[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Notices]
[Pages 27273-27274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0779]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; MonostrutTM Cardiac Valve Prosthesis

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 MonostrutTM Cardiac Valve 
Prosthesis 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, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration,5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

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 
MonostrutTM Cardiac Valve Prosthesis. MonostrutTM 
Cardiac Valve Prosthesis is indicated for the replacement of 
malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33 
millimeters (mm)) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm) 
heart valves. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for 
MonostrutTM Cardiac Valve Prosthesis (U.S. Patent No. 
4,343,049) from Alliance Medical Products Ltd., and the Patent and 
Trademark Office requested FDA's assistance in determining this

[[Page 27274]]

patent's eligibility for patent term restoration. In a letter dated 
September 29, 1998, FDA advised the Patent and Trademark Office that 
this medical device had undergone a regulatory review period, and that 
the approval of MonostrutTM Cardiac Valve Prosthesis 
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 
MonostrutTM Cardiac Valve Prosthesis is 5,620 days. Of this 
time, 1,729 days occurred during the testing phase of the regulatory 
review period, while 3,891 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: May 14, 1982. FDA has verified the applicant's claim that the 
date the investigational device exemption 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 May 14, 1982.

    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 5, 
1987. The applicant claims May 8, 1986, as the date the premarket 
approval application (PMA) for MonostrutTM Cardiac Valve 
Prosthesis (PMA P970002) was initially submitted. However, FDA records 
indicate that PMA P970002 was submitted on February 5, 1987.

    3. The date the application was approved: September 30, 1997. FDA 
has verified the applicant's claim that PMA P970002 was approved on 
September 30, 1997.

    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 730 days of 
patent term extension.

    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before July 19, 1999, 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 November 15, 1999, 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: May 4, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-12528 Filed 5-18-99; 8:45 am]
BILLING CODE 4160-01-F