Determination of Regulatory Review Period for Purposes of Patent Extension; Ray Threaded Fusion CageSUPTM/SUP

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0087]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Ray Threaded Fusion CageTM

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 Ray Threaded Fusion CageTM 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 Ray Threaded

Fusion CageTM. Ray Threaded Fusion CageTM is

indicated for use with autogenous bone graft in patients with

degenerative disk disease (DDD) at one or two levels from L2 to S1.

These DDD patients may also have up to Grade 1 spondylolisthesis at the

involved level(s). Subsequent to this approval, the Patent and

Trademark Office received a patent term restoration application for Ray

Threaded Fusion CageTM (U.S. Patent No. 4,961,740) from

United States Surgical Corp., and the Patent and Trademark Office

requested FDA's assistance in determining this patent's eligibility for

patent term restoration. In a letter dated April 11, 1997, FDA advised

the Patent and Trademark Office that this medical device had undergone

a regulatory review period and that the approval of Ray Threaded Fusion

CageTM 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

Ray Threaded Fusion CageTM is 1,861 days. Of this time,

1,357 days occurred during the testing phase of the regulatory review

period, while 504 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 27, 1991. 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, 1991.

However, FDA records indicate that the IDE was determined substantially

complete for clinical studies to have begun on September 27, 1991,

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): June 14,

1995. FDA has verified the applicant's claim that the premarket

approval application (PMA) for Ray Threaded Fusion CageTM

(PMA P950019) was initially submitted June 14, 1995.

3. The date the application was approved: October 29, 1996. FDA has

verified the applicant's claim that PMA P950019 was approved on October

29, 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, this applicant seeks 742 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before December 14, 1998, 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 April 12, 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 (except that

individuals may submit single copies) and identified with the

[[Page 54720]]

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: September 28, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-27284 Filed 10-9-98; 8:45 am]

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