[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
