[Federal Register Volume 64, Number 17 (Wednesday, January 27, 1999)]
[Notices]
[Pages 4115-4116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0757]


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

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 XelodaTM 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 
Commissioner of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that human drug product.


[[Page 4116]]


ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 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 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 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 
XelodaTM (capecitabine). XelodaTM is indicated 
for the treatment of patients with metastatic breast cancer resistant 
to both paclitaxel and an anthracycline-containing chemotherapy regimen 
or resistant to paclitaxel and for whom further anthracycline therapy 
is not indicated. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for 
XelodaTM (U.S. Patent No. 4,966,891) from Hoffmann-La Roche, 
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 December 10, 1998, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of XelodaTM 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 XelodaTM is 1,410 days. Of this time, 1,228 days 
occurred during the testing phase of the regulatory review period, 
while 182 days occurred during the approval phase. These periods of 
time were derived from the following dates:
     1. The date an exemption under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act)(21 U.S.C. 355) became effective: June 
22, 1994. The applicant claims June 19, 1994, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was June 22, 1994, 
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 of the act: October 31, 
1997. The applicant claims October 28, 1997, as the date the new drug 
application (NDA) for XelodaTM (NDA 20-896) was initially 
submitted. However, FDA records indicate that NDA 20-896 was submitted 
on October 31, 1997.
     3. The date the application was approved: April 30, 1998. FDA has 
verified the applicant's claim that NDA 20-896 was approved on April 
30, 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 799 days of 
patent term extension.
     Anyone with knowledge that any of the dates as published is 
incorrect may, on or before March 29, 1999, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before July 26, 1999, 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 (address above) in three copies (except that 
individuals may submit single copies) and 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: January 18, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-1851 Filed 1-26-99; 8:45 am]
BILLING CODE 4160-01-F