[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Notices]
[Pages 65211-65212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98E-0791]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Tisseel VH Kit
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 Tisseel VH Kit 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 biological product.
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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological 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 biological 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 biological product
Tisseel VH Kit. Tisseel VH Kit is indicated for use as an adjunct to
hemostasis in surgeries involving cardiopulmonary bypass and treatment
of splenic injuries due to blunt or penetrating trauma to the abdomen,
when control of bleeding by conventional surgical techniques, including
suture, ligature, and cautery is ineffective or impractical, and also
as an adjunct for the closure of colostomies. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for Tisseel VH Kit (U.S. Patent No. 4,362,567)
from Immuno Aktiengesellschaft fur chemsih-medizinshe Produkte, 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 7, 1998, FDA advised the Patent and Trademark Office that
this human biological product had undergone a regulatory review period
and that the approval of Tisseel VH Kit 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
Tisseel VH Kit is 5,065 days. Of this time, 1,203 days occurred during
the testing phase of the regulatory review
[[Page 65212]]
period, while 3,862 days occurred during the approval phase. These
periods of time were derived from the following dates:
1. The date an exemption under section 351 of the Public Health
Service Act became effective: June 20, 1984. FDA has verified the
applicant's claim that the date the investigational new drug
application became effective was on June 20, 1984.
2. The date the application was initially submitted with respect
to the human biological product under section 351 of the Public Health
Service Act: October 5, 1987. FDA has verified the applicant's claim
that the product license application (PLA) for Tisseel VH Kit (PLA 87-
0509) was initially submitted on October 5, 1987.
3. The date the application was approved: May 1, 1998. FDA has
verified the applicant's claim that PLA 87-0509 was approved on May 1,
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 1,827 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before January 25, 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 May 24, 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: November 4, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-31413 Filed 11-24-98; 8:45 am]
BILLING CODE 4160-01-F
