[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Notices]
[Pages 24316-24317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12092]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0043]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; EPIVIR<SUP>TM

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 EPIVIR<SUP>TM and is publishing this 
notice of that determination as required by law. FDA has made the 
determination because of the submission of an application of 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 
EPIVIR<SUP>TM (lamivudine). EPIVIR<SUP>TM in combination with 
Retrovir<Register> (zidovudine) is indicated for the treatment of human 
immunodeficiency virus infection when therapy is warranted based on 
clinical and/or immunological evidence of disease progression. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for EPIVIR<SUP>TM (U.S. Patent No. 
5,047,407) from Glaxo Wellcome, 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 March 1, 
1996, FDA advised the Patent and Trademark Office that this human

[[Page 24317]]

drug product had undergone a regulatory review period that the approval 
of EPIVIR<SUP>TM 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 
EPIVIR<SUP>TM is 1,582 days. Of this time, 1,448 days occurred during 
the testing phase of the regulatory review period, while 134 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: July 21, 
1991. The applicant claims July 24, 1991, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 21, 1991, 
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: July 7, 1995. The applicant claims June 29, 1995, as 
the date the new drug application (NDA's) for EPIVIR<SUP>TM (NDA's 20-
564 and 20-596) were initially submitted. However, FDA records indicate 
that NDA's 20-564 and 20-596 were submitted on July 7, 1995 (the date 
the User Fee checks were received by the agency). Both NDA's were 
originally received by the agency on June 30, 1995, unaccompanied by 
the appropriate User Fee checks. Review of a NDA does not begin until 
the correct amount of User Fee money has been received by the agency 
from the sponsor of the NDA.
    3. The date the application was approved: November 17, 1995. FDA 
has verified the applicants's claim that NDA's 20-564 and 20-596 were 
approved on November 17, 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 836 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. 96-12092 Filed 5-13-96; 8:45 am]
BILLING CODE 4160-01-F