[Federal Register Volume 65, Number 20 (Monday, January 31, 2000)]
[Unknown Section]
[Pages 4616-4617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2032]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99E-1115]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Lumbar I/F Cage

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 Lumbar I/F Cage 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:  Claudia V. Grillo, Regulatory Policy 
Staff (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

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, 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 Lumbar I/F 
Cage. Lumbar I/F Cage is indicated for an open 
posterior approach using autogenous bone graft in patients with 
degenerative disc disease at one or two spinal levels from L2-S1 whose 
condition requires the use of interbody fusion combined with 
posterolateral fusion and posterior pedicle screw fixation. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for Lumbar I/F Cage (U.S. Patent 
No. 4,834,757) from DePuy AcroMed, 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 May 10, 
1999, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of Lumbar I/F Cage 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 
Lumbar I/F Cage is 2,631 days. Of this time, 1,708 days 
occurred during the testing phase of the regulatory review period, 
while 923 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 22, 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 
22, 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): July 25, 
1996. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for Lumbar I/F Cage (PMA P960025) 
was initially submitted July 25, 1996.
    3. The date the application was approved: February 2, 1999. FDA has 
verified the applicant's claim that PMA P960025 was approved on 
February 2, 1999.
    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 1,776 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before March 31, 2000, 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 July 31, 2000, 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

[[Page 4617]]

(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: December 23, 1999.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 00-2032 Filed 1-28-00; 8:45 am]
BILLING CODE 4160-01-F