Determination of Regulatory Review Period for Purposes of Patent Extension; BeneFIXSUPTM/SUP

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0168]

Determination of Regulatory Review Period for Purposes of Patent

Extension; BeneFIXTM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the

regulatory review period for BeneFIXTM 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 human biological product.

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 human biological products, the

testing phase begins when the exemption to permit the clinical

investigations of the biological becomes effective and runs until the

approval phase begins. The approval phase starts with the initial

submission of an application to market the human biological product and

continues until FDA grants permission to market the biological product.

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 (for example, 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 human biological product will include all of the testing

phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing the human biological product

BeneFIXTM (coagulation factor IX (Recombinant)).

BeneFIXTM is indicated for the control and prevention of

hemorrhagic episodes in patients with hemophilia B, including the peri-

operative management of hemophilia B patients undergoing surgery.

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

patent term restoration application for BeneFIXTM (U.S.

Patent No. 5,171,569) from British Technology Group Ltd., 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 21, 1997, FDA advised the Patent and Trademark Office that

this human biological product had undergone a regulatory review period

and that the approval of BeneFIXTM 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

[[Page 41580]]

BeneFIXTM is 749 days. Of this time, 583 days occurred

during the testing phase of the regulatory review period, while 166

days occurred during the approval phase. These periods of time were

derived from the following dates:

1. The date an exemption under section 351 of the Public Health

Service Act became effective: January 26, 1995. FDA has verified the

applicant's claim that the date the investigational new drug

application became effective was on January 26, 1995.

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

the human biological product under section 351 of the Public Health

Service Act: August 30, 1996. The applicant claims August 29, 1996, as

the date the Product License Application (PLA) for BeneFIXTM

(PLA 96-1048) was initially submitted. However, FDA records indicate

that PLA 96-1048 was submitted on August 30, 1996.

3. The date the application was approved: February 11, 1997. FDA

has verified the applicant's claim that PLA 96-1048 was approved on

February 11, 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 423 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before October 5, 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 February 1, 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 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: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-20742 Filed 8-3-98; 8:45 am]

BILLING CODE 4160-01-F