[Federal Register Volume 60, Number 235 (Thursday, December 7, 1995)]
[Notices]
[Page 62867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29766]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0183]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CPI<Register> Ventak<Register> P2 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<Register> Ventak<Register> P2 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<Register> Ventak<Register> P2 AICD System. CPI<Register> 
Ventak<Register> P2 AICD System is indicated for the treatment of 
patients with ventricular fibrillation and/or ventricular 
tachyarrhythmia 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<Register> Ventak<Register> 
P2 AICD System (U.S. Patent No. Re. 34,879) from Cardiac Pacemakers, 
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 September 25, 1995, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of CPI<Register> Ventak<Register> P2 AICD 
System represented the first commercial marketing 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 
CPI<Register> Ventak<Register> P2 AICD System is 1,178 days. Of this 
time, 620 days occurred during the testing phase of the regulatory 
review period, while 558 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: December 20, 1991. 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 (21 U.S.C. 
360j(g)) for human tests to begin became effective on December 20, 
1991.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e): August 30, 1993. FDA has verified the applicant's 
claim that the premarket approval application (PMA) for CPI<Register> 
Ventak<Register> P2 AICD Systems (PMA P930035) was initially submitted 
on August 30, 1993.
    3. The date the application was approved: March 10, 1995. FDA has 
verified the applicant's claim that PMA P930035 was approved on March 
10, 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 363 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before February 5, 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 June 5, 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: November 30, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-29766 Filed 12-6-95; 8:45 am]
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