[Federal Register Volume 60, Number 78 (Monday, April 24, 1995)]
[Notices]
[Pages 20107-20108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10076]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0012]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Sonic Accelerated Fracture Healing System (SAFHS<Register>)

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 SAFHS<Register> 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 
SAFHS<Register>. SAFHS<Register> is indicated for the acceleration of 
the time to a healed fracture for fresh, closed, distal radius 
(Colle's) fractures and fresh, closed or Grade I open tibial diaphysis 
fractures in skeletally mature individuals when these fractures are 
orthopedically managed by closed reduction and cast immobilization. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for SAFHS<Register> (U.S Patent No. 
4,530,360) from Exogen, Inc., and the Patent and 
[[Page 20108]] Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated February 21, 1995, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of SAFHS<Register> 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 
SAFHS<Register> is 3,073 days. Of this time, 1,532 days occurred during 
the testing phase of the regulatory review period, while 1,541 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 9, 1986. 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 May 9, 1986.
    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): July 18, 1990. FDA has verified the applicant's 
claim that the premarket approval application (PMA) for SAFHS<Register> 
(PMA P90009) was initially submitted on July 18, 1990.
    3. The date the application was approved: October 5, 1994. FDA has 
verified the applicant's claim that PMA P90009 was approved on October 
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 1,825 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before June 23, 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 October 23, 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: April 17, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-10076 Filed 4-21-95; 8:45 am]
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