[Federal Register: December 2, 2003 (Volume 68, Number 231)]
[Page 67456-67457]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0153]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ELOXATIN 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 
that claims that human drug 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.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

[[Page 67457]]

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 drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug 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 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 drug product ELOXATIN 
(oxaliplatin). ELOXATIN, used in combination with infusional 5-FU/LV, 
is indicated for the treatment of patients with metastatic carcinoma of 
the colon or rectum whose disease has recurred or progressed during or 
within 6 months of completion of first line therapy with the 
combination of bolus 5-FU/LV and irinotecan. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for ELOXATIN (U.S. Patent No. 5,420,319) 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 July 16, 2003, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of ELOXATIN 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 
ELOXATIN is 3,417 days. Of this time, 3,370 days occurred during the 
testing phase of the regulatory review period, while 47 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 (the act) (21 U.S.C. 355(i)) became effective: 
April 3, 1993. The applicant claims May 2, 1997, as the date the 
investigational new drug application (IND) became effective. The date 
provided by the applicant is the date FDA released a clinical hold that 
had been placed on the application on August 16, 1993. Because that 
clinical hold was placed on the application more than 30 days after 
receipt of the IND, FDA considers the IND effective date to be April 3, 
1993, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: June 24, 2002. 
The applicant claims July 22, 1999, as the date the new drug 
application (NDA) for ELOXATIN (NDA 21-063) was initially submitted. 
However, FDA records indicate that FDA refused to file NDA 21-063, and 
this NDA was ultimately withdrawn. The applicant subsequently 
submitted, and FDA accepted for filing, a different NDA (NDA 21-492) on 
June 24, 2002. NDA 21-492 was approved for marketing on August 9, 2002.
    3. The date the application was approved: August 9, 2002. FDA has 
verified the applicant's claim that NDA 21-492 was approved on August 
9, 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 1,138 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 February 2, 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 June 1, 
2004. 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: October 30, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-29928 Filed 12-1-03; 8:45 am]