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

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

regulatory review period for GenESA 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

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

GenESA (arbutamine hydrochloride). GenESA is

indicated for diagnosing the presence or absence of coronary artery

disease in patients who cannot exercise adequately when used in

conjunction with radionuclide myocardial perfusion imaging or

echocardiography. Subsequent to this approval, the Patent and Trademark

Office received a patent term restoration application for

GenESA (U.S. Patent No. 5,234,404) from Gensia Sicor, Inc.,

and the Patent and Trademark Office requested FDA's assistance in

determining this patent's eligibility for patent term restoration. In a

letter dated December 17, 1998, FDA advised the Patent and Trademark

Office that this human drug product had undergone a regulatory review

period and that the approval of GenESA 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

GenESA is 2,641 days. Of this time, 1,295 days occurred

during the testing phase of the regulatory review period, while 1,346

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

derived from the following dates:

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

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

22, 1990. The applicant claims June 23, 1990, as the date the

investigational new drug application (IND) became effective. However,

FDA records indicate that the IND effective date was June 22, 1990,

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 of the act: January 6, 1994.

The applicant claims December 21, 1993, as the date the new drug

application (NDA) for GenESA (NDA 20-420) was initially

submitted. However, FDA records indicate that NDA 20-420 was submitted

on January 6, 1994.

3. The date the application was approved: September 12, 1997. FDA

has verified the applicant's claim that NDA 20-420 was approved on

September 12, 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 399 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before July 12, 1999, 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 November 8, 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: April 29, 1999.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 99-11822 Filed 5-10-99; 8:45 am]

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