96-12093. Determination of Regulatory Review Period for Purposes of Patent Extension; TRUSOPTRegister  

  • [Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
    [Notices]
    [Pages 24317-24318]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-12093]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    [Docket No. 95E-0408]
    
    
    Determination of Regulatory Review Period for Purposes of Patent 
    Extension; TRUSOPT
    
    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 TRUSOPT 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 
    TRUSOPT (dorzolamide hydrochloride). TRUSOPT is 
    indicated in the treatment for elevated intraocular pressure in 
    patients with ocular hypertension or open-angle glaucoma. Subsequent to 
    this approval, the Patent and Trademark Office received a patent term 
    restoration application for TRUSOPT (U.S. Patent No. 
    4,797,413) from Merck & Co., Inc., and the Patent and Trademark Office 
    requested FDA's assistance in determining this patent's eligibility for 
    patent term restoration. In a letter dated January 26, 1996, FDA 
    advised the Patent and Trademark Office that this human drug product 
    had undergone a regulatory review period and that the approval of 
    TRUSOPT 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 
    TRUSOPT is 2,101 days. Of this time, 1,736 days occurred 
    during the testing phase of the regulatory review period, while 365 
    days occurred during the approval phase. These periods of time were 
    derived from the following dates:
    
    [[Page 24318]]
    
        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: March 11, 
    1989. FDA has verified the applicant's claim that the date that the 
    investigational new drug application (IND) became effective was March 
    11, 1989.
        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: December 10, 1993. FDA has verified the applicant's 
    claim that the new drug application (NDA) for TRUSOPT (NDA 
    20-408) was initially submitted on December 10, 1993.
        3. The date the application was approved: December 9, 1994. FDA has 
    verified the applicant's claim that NDA 20-408 was approved on December 
    9, 1994.
        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 1,232 days of 
    patent term extension.
        Anyone with knowledge that any of the dates as published is 
    incorrect may, on or before July 15, 1996, 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 November 12, 1996, 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: April 26, 1996.
    Stuart L. Nightingale,
    Associate Commissioner for Health Affairs.
    [FR Doc. 96-12093 Filed 5-13-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Published:
05/14/1996
Department:
Health and Human Services Department
Entry Type:
Notice
Action:
Notice.
Document Number:
96-12093
Pages:
24317-24318 (2 pages)
Docket Numbers:
Docket No. 95E-0408
PDF File:
96-12093.pdf