[Federal Register Volume 62, Number 18 (Tuesday, January 28, 1997)]
[Notices]
[Pages 4066-4067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0379]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CAMPTOSAR
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 CAMPTOSAR 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.
ADDRESSES: Written comments and petitions should be directed to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-1382.
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
[[Page 4067]]
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
CAMPTOSAR (irinotecan hydrochloride). CAMPTOSAR is
indicated for the treatment of patients with metastatic carcinoma of
the colon or rectum whose disease has recurred or progressed following
5-FU based therapy. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
CAMPTOSAR (U.S. Patent No. 4,604,463) from Kabushiki Kaisha
Yakult Honsha, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 24, 1996, FDA advised the Patent
and Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of CAMPTOSAR
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
CAMPTOSAR is 2,111 days. Of this time, 1,941 days occurred
during the testing phase of the regulatory review period, while 170
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: September
5, 1990. FDA has verified the applicant's claim that the date that the
investigational new drug application became effective was on September
5, 1990.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the Federal Food, Drug,
and Cosmetic Act: December 28, 1995. FDA has verified the applicant's
claim that the new drug application (NDA) for CAMPTOSAR (NDA
20-571) was initially submitted on December 28, 1995.
3. The date the application was approved: June 14, 1996. FDA has
verified the applicant's claim that NDA 20-571 was approved on June 14,
1996.
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 1,139 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before March 31, 1997, 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 28, 1997, 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 17, 1997.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 97-2067 Filed 1-27-97; 8:45 am]
BILLING CODE 4160-01-F
