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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E-0452]

Determination of Regulatory Review Period for Purposes of Patent

Extension; VERLUMATM

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 VERLUMATM 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

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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

VERLUMATM (nofetumomab). VERLUMATM is indicated

for the detection of extensive stage disease in patients with biopsy

confirmed, previously untreated small cell lung cancer. Subsequent to

this approval, the Patent and Trademark Office received a patent term

restoration application for VERLUMATM (U.S. Patent No.

4,897,255) from NeoRx 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 July 9, 1997, FDA advised

the Patent and Trademark Office that this human biological product had

undergone a regulatory review period and that the approval of

VERLUMATM represented the first permitted commercial

marketing or use of the product. Shortly thereafter, the Patent and

Trademark Office requested that the FDA determine the product's

regulatory review period.

FDA has determined that the applicable regulatory review period for

VERLUMATM is 3,360 days. Of this time, 925 days occurred

during the testing phase of the regulatory review period, 2,435 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: June 11, 1987. The applicant claims

September 4, 1987, as the date the investigational new drug application

(IND) became effective. However, FDA records indicate that the IND

effective date was June 11, 1987, which was 30 days after FDA receipt

of the IND.

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

the human biological product under section 351 of the Public Health

Service Act: December 21, 1989. FDA has verified the applicant's claim

that the Product License Application (PLA) for VERLUMATM

(PLA 90-0150) was initially submitted on December 21, 1989.

3. The date the application was approved: August 20, 1996. FDA has

verified the applicant's claim that PLA 90-0150 was approved on August

20, 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 1,298 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before September 8, 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 January 6, 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: June 29, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-18408 Filed 7-9-98; 8:45 am]

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