[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
