[Federal Register Volume 63, Number 197 (Tuesday, October 13, 1998)]
[Notices]
[Pages 54719-54720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0087]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Ray Threaded Fusion CageTM

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 Ray Threaded Fusion CageTM 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 Ray Threaded 
Fusion CageTM. Ray Threaded Fusion CageTM is 
indicated for use with autogenous bone graft in patients with 
degenerative disk disease (DDD) at one or two levels from L2 to S1. 
These DDD patients may also have up to Grade 1 spondylolisthesis at the 
involved level(s). Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for Ray 
Threaded Fusion CageTM (U.S. Patent No. 4,961,740) from 
United States Surgical 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 April 11, 1997, FDA advised 
the Patent and Trademark Office that this medical device had undergone 
a regulatory review period and that the approval of Ray Threaded Fusion 
CageTM 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 
Ray Threaded Fusion CageTM is 1,861 days. Of this time, 
1,357 days occurred during the testing phase of the regulatory review 
period, while 504 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: September 27, 1991. The applicant claims that 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 on November 15, 1991. 
However, FDA records indicate that the IDE was determined substantially 
complete for clinical studies to have begun on September 27, 1991, 
which represents the IDE effective date.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): June 14, 
1995. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for Ray Threaded Fusion CageTM 
(PMA P950019) was initially submitted June 14, 1995.
    3. The date the application was approved: October 29, 1996. FDA has 
verified the applicant's claim that PMA P950019 was approved on October 
29, 1996.
    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 742 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before December 14, 1998, 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 April 12, 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

[[Page 54720]]

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: September 28, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-27284 Filed 10-9-98; 8:45 am]
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