94-17737. Determination of Regulatory Review Period for Purposes of Patent Extension; AceonSUPTM  

  • [Federal Register Volume 59, Number 139 (Thursday, July 21, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-17737]
    
    
    [[Page Unknown]]
    
    [Federal Register: July 21, 1994]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    [Docket No. 94E-0141]
    
     
    
    Determination of Regulatory Review Period for Purposes of Patent 
    Extension; AceonTM
    
    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 AceonTM 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 
    AceonTM. AceonTM (perindopril erbumine) is indicated for the 
    treatment of patients with essential hypertension. Subsequent to this 
    approval, the Patent and Trademark Office received a patent term 
    restoration application for AceonTM (U.S. Patent No. 4,508,729) 
    from Adir, and the Patent and Trademark Office requested FDA's 
    assistance in determining this patent's eligibility for patent term 
    restoration. FDA, in a letter dated May 10, 1994, advised the Patent 
    and Trademark Office that this human drug product had undergone a 
    regulatory review period and that the approval for AceonTM 
    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 
    AceonTM is 2,284 days. Of this time, 1,367 days occurred during 
    the testing phase of the regulatory review period, while 917 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 became effective: October 1, 1987. The applicant 
    claims October 23, 1987, as the date the investigational new drug 
    application (IND) became effective. However, FDA records indicate that 
    the IND effective date was October 1, 1987, which was 30 days after FDA 
    receipt of the IND.
        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: June 28, 1991. FDA has verified the applicant's claim 
    that June 28, 1991, was the date the new drug application (NDA) for 
    AceonTM (NDA 20-184) was initially submitted.
        3. The date the application was approved: December 30, 1993. FDA 
    has verified the applicant's claim that NDA 20-184 was approved on 
    December 30, 1993.
        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 1,588 days of 
    patent extension.
        Anyone with knowledge that any of the dates as published is 
    incorrect may, on or before September 19, 1994, 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 17, 1995, 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: July 14, 1994.
     Stuart L. Nightingale,
     Associate Commissioner for Health Affairs.
    [FR Doc. 94-17737 Filed 7-20-94; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
07/21/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-17737
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: July 21, 1994, Docket No. 94E-0141