Determination of Regulatory Review Period for Purposes of Patent Extension; GEMZARRegister

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E-0314]

Determination of Regulatory Review Period for Purposes of Patent

Extension; GEMZAR

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

regulatory review period for GEMZAR 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 drug 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 drug products, the

testing phase begins when the exemption to permit the clinical

[[Page 41264]]

investigations of the drug becomes effective and runs until the

approval phase begins. The approval phase starts with the initial

submission of an application to market the human drug product and

continues until FDA grants permission to market the drug 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 drug 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 drug product

GEMZAR (gemcitabine hydrochloride). GEMZAR is

indicated for use as a firstline treatment for patients with locally

advanced (nonresectable stage II or stage III) or metastatic (stage IV)

adenocarcinoma of the pancreas in patients previously treated with 5-

FU. Subsequent to this approval, the Patent and Trademark Office

received a patent term restoration application for GEMZAR

(U.S. Patent No. 4,808,614) from Eli Lilly & Co., and the Patent and

Trademark Office requested FDA's assistance in determining this

patent's eligibility for patent term restoration. In a letter dated

March 7, 1997, FDA advised the Patent and Trademark Office that this

human drug product had undergone a regulatory review period and that

the approval of GEMZAR 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

GEMZAR is 3,293 days. Of this time, 2,824 days occurred

during the testing phase of the regulatory review period, 469 days

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

from the following dates:

1. The date an exemption under section 505(i) of the Federal Food,

Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:

May 12, 1987. The applicant claims June 18, 1987, as the date the

investigational new drug application (IND) for GEMZAR became

effective. However, FDA records indicate that the IND effective date

was May 12, 1987, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect

to the human drug product under section 505(b) of the act: February 2,

1995. FDA has verified the applicant's claim that the new drug

application (NDA) for GEMZAR (NDA 20-509) was initially

submitted on February 2, 1995.

3. The date the application was approved: May 15, 1996. FDA has

verified the applicant's claim that NDA 20-509 was approved on May 15,

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 1,537 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before October 2, 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. 98-20593 Filed 7-31-98; 8:45 am]

BILLING CODE 4160-01-F