98-31413. Determination of Regulatory Review Period for Purposes of Patent Extension; Tisseel VH Kit  

  • [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
    
    
    

Document Information

Published:
11/25/1998
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
98-31413
Pages:
65211-65212 (2 pages)
Docket Numbers:
Docket No. 98E-0791
PDF File:
98-31413.pdf