991. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on December 
25, 1991.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act: December 23, 1999. The applicant claims December 22, 1999, 
as the date the product license application (BLA) for CAMPATH (BLA 
103948/0) was initially submitted. However, FDA records indicate that 
BLA 103948/0 was submitted on December 23, 1999.
    3. The date the application was approved: May 7, 2001. FDA has 
verified the applicant's claim that BLA 103948/0 was approved on May 7, 
    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 632 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 or electronic comments and ask for a redetermination 
by September 13, 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 
10, 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 (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 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. 04-15802 Filed 7-12-04; 8:45 am]