[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

[[Page 44070]]

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]
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