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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0796]

Determination of Regulatory Review Period for Purposes of Patent

Extension; LumenHance

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 LumenHance 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. 100670) 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

LumenHance (manganese chloride USP). LumenHance is

indicated for use as a magnetic resonance imaging (MRI) contrast media,

to enhance the delineation of the upper gastrointestinal tract to

distinguish it from organs and tissues that are adjacent to the upper

regions of the gastrointestinal tract. Subsequent to this approval, the

Patent and Trademark Office received a patent term restoration

application for LumenHance (U.S. Patent No. 5,368,840) from

Bracco Diagnostics 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 14, 1998, FDA advised the

Patent and Trademark Office that this human drug product had undergone

a regulatory review period and that the approval of

LumenHance 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

LumenHance is 1,796 days. Of this time, 1,067 days occurred

during the testing phase of the regulatory review period, while 729

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: The

applicant claims January 18, 1993, as the date the investigational new

drug application (IND) became effective. However, FDA records indicate

that the IND effective date was January 20, 1993, 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: December 22, 1995.

The applicant claims December 20, 1995, as the date the new drug

application (NDA) for LumenHance (NDA 20-686) was initially

submitted. However, FDA records indicate that NDA 20-686 was submitted

on December 22, 1995.

3. The date the application was approved: December 19, 1997. FDA

has verified the applicant's claim that NDA 20-686 was approved on

December 19, 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 20 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before May 3, 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 August 30, 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

[[Page 10304]]

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: February 16, 1999.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 99-5130 Filed 3-2-99; 8:45 am]

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