[Federal Register Volume 60, Number 235 (Thursday, December 7, 1995)]
[Notices]
[Pages 62866-62867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0299]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ZINECARDTM
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 ZINECARDTM 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, rm.
1-23, 12420 Parklawn Dr., 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 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
ZINECARDTM (dexrazoxane). ZINECARDTM is indicated for
reducing the incidence and severity of cardomyopathy associated with
doxorubicin administration in women with metastatic breast cancer who
have received a cumulative doxorubicin dose of 300 milligrams per
square meter and who, in their physician's opinion, would benefit from
continuing therapy with doxorubicin. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for ZINECARDTM (U.S. Patent No. 4,275,063) from
British Technology Group Ltd., 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 5, 1995, FDA advised
the Patent and Trademark Office that this human drug product had
undergone a regulatory review period and that the approval of
ZINECARDTM 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
ZINECARDTM is 2,748 days. Of this time, 1,546 days occurred during
the testing phase of the regulatory review period, while 1,202 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: November
18, 1987. The applicant claims September 25, 1987, as the date the
investigational new drug application (IND) for ZINECARDTM (IND
30,617) became effective. However, FDA records indicate that the agency
received IND 30,617 on September 22, 1987. IND 30,617 was placed on
clinical hold on October 22, 1987, and was removed from hold on
November 18, 1987. The date IND 30,617 was removed from hold, November
18, 1987, is the IND effective date.
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: February 10, 1992. The applicant claims February 7,
1992, as the date the new drug application (NDA) for ZINECARDTM
(NDA 20-212) was initially submitted. However, FDA records indicate
that FDA received NDA 20-212 on February 10, 1992, making February 10,
1992, the beginning of the NDA regulatory review period.
3. The date the application was approved: May 26, 1995. FDA has
verified the applicant's claim that NDA 20-212 was approved on May 26,
1995.
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 1,825 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before February 5, 1996, 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 June 5, 1996, 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
[[Page 62867]]
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: November 30, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-29769 Filed 12-6-95; 8:45 am]
BILLING CODE 4160-01-F
