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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0293]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Skelid

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

regulatory review period for Skelid 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

Skelid (tiludronate disodium). Skelid is indicated

for treatment of Paget's disease of bone (osteitis deformans).

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

patent term restoration application for Skelid (U.S. Patent

No. 4,876,248) from Sanofi Pharmaceuticals, 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

November 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 Skelid 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

Skelid is 2,013 days. Of this time, 1,639 days occurred

during the testing phase of the regulatory review period, 374 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:

September 4, 1991. FDA has verified the applicant's claim that the date

the investigational new drug application became effective was on

September 4, 1991.

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

the human drug product under section 505 of the act: February 28, 1996.

FDA has verified the applicant's claim that the new drug application

(NDA) for Skelid (NDA 20-707) was initially submitted on

February 28, 1996.

3. The date the application was approved: March 7, 1997. FDA has

verified the applicant's claim that NDA 20-707 was approved on March 7,

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 1,192 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before December 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 April 7, 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: September 28, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-27078 Filed 10-8-98; 8:45 am]

BILLING CODE 4160-01-F