96-21849. Determination of Regulatory Review Period for Purposes of Patent Extension; ARIMIDEXRegister  

  • [Federal Register Volume 61, Number 167 (Tuesday, August 27, 1996)]
    [Notices]
    [Pages 44069-44070]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-21849]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    [Docket No. 96E-0153]
    
    
    Determination of Regulatory Review Period for Purposes of Patent 
    Extension; ARIMIDEX
    
    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 ARIMIDEX 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, 
    12420 Parklawn Dr., rm. 1-23, 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 
    ARIMIDEX (anastrozole). ARIMIDEX is indicated for 
    the treatment of advanced breast cancer in postmenopausal women with 
    disease progression following tamoxifen therapy. Subsequent to this 
    approval, the Patent and Trademark Office received a patent term 
    restoration application for ARIMIDEX (U.S. Patent No. 
    4,935,437) from Zeneca Ltd., and the Patent and Trademark Office 
    requested FDA's assistance in determining this patent's eligibility for 
    patent term restoration. In a letter dated May 28, 1996, FDA advised 
    the Patent and Trademark Office that this human drug product had 
    undergone a regulatory review period and that the approval of 
    ARIMIDEX 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 
    ARIMIDEX is 1,336 days. Of this time, 1,062 days occurred 
    during the testing phase of the regulatory review period, while 274 
    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 (21 U.S.C. 355(i)) became effective: May 2, 
    1992. The applicant claims May 1, 1992, as the date the investigational 
    new drug application (IND) became effective. However, FDA records 
    indicate that the IND effective date was May 2, 1992, 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: March 29, 1995. FDA has verified the applicant's 
    claim that the new drug application (NDA) for ARIMIDEX (NDA 
    20-541) was initially submitted on March 29, 1995.
        3. The date the application was approved: December 27, 1995. FDA 
    has verified the applicant's claim that NDA 20-541 was approved on 
    December 27, 1995.
        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 565 days of 
    patent term extension.
        Anyone with knowledge that any of the dates as published is 
    incorrect may, on or before September 26, 1996, submit
    
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    to the Dockets Management Branch (address above) written comments and 
    ask for a redetermination. Furthermore, any interested person may 
    petition FDA, on or before February 24, 1997, 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: August 16, 1996.
    Stuart L. Nightingale,
    Associate Commissioner for Health Affairs.
    [FR Doc. 96-21849 Filed 8-26-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
08/27/1996
Department:
Health and Human Services Department
Entry Type:
Notice
Action:
Notice.
Document Number:
96-21849
Pages:
44069-44070 (2 pages)
Docket Numbers:
Docket No. 96E-0153
PDF File:
96-21849.pdf