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Feds review complaints that Chiron hinders HCV research
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By Paul Elias / AP Biotechnology Writer
Saturday, February 28, 2004
http://www.detnews.com/2004/health/0402/29/health-76978.htm
SAN FRANCISCO -- Industry scientists have complained for years that Chiron Corp. has hindered the fight against hepatitis by creating a virtual commercial monopoly over drug research.
Now, federal health officials are reviewing the 14-year-old government agreement that gave Chiron so much control over research that seeks to help the 170 million people afflicted with the disease.
Chiron holds 100 patents in 20 countries related to hepatitis C. Competitors complain they've abandoned plans to enter the field because Chiron demands too much money to access its technology. Chiron has successfully sued many companies for infringing its patents related to the virus.
Those patents credit Chiron scientists with discovering the hepatitis C virus -- despite the fact that a scientist from the Centers for Disease Control and Prevention contributed much to the original research.
But the CDC signed away to Chiron most of the commercial control of the virus for a little more than $2.2 million in 1990.
"There have been a number of individuals in the scientific community that are involved in the prevention, treatment and research of hepatitis C that have said the agreement is having an impact on the scientists' ability to address hepatitis C," said CDC spokesman Tom Skinner. "We are looking into whether or not the agreement we have in place with Chiron is having an impact and, if so, what kind of impact."
Skinner couldn't provide any names of complaining scientists, details of what was being reviewed or what projects may be affected. He said he was unsure if the CDC's inquiry would ever expand beyond informal discussions.
Skinner's not even sure what recourse the CDC may have 14 years after signing the contact and said other CDC officials weren't available to comment.
What's more, many companies involved in hepatitis C research are reluctant to publicly discuss Chiron's tactics. Most have been sued at one time or another by Chiron, and several have settled their lawsuits in recent months and say they just want to get on with the research.
Still, the CDC concern highlight the ongoing tension between the U.S. patent system and free scientific inquiry.
The CDC inquiry also illustrates how sophisticated the government and universities have become in the last decade with intellectual property originating in their labs.
The CDC, for instance, claims ownership of the SARS virus and its entire genetic content after its researchers helped map the bug's genome. Rather than try to profit from it, the CDC wants to prevent others from monopolizing the field the way Chiron does with hepatitis C.
"The intellectual property was pretty new and at that time everybody was learning how to deal with it," said former CDC official Walter Dowdle, one of three government officials to sign the Chiron deal. "This was very early in the intellectual property business between companies and government."
Though academic scientists say they've encountered few problems working with the company, they still can't turn their discoveries into drugs without industry help.
Chiron said the CDC hasn't notified it of any review and defended its handling of its patents. Spokesman John Gallagher said the Emeryville-based company has deals with 13 competitors that allow them to pursue hepatitis C drugs with Chiron's patented technology.
Gallagher said Chiron makes its technology freely available to nonprofit research scientists, many of whom credit the company with funding hepatitis C science meetings and supporting academic endeavors.
"I would challenge anyone to show us anyone who has done as much as Chiron has," Gallagher said.
Hepatitis C is a blood-borne virus, often contacted by sharing needles, and can lead to chronic liver disease and liver cancer. Disease rates have fallen in the United States but are on the rise in developing nations.
Chiron's scientists in 1987 developed a technique to clone multiple versions of the elusive hepatitis C virus, which allows researchers to easily generate billions of viruses to research. Chiron received a patent for the discovery three years later.
The CDC filed a competing patent application, listing government scientist Dan Bradley as a co-discoverer. But in 1990, the government and Bradley withdrew their claims as co-inventors and renounced all rights after Chiron paid the CDC $1.9 million and Bradley $337,500.
In 1994, Bradley unsuccessfully sued Chiron in an attempt to undo the deal. He dropped his quest after losing a federal appeal four years later. Bradley, who has left the CDC, couldn't be reached through his lawyer.
"I have always thought Dan Bradley got a raw deal by being excluded from the patent," Scripps Research Institute researcher Dr. Frank Chisari said in an e-mail interview. "That dispute was settled a long time ago after a great deal of pressure by Chiron lawyers."
While Chisari said he had no problems personally with Chiron, he added: "I believed then and I believe now that Chiron scientists wouldn't have cloned the viral genome when they did if Dan Bradley and his colleagues at the CDC hadn't provided them with meticulously pedigreed material containing the genome."
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