Chiron and Ortho prevail in HCV litigation; U.K. court grants permanent injunction against Murex and Organon.

EMERYVILLE, Calif.--(BUSINESS WIRE)--Nov. 29, 1994--Chiron Corp. (NASDAQ:CHIR) announced Tuesday that the High Court of Justice for England and Wales has granted a permanent injunction against the manufacture and sale of hepatitis C virus (HCV) immunoassays by Murex Diagnostics, Ltd., a unit of International Murex, and Organon Teknika Ltd., a unit of the Dutch Akzo Nobel Group.

The court, after hearing arguments by Chiron and the defendants, ruled that an injunction should be granted based on infringement by Murex and Organon's HCV immunoassays of Chiron's British patent No. GB 2,212,511 (the "511" patent). The amount of damages to be assessed will be determined in a separate hearing.

The suit was brought against Murex and Organon by Chiron and Ortho Diagnostic Systems Inc. and Ortho Diagnostic Systems Ltd., Johnson and Johnson companies.

At the conclusion of the hearing to decide on the injunction, Murex and Organon withdrew their claim that an injunction would be contrary to the public interest. However, the defendants requested that the court exclude from the injunction Murex' new serotyping assay used in diagnostic laboratories, arguing a strong public interest in the current availability of serotyping assays.

In addition, Murex and Organon asked that the injunction not apply to any HCV research and development. The court denied both requests. However, the court accepted the voluntary offer by Chiron and Ortho that the injunction should not prevent Murex from manufacturing and selling its HCV serotyping assay pending an appeal, and pointed out that the injunction does not prevent non-commercial research on HCV. The appeal is expected to be heard in October 1995.

"We are pleased with the decision of the court, and confident that Ortho-Chiron and its licensees will be able to meet the needs of the entire UK market," said William G. Gerber, M.D., president of Chiron Diagnostics. "We believe that the public interest is best served by the high-quality HCV tests developed by Ortho-Chiron and their licensees. The court's decision is consistent with recent rulings on the continent removing unlicensed HCV tests from the European market. Together with Ortho, we will continue to defend our patent against infringers." Chiron and Ortho are pursuing actions against further infringement by Organon and Murex in several jurisdictions. In addition to Ortho, Abbott Laboratories and Pasteur Sanofi Diagnostics are licensed to sell HCV immunoassays in Europe.

To date, Chiron has been granted 27 HCV patents in 20 countries, including the U.S. and all Western European countries. Most recently, Chiron was granted the company's first in an expected series of U.S. patents for its HCV inventions. On July 25, the District Court in The Hague, Netherlands, granted a cross-border European injunction against the manufacture, sale and distribution of HCV immunoassays infringing Chiron's European HCV patent (No. 0,318,216) by Organon, and United Biomedical Inc. (UBI), the United States company that manufactures HCV immunoassays for Organon. On November 15, 1993, Chiron's first Japanese patent application for HCV (No. 1-500565) published for opposition, or Kokoku publication, following an initial decision by the Japanese Patent Office to grant Chiron's claims. Recently, Chiron filed a lawsuit in Tokyo requesting a preliminary injunction against sale of HCV assays in Japan.

Claims of the British "511" patent cover many aspects of Chiron's HCV technology, including: antigenic HCV polypeptides (including structural and non-structural), regardless of method of production (e.g. recombinant, synthetic, etc.); HCV antibodies; the use of such polypeptides and antibodies in immunoassays; HCV polynucleotides; and the use of such polynucleotides in recombinant protein expression, DNA probe tests and PCR (polymerase chain reaction) tests.

HCV is an infection of the liver which is transmitted via transfusion, intravenous drug use and possibly sexual activity. In 1987, Chiron scientists identified, cloned and sequenced the virus, the cause of most non-A, non-B hepatitis cases. Subsequently, Chiron and Ortho developed an assay to detect the presence of HCV antibodies. Today, the Chiron-Ortho joint diagnostics business is the world's leading supplier of microplate tests for detecting hepatitis viruses and retroviruses.

Chiron Corp. is a biotechnology company headquartered in Emeryville, Calif., near San Francisco. Chiron is building a healthcare busienss that addresses needs in several markets: diagnostics, including immunodiagnostics and bDNA probe assays; vaccines, emphasizing adult and pediatric infectious diseases; therapeutics, with an emphasis on oncology, endocrinology and serious infectious and other diseases requiring critical care; and ophthalmic products for the surgical correction of vision.

CONTACT: Chiron Corporation

              Larry Kurtz, 510/601-2476
              Kimberly Kraemer, 510/601-2412