[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Notices]
[Pages 41263-41264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96E-0314]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; GEMZAR<Register>

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 GEMZAR<Register> 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, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

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

[[Page 41264]]

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 
GEMZAR<Register> (gemcitabine hydrochloride). GEMZAR<Register> is 
indicated for use as a firstline treatment for patients with locally 
advanced (nonresectable stage II or stage III) or metastatic (stage IV) 
adenocarcinoma of the pancreas in patients previously treated with 5-
FU. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for GEMZAR<Register> 
(U.S. Patent No. 4,808,614) from Eli Lilly & Co., 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 7, 1997, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of GEMZAR<Register> 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 
GEMZAR<Register> is 3,293 days. Of this time, 2,824 days occurred 
during the testing phase of the regulatory review period, 469 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 (the act) (21 U.S.C. 355(i)) became effective: 
May 12, 1987. The applicant claims June 18, 1987, as the date the 
investigational new drug application (IND) for GEMZAR<Register> became 
effective. However, FDA records indicate that the IND effective date 
was May 12, 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 act: February 2, 
1995. FDA has verified the applicant's claim that the new drug 
application (NDA) for GEMZAR<Register> (NDA 20-509) was initially 
submitted on February 2, 1995.
    3. The date the application was approved: May 15, 1996. FDA has 
verified the applicant's claim that NDA 20-509 was approved on May 15, 
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 1,537 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 2, 1998, 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 February 1, 1999, 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 8, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-20593 Filed 7-31-98; 8:45 am]
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