[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28064]


[[Page Unknown]]

[Federal Register: November 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94E-0315]

 

Determination of Regulatory Review Period for Purposes of Patent 
Extension; CPI Ventak PRx AICD System

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 CPI Ventak 
PRx AICD System 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 medical device.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., 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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. 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 
(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 medical device will include 
all of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA recently approved for marketing the medical device 
CPI Ventak PRx AICD System. CPI 
Ventak PRx AICD System is indicated for the 
treatment of patients with ventricular fibrillation and/or ventricular 
tachyarrhythmias who are at high risk of sudden cardiac death. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for CPI Ventak 
PRx AICD System (U.S. Patent No. 4,407,288) from Cardiac 
Pacemakers, Inc., and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. FDA, in a letter dated September 21, 1994, advised the 
Patent and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of CPI 
Ventak PRx AICD System represented the first 
commercial marketing of the product. Shortly thereafter, the Patent and 
Trademark Office requested that the FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
CPI Ventak PRx AICD System is 1,306 days. 
Of this time, 398 days occurred during the testing phase of the 
regulatory review period, while 908 days occurred during the approval 
phase. These periods of time were derived from the following dates:
    1. The date a clinical investigation involving this device was 
begun: November 21, 1990. FDA has verified the applicant's claim that 
the date the investigational device exemption (IDE) required under 
section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360j(g)) for human tests to begin became effective on 
November 21, 1990.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): December 23, 
1991. The applicant claims December 20, 1991, as the date the premarket 
approval application (PMA) for CPI Ventak 
PRx AICD (PMA P910077) was initially submitted. However, FDA 
records indicate that PMA P910077 was submitted on December 23, 1991.
    3. The date the application was approved: June 17, 1994. FDA has 
verified the applicant's claim that PMA P910077 was approved on June 
17, 1994.
    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 394 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before January 17, 1995, 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 May 15, 1995, 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. 41-2, 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: November 3, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-28064 Filed 11-14-94; 8:45 am]
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