[Federal Register Volume 67, Number 13 (Friday, January 18, 2002)]
[Notices]
[Page 2663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1320]



[[Page 2663]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99E-0117]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Heart Laser 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 the Heart Laser 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: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 Heart Laser 
System. Transmyocardial revascularization with the Heart Laser System 
is indicated for the treatment of patients with stable angina 
refractory to medical treatment and secondary to objectively 
demonstrated coronary artery atherosclerosis not amenable to direct 
coronary revascularization. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for the 
Heart Laser System (U.S. Patent No. 5,125,926) from PLC Medical 
Systems, 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 March 16, 1999, FDA advised the Patent 
and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of the Heart Laser 
System represented the first permitted commercial marketing or use of 
the product. Subsequently, 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 
the Heart Laser System is 3,135 days. Of this time, 2,586 days occurred 
during the testing phase of the regulatory review period, while 549 
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: January 21, 1990. The applicant claims that 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 30, 1990. However, FDA 
records indicate that the IDE was determined substantially complete for 
clinical studies to have begun on January 21, 1990, which represents 
the IDE effective date.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): February 18, 
1997. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for the Heart Laser System (PMA P950015) was 
initially submitted February 18, 1997.
    3. The date the application was approved: August 20, 1998. FDA has 
verified the applicant's claim that PMA P950015 was approved on August 
20, 1998.
    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 695 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (address above) 
written comments and ask for a redetermination by March 19, 2002. 
Furthermore, any interested person may petition FDA for a determination 
regarding whether the applicant for extension acted with due diligence 
during the regulatory review period by July 17, 2002. 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. Three copies of any information are to be submitted, 
except that individuals may submit one copy. Comments are to be 
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: September 28, 2001.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-1320 Filed 1-17-02; 8:45 am]
BILLING CODE 4160-01-S