[Federal Register Volume 62, Number 146 (Wednesday, July 30, 1997)]
[Notices]
[Pages 40829-40830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0502]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; BAK<SUP>TM</SUP> Interbody Fusion System

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 BAK<SUP>TM</SUP> Interbody Fusion System 
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, 
12420 Parklawn Dr., rm. 1-23, 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 
BAK<SUP>TM</SUP> Interbody Fusion System. BAK<SUP>TM</SUP> Interbody 
Fusion System is indicated for use with autogenous bone graft in 
patients with degenerative disc disease (DDD) at one or two contiguous 
levels from L2-S1. These DDD patients may also have up to Grade I 
spondylolisthesis or retrolisthesis at the involved level(s). 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for BAK<SUP>TM</SUP> Interbody 
Fusion System (U.S. Patent No. 5,015,247) from Karlin Technology, 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 March 12, 1997, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of BAK<SUP>TM</SUP> Interbody Fusion 
System 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 
BAK<SUP>TM</SUP> Interbody Fusion System is 1,731 days. Of this time, 
1,341 days occurred during the testing phase of the regulatory review 
period, while 390 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: December 27, 1991. 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 April 30, 1992. However, FDA records indicate 
that the IDE for clinical studies of the BAK<SUP>TM</SUP> Interbody 
Fusion System was approved on December 27, 1991, 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): August 28, 1995. The applicant claims January 17, 
1995, as the date the premarket approval application (PMA) for 
BAK<SUP>TM</SUP> Interbody Fusion System (PMA P950002) was initially 
submitted. FDA records confirm that an incomplete PMA P950002 was 
received on January 17, 1995. PMA P950002 was amended a number of times 
and was determined to be adequate for filing based on a submission 
received on August 28, 1995, which is considered the initially 
submitted date for the PMA.
    3. The date the application was approved: September 20, 1996. FDA 
has verified the applicant's claim that PMA P950002 was approved on 
September 20, 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,

[[Page 40830]]

this applicant seeks 829 days of patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before September 29, 1997, 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 January 27, 1998, 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: July 15, 1997.
Allen B. Duncan,
Acting Associate Commissioner for Health Affairs.
[FR Doc. 97-19984 Filed 7-29-97; 8:45 am]
BILLING CODE 4160-01-F