97-2064. Determination of Regulatory Review Period for Purposes of Patent Extension; DIFFERIN Topical Gel  

  • [Federal Register Volume 62, Number 18 (Tuesday, January 28, 1997)]
    [Notices]
    [Page 4064]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-2064]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    [Docket No. 96E-0355]
    
    
    Determination of Regulatory Review Period for Purposes of Patent 
    Extension; DIFFERIN Topical Gel
    
    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 DIFFERIN Topical Gel 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 DIFFERIN 
    Topical Gel (adapalene). DIFFERIN Topical Gel is indicated for the 
    topical treatment of acne vulgaris. Subsequent to this approval, the 
    Patent and Trademark Office received a patent term restoration 
    application for DIFFERIN Topical Gel (U.S. Patent No. 5,212,303) from 
    Centre International de Recherches Dermatologiques (CIRD), 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 24, 1996, FDA advised the Patent and Trademark Office 
    that this human drug product had undergone a regulatory review period 
    and that the approval of DIFFERIN Topical Gel 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 
    DIFFERIN Topical Gel is 2,447 days. Of this time, 1,401 days occurred 
    during the testing phase of the regulatory review period, while 1,046 
    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: September 
    20, 1989. FDA has verified the applicant's claim that the date that the 
    investigational new drug application became effective was on September 
    20, 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: July 21, 1993. The applicant claims July 15, 1993, as 
    the date the new drug application (NDA) for DIFFERIN Topical Gel (NDA 
    20-380) was initially submitted. However, FDA records indicate that NDA 
    20-380 was submitted on July 21, 1993.
        3. The date the application was approved: May 31, 1996. FDA has 
    verified the applicant's claim that NDA 20-380 was approved on May 31, 
    1996.
        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 13 days of 
    patent term extension.
        Anyone with knowledge that any of the dates as published is 
    incorrect may, on or before March 31, 1997, 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 July 28, 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: January 17, 1997.
    Stuart L. Nightingale,
    Associate Commissioner for Health Affairs.
    [FR Doc. 97-2064 Filed 1-27-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
01/28/1997
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-2064
Pages:
4064-4064 (1 pages)
Docket Numbers:
Docket No. 96E-0355
PDF File:
97-2064.pdf