[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5672]


[[Page Unknown]]

[Federal Register: March 11, 1994]


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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]
BILLING CODE 4160-01-F