Determination of Regulatory Review Period for Purposes of Patent Extension; PRO OSTEONSUPTM Implant 500 Coralline Hydroxyapatite Bone Void Filler

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 92E-0506]

Determination of Regulatory Review Period for Purposes of Patent

Extension; PRO OSTEONTM Implant 500 Coralline Hydroxyapatite Bone

Void Filler

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 PRO OSTEONTM Implant 500 Coralline

Hydroxyapatite Bone Void Filler 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, rm.

1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John S. Ensign, Office of Health

Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301-443-1382.

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 PRO

OSTEONTM Implant 500 Coralline Hydroxyapatite Bone Void Filler.

The PRO OSTEONTM Implant 500 Coralline Hydroxyapatite Bone Void

Filler is indicated for the repair of acute metaphyseal fracture

defects and is to be used in conjunction with rigid internal fixation

as dictated by the clinical use requirements in skeletally mature

individuals when there is no autogenous bone donor site available.

Subsequent to this approval, the Patent and Trademark Office received a

patent term restoration application for the PRO OSTEONTM Implant

500 Coralline Hydroxyapatite Bone Void Filler (U.S. Patent No.

3,929,971) from Research Corp. Technologies, and the Patent and

Trademark Office requested FDA's assistance in determining this

patent's eligibility for patent term restoration. FDA, in a letter

dated December 31, 1992, advised the Patent and Trademark Office that

this medical device had undergone a regulatory review period and that

the approval of the PRO OSTEONTM Implant 500 Coralline

Hydroxyapatite Bone Void Filler represented the first commercial

marketing 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

PRO OSTEONTM Implant 500 Coralline Hydroxyapatite Bone Void Filler

is 3,774 days. Of this time, 2,049 days occurred during the testing

phase of the regulatory review period, while 1,725 days occurred during

the approval phase. These periods of time were derived from the

following dates:

1. The date a clinical investigation on humans involving this

device was begun: July 2, 1982. FDA has verified the applicant's claim

that the investigational device exemption required under section 520(g)

of the Federal Food, Drug, and Cosmetic Act became effective on July 2,

1982.

2. The date an application was initially submitted with respect to

the device under section 515 of the Federal Food, Drug, and Cosmetic

Act: February 9, 1988. The applicant claims February 8, 1986, as the

date the premarket approval application (PMA) for the PRO OSTEONTM

Implant 500 Coralline Hydroxyapatite Bone Void Filler (PMA P860005) was

filed. However, FDA records indicate that PMA P860005 was initially

submitted on February 9, 1988.

3. The date the application was approved: October 29, 1992. FDA has

verified the applicant's claim that PMA P860005 was approved on October

29, 1992.

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 730 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before May 10, 1994, 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 September 7, 1994, 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 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: December 28, 1993.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 94-5672 Filed 3-10-94; 8:45 am]

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