98-18407. Determination of Regulatory Review Period for Purposes of Patent Extension; FlowmaxSUPTM/SUP  

  • [Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
    [Notices]
    [Pages 37399-37400]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-18407]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 97E-0359]
    
    
    Determination of Regulatory Review Period for Purposes of Patent 
    Extension; FlowmaxTM
    
    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 FlowmaxTM 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, 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 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 
    FlowmaxTM (tamsulosin hydrochloride). FlowmaxTM 
    is indicated for the treatment of the signs and symptoms of benign 
    prostatic hyperplasia (BPH). Subsequent to this approval, the Patent 
    and Trademark Office received a patent term restoration application for 
    FlowmaxTM (U.S. Patent No. 4,868,216) from Yamanouchi 
    Pharmaceutical, and the Patent and Trademark Office requested FDA's 
    assistance in determining this patent's eligibility for patent term 
    restoration. In a letter dated November 7, 1997, FDA advised the Patent 
    and Trademark Office that this human drug product had undergone a 
    regulatory review period and that the approval of FlowmaxTM 
    represented the first permitted commercial marketing or use of the 
    product. Shortly thereafter, the Patent and Trademark Office requested 
    that the FDA determine the product's regulatory review period.
        FDA has determined that the applicable regulatory review period for 
    FlowmaxTM is 3,529 days. Of this time, 3,163 days occurred 
    during the testing phase of the regulatory review period, 366 days 
    occurred during the approval phase. These periods of time were derived 
    from the following dates:
         1.  The date an exemption under section 505 of the Federal Food, 
    Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: 
    August 19, 1987. FDA has verified the applicant's claim that the date 
    the investigational new
    
    [[Page 37400]]
    
    drug application became effective was on August 19, 1987.
        2.  The date the application was initially submitted with respect 
    to the human drug product under section 505 of the act: April 15, 1996. 
    FDA has verified the applicant's claim that the new drug application 
    (NDA) for FlowmaxTM (NDA 20-579) was initially submitted on 
    April 15, 1996.
        3.  The date the application was approved: April 15, 1997. FDA has 
    verified the applicant's claim that NDA 20-579 was approved on April 
    15, 1997.
        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 1,669 days of 
    patent term extension.
        Anyone with knowledge that any of the dates as published is 
    incorrect may, on or before September 8, 1998, 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 January 6, 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: June 23, 1998.
    Thomas J. McGinnis,
    Deputy Associate Commissioner for Health Affairs.
    [FR Doc. 98-18407 Filed 7-9-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
07/10/1998
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
98-18407
Pages:
37399-37400 (2 pages)
Docket Numbers:
Docket No. 97E-0359
PDF File:
98-18407.pdf