[Federal Register Volume 61, Number 155 (Friday, August 9, 1996)]
[Notices]
[Pages 41637-41638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0114]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CORVERT

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 CORVERT 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

[[Page 41638]]

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 CORVERT 
(ibutilide fumarate). CORVERT is indicated for the rapid conversion of 
atrial fibrillation or atrial flutter of recent onset to sinus rhythm. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for CORVERT (U.S. Patent No. 
5,155,268) from the Upjohn 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 May 13, 1996, FDA advised 
the Patent and Trademark Office that this human drug product had 
undergone a regulatory review period and that the approval of CORVERT 
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 
CORVERT is 2,292 days. Of this time, 1,865 days occurred during the 
testing phase of the regulatory review period, while 427 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 the 
investigational new drug application (IND) 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: October 28, 1994. FDA has verified the 
applicant's claim that the new drug application (NDA) for CORVERT (NDA 
20-491) was initially submitted on October 28, 1994.
    -3. The date the application was approved: December 28, 1995. The 
applicant claims December 29, 1995, as the date NDA 20-491 was 
approved. However, FDA records indicate that NDA 20-491 was approved on 
December 28, 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 application seeks 73 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 8, 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 Februar 6, 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: July 26, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-20342 Filed 8-8-96; 8:45 am]
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