[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16062-16063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02E-0147]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; OP-1 IMPLANT

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 OP-1 IMPLANT 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 
Director 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 Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

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,

[[Page 16063]]

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 Director 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 OP-1 
IMPLANT. OP-1 IMPLANT is indicated for use as an alternative to the 
patient's own bone (autograft) in recalcitrant long bone nonunions 
where autograft is unfeasible and alternative treatments have failed. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for OP-1 IMPLANT (U.S. Patent No. 
5,258,494) from Stryker Corp., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated October 31, 2001, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of OP-1 
IMPLANT represented the first permitted commercial marketing or use of 
the product. 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 
OP-1 IMPLANT is 3,627 days. Of this time, 3,485 days occurred during 
the testing phase of the regulatory review period, while 142 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: November 14, 1991. 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 (the act) 
(21 U.S.C. 360j(g)) for human tests to begin became effective November 
14, 1991.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): May 29, 2001. 
The applicant claims May 25, 2001, as the date the premarket approval 
application (PMA) for OP-1 IMPLANT (PMA HO10002/A01) was initially 
submitted. However, FDA records indicate that PMA HO10002/A01 was 
submitted on May 29, 2001.
    3. The date the application was approved: October 17, 2001. FDA has 
verified the applicant's claim that PMA HO10002/A01 was approved on 
October 17, 2001.
    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 1,837 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may by submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by June 2, 2003. 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 September 29, 
2003. 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: February 7, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-7820 Filed 4-1-03; 8:45 am]
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