[Federal Register Volume 63, Number 217 (Tuesday, November 10, 1998)]
[Notices]
[Pages 63066-63067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0228]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Neuro Cybernetic Prosthesis (NCP) 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 Neuro Cybernetic Prosthesis 
(NCP) 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, 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 Neuro 
Cybernetic Prosthesis (NCP) System. Neuro Cybernetic 
Prosthesis (NCP) System is indicated for use as an adjunctive 
therapy in reducing the frequency of seizures in adults and adolescents 
over 12 years of age with partial onset seizures, which are refractory 
to antiepileptic medications. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
Neuro Cybernetic Prosthesis (NCP) System (U.S. Patent No. 
4,867,164) from Cyberonics, 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 22, 1998, FDA advised 
the Patent and Trademark Office that this medical device had undergone 
a regulatory review period and that the approval of Neuro Cybernetic 
Prosthesis (NCP) System 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 
Neuro Cybernetic Prosthesis (NCP) System is 3,237 days. Of 
this time, 3,066 days occurred during the testing phase of the 
regulatory review period, while 171 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 6, 1988. 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, 1988. However, FDA 
records indicate that the IDE was determined substantially complete for 
clinical studies to have begun on September 6, 1988, 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): January 27, 
1997. The applicant claims December 16, 1991, as the date the premarket 
approval application (PMA) for Neuro Cybernetic Prosthesis 
(NCP) System (PMA 910070) was initially submitted. However, 
FDA records indicate that PMA 910070 submitted on December 6, 1991, was 
incomplete. FDA refused this application and notified the applicant of 
this fact by letter dated February 11, 1992. The completed PMA was then 
submitted and renumbered PMA 970003 on January 27, 1997, which is 
considered to be the PMA initially submitted date.
    3.  The date the application was approved: July 16, 1997. FDA has 
verified the applicant's claim that PMA 970003 was approved on July 16, 
1997.
    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 1,761 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before January 11, 1999, 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 May 10, 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

[[Page 63067]]

(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: November 2, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-30005 Filed 11-9-98; 8:45 am]
BILLING CODE 4160-01-F