[Federal Register Volume 68, Number 56 (Monday, March 24, 2003)]
[Notices]
[Pages 14244-14245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02E-0149]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; GENESIS NEUROSTIMULATION 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 GENESIS NEUROSTIMULATION 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 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

[[Page 14245]]

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 recently approved for marketing the medical device GENESIS 
NEUROSTIMULATION SYSTEM. GENESIS NEUROSTIMULATION SYSTEM is indicated 
as an aid in the management of chronic, intractable pain of the trunk 
and/or limbs, including unilateral or bilateral pain associated with 
failed back surgery syndrome, intractable low back pain, and leg pain. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for GENESIS NEUROSTIMULATION SYSTEM 
(U.S. Patent No. 4,793,353) from Advanced Neuromodulation Systems, 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, 2002, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of GENESIS NEUROSTIMULATION SYSTEM 
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 
GENESIS NEUROSTIMULATION SYSTEM is 469 days. Of this time, 292 days 
occurred during the testing phase of the regulatory review period, 
while 177 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: August 11, 2000. 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 June 16, 1999. However, FDA records 
indicate that the IDE was determined substantially complete for 
clinical studies to have begun on August 11, 2000, 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): May 29, 2001. 
The applicant claims April 3, 2001, as the date the premarket approval 
application (PMA) for GENESIS NEUROSTIMULATION SYSTEM (PMA P010032) was 
initially submitted. However, FDA records indicate that PMA P010032 was 
submitted on May 29, 2001.
    3. The date the application was approved: November 21, 2001. FDA 
has verified the applicant's claim that PMA P010032 was approved on 
November 21, 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 840 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments and ask for a redetermination by May 23, 
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 22, 
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 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. 03-6892 Filed 3-21-03; 8:45 am]
BILLING CODE 4160-01-S