[Federal Register Volume 60, Number 41 (Thursday, March 2, 1995)]
[Notices]
[Pages 11671-11672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5183]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94E-0360]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Albunex

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for Albunex 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 [[Page 11672]] 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 
Albunex. Albunex is indicated as an aid for 
ultrasound contrast enhancement of ventricular chambers and improvement 
of endocardial border definition in patients with suboptimal echoes 
undergoing ventricular function and regional wall motion studies. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Albunex (U.S. Patent 
No. 4,844,882) from Molecular Biosystems, 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 
December 19, 1994, FDA advised the Patent and Trademark Office that 
this medical device had undergone a regulatory review period and that 
the approval of Albunex 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 
Albunex is 2,397 days. Of this time, 975 days occurred during 
the testing phase of the regulatory review period, while 1,422 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 14, 1988. The applicant claims that 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 August 18, 1987. However, FDA records 
indicate that IDE was conditionally approved on January 14, 1988, which 
represents the IDE effective date.
    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): September 14, 1990. The applicant claims 
September 11, 1990, as the date the premarket approval application 
(PMA) for Albunex (PMA P900059) was initially submitted. 
However, FDA records indicate that PMA P900059 was submitted on 
September 14, 1990.
    3. The date the application was approved: August 5, 1994. FDA has 
verified the applicant's claim that PMA P900059 was approved on August 
5, 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 763 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before May 1, 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 August 29, 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. 41-42, 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: February 24, 1995.
Allen B. Duncan,
Acting Associate Commissioner for Health Affairs.
[FR Doc. 95-5183 Filed 3-1-95; 8:45 am]
BILLING CODE 4160-01-F