ICN announced that the European Union has granted ICN a new patent covering manufacture of the drug ribavirin for medical treatment of three families of viruses, including the virus responsible for the worldwide hepatitis C epidemic that infects 140 million people.

In Europe, the new patent -- assigned patent number EP - 0643970 by the European Patent Office -- is issued to ICN in Great Britain, Germany, France, Austria, Switzerland, Sweden, Netherlands and Italy.

In the United States, Schering-Plough was granted a use patent in January 2001 for combination use of ribavirin and forms of alpha interferon to treat hepatitis C. In addition to the Schering-Plough use patent in the United States, ICN was also recently issued patents in Australia, Canada, New Zealand, and South Korea, covering the use of ribavirin as an immunomodulator in the treatment of hepatitis C virus. Several other patent applications are still pending in Europe, Asia, and elsewhere related to this, and other aspects of ribavirin.

ICN receives significant royalties from Schering-Plough for worldwide sales of ribavirin in combination therapy for treatment of hepatitis C under the tradename Rebetol. In March 2001, Pegintron (pegylated intereferon) and Rebetol combination therapy was granted centralized marketing authorization in the European Union for the treatment of both relapsed and previously untreated adult patients with histologically proven chronic hepatitis C. According to the latest statistics from the World Health Organization, up to eight million Europeans are infected with the potentially-fatal hepatitis C virus.

Schering-Plough, which has licensed the oral form of ribavirin from ICN, holds an approved NDA for combination therapy which currently provides regulatory protection that prohibits competitors from offering a similar product. The newly issued patent provides additional legal protection against competitors that might market ribavirin by itself, or in combination with any other compound for the treatment of hepatitis C in Europe.

ICN and Schering-Plough patents and patents pending relating to ribavirin include the following:

1) Three U.S. patents (hepatitis C method of use) through January, 2016

2) Schering-Plough U.S. use patent granted 2001

3) Two formulation patents on oral ribavirin through 2017

4) Ribavirin data exclusivity in Europe through 2009

5) Japan, 6 years data exclusivity upon approval

ICN has received correspondence from another pharmaceutical company that it has filed an aNDA for ribavirin. ICN is evaluating the correspondence with its patent counsel and will vigorously defend its position.

Ribavirin is a product of ICN's nucleic acid research and discovery program. Ribavirin is also marketed in the United States and the European Union for aerosol use in the treatment of hospitalized infants and young children with severe lower respiratory tract infection caused by the respiratory syncytial virus (RSV), and is marketed in a total of 44 countries in a variety of forms around the world for 10 different viral indications sold by ICN.