[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