[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29336-29337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10127]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0495]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; KDR 401 and 403 PACEMAKERS

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for KDR 401 and 403 PACEMAKERS 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 those medical devices.

ADDRESSES: Submit written comments and petitions to the Division of 
Dockets Management (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: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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

[[Page 29337]]

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 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 approved for marketing the medical devices, KDR 401 and 403 
PACEMAKERS. KDR 401 and 403 PACEMAKERS are indicated for the following: 
Rate adaptive pacing in patients who may benefit from increased pacing 
rates concurrent with increases in activity and/or minute ventilation; 
accepted patient conditions warranting chronic cardiac pacing which 
include: symptomatic paroxysmal or permanent second or third-degree 
atrioventricular (AV) block; Symptomatic bilateral bundle branch block; 
symptomatic paroxysmal or transient sinus node dysfunctions with or 
without associated AV conduction disorders; bradycardia-tachycardia 
syndrome to prevent symptomatic bradycardia or some forms of 
symptomatic tachyarrhythmias; and vasovagal syndromes or hypersensitive 
carotid sinus syndromes. KDR 401 and 403 PACEMAKERS are also indicated 
for dual chamber and atrial tracking modes in patients who may benefit 
from maintenance of AV synchrony. Dual chamber modes are specifically 
indicated for treatment of conduction disorders that require 
restoration of both rate and AV synchrony, which include: Various 
degrees of AV block to maintain the atrial contribution to cardiac 
output and vasovagal intolerance in the presence of persistent sinus 
rhythm. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for KDR 401 and 403 
PACEMAKERS (U.S. Patent No. 4,958,632) from Medtronic, 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 February 22, 2007, FDA advised the Patent and Trademark Office 
that these medical devices had undergone a regulatory review period and 
that the approval of KDR 401 and 403 PACEMAKERS represented the first 
permitted commercial marketing or use of the products. Thereafter, the 
Patent and Trademark Office requested that FDA determine the products' 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
KDR 401 and 403 PACEMAKERS is 716 days. Of this time, 358 days occurred 
during the testing phase of the regulatory review period, while 358 
days occurred during the approval phase. These periods of time were 
derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this 
device became effective: February 16, 1996. The applicant claims that 
the investigational device exemption (IDE) required under section 
520(g) of the act for human tests to begin became effective on May 21, 
1997. However, FDA records indicate that the IDE was determined 
substantially complete for clinical studies to have begun on February 
16, 1996, 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): February 7, 
1997. The applicant claims February 6, 1997, as the date the premarket 
approval application (PMA) for KDR 401 and 403 PACEMAKERS (PMA 970012) 
was initially submitted. However, FDA records indicate that PMA 970012 
was submitted on February 7, 1997.
    3. The date the application was approved: January 30, 1998. FDA has 
verified the applicant's claim that PMA 970012 was approved on January 
30, 1998.
    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 358 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by July 24, 2007. 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 November 21, 
2007. 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 Division of 
Dockets Management. Three copies of any mailed 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-10127 Filed 5-24-07; 8:45 am]
BILLING CODE 4160-01-S