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Viral Combat 

Chiron Corp. and the nasty fight over the billion-dollar rights to the hepatitis C test

Wednesday, Mar 11 1998
One day in May 1988, Dr. Daniel Bradley, a scientist with the federal Centers for Disease Control, received a phone call from Michael Houghton, a researcher at the Chiron Corp., an Emeryville-based biotechnical firm. Bradley, Houghton, and their associates had been collaborating for six years on research into a mysterious and often fatal type of hepatitis that had defied identification and treatment. But the collaboration had deteriorated over time. Chiron and the government had sparred over the exact terms of their joint research agreement; Bradley and Houghton had spoken less and less.

Houghton's call encouraged Bradley to attend a meeting at Chiron's Bay Area headquarters, without specifying why. Rather than explain, Houghton told Bradley he would learn some "interesting information" at the meeting. Bradley, then working in Atlanta, flew west, and when he arrived at Chiron's growing maze of East Bay offices and laboratories, was told he would have to sign a two-page confidentiality agreement before he could attend the meeting.

He signed, and did, indeed, learn interesting news. At the meeting, Chiron's scientists announced that they had found the key that unlocked a great part of the mysterious hepatitis virus that Bradley had been studying for a decade. In short, they had cloned proteins from the virus now known as hepatitis C and developed a prototype for a blood-screening test for the disease.

The discovery of a way to determine who was, and was not, infected with the hepatitis C virus represented one of the most significant scientific advances in recent history. A major public health threat, hepatitis C quietly tortures 4 million people in the United States, and as many as 100 million people around the world. It is expected to soon pass AIDS as a major cause of death in the United States. A test for infection by the virus, known in scientific parlance as HCV, also constitutes one of the most valuable pharmaceutical assets in existence, with an estimated worth of $1 billion.

That evening, Bradley joined Houghton, Chiron founders William Rutter and Edward Penhoet, and other company scientists at a celebratory cocktail party at a San Francisco hotel. There, Bradley found out that Chiron had filed a patent application for its new discovery. He approached Rutter and asked if his name was on the patent. Rutter politely told Bradley no. Although he thanked the scientist for his work, Rutter said Bradley's contribution to the research collaboration on hepatitis C did not warrant his being named as an inventor of the methods and products specified in Chiron's patent.

Furious, Bradley left and soon began what has become an international legal battle of remarkable proportions. During the past decade, biotechnology firms, pharmaceutical companies, the federal government, and the brightest minds in science have disputed in courts in at least six different countries and have spent tens of millions of dollars seeking control of a method of testing for the hepatitis C virus. And as Chiron and other research enterprises chase the vast amounts of money and acclaim connected to the holy grail of HCV research -- a hepatitis C vaccine -- the warfare is likely, if anything, to intensify.

About 170,000 new cases of hepatitis C are diagnosed in this country every year. Another 350,000 a year show up in Japan, an inexplicable hot spot for the virus. A recent study conducted by the University of California, San Francisco and the Haight Ashbury Free Medical Clinic shows that as many as 50 percent of injection drug users below the age of 30 in San Francisco are infected with hepatitis C, a nasty sickness for which there is no cure.

The hepatitis C virus is passed primarily through blood transfusions and dirty needles. A smaller number of infections is transmitted through sexual contact. An overwhelming majority of people infected with HCV develop a chronic liver disease. About 20 percent of them become afflicted with cirrhosis and liver cancer. And as many as 10,000 victims die every year. The rest live in hell.

HCV brings its victims nausea and diarrhea, and leaves them weak and jaundiced. It fills livers with scar tissue. It feels like a bad flu that just won't go away.

The poor tend to be infected with HCV at higher rates than the wealthy, which means that minority populations are disproportionately affected by the disease. Naomi Judd and Mickey Mantle made hepatitis C famous. Hemophiliacs are at great risk; more than 50 percent of the prison population is suspected to be infected.

Some 13 million units of blood are given by transfusion every year in the United States alone. Before the HCV test became available in 1989, there was no way to screen blood for the virus. HCV can take as long as two decades after initial infection to attack its victims, so a great many people infected with the hepatitis C virus don't even know it yet.

Now, though, there is a screening test, and a way to diagnose definitively whether a patient does or doesn't have hepatitis C. Even though Dr. Daniel Bradley and his government-funded research contributed to the development of that test, Chiron, and Chiron alone, owns the billion-dollar right to license it.

Until -- or unless -- a court rules otherwise.

In 1971, armed with a doctoral degree in biochemistry, Daniel Bradley left the University of Arizona in Tucson and went to work for the National Institutes of Health/Centers for Disease Control laboratory in Phoenix. There, Bradley spent the better part of his career searching blood samples for clues that would unlock the mystery of what would eventually be called hepatitis C.

By the mid-1970s, it was known that there was another virus attacking human livers besides the two forms of hepatitis that had already been identified. Researchers all over the globe were searching for the new pathogen. Bradley was among them.

In 1977, he acquired bottles of a blood-clotting agent that had been transfused into three patients and, it was thought, had infected them with the mystery illness. (Clotting agents are widely used to treat hemophiliacs.) Somewhere in these agents, he thought, was the key to the new disease, but the virus causing the disease -- if it were a virus -- was either too fragile or too weakly concentrated to be found under a microscope.

About The Author

Lisa Davis


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