[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
