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Biotech titans Genentech Inc. and Chiron Corp. began slugging it out in Sacramento, Calif., federal court Tuesday as both sides told a jury they had invented the technology underlying Genentech’s Herceptin breast cancer drug. In his opening statement, Genentech attorney John Keker of San Francisco-based Keker & Van Nest gave jurors a long, abstruse lecture on the science of monoclonal antibodies. Emeryville, Calif.-based Chiron has sued South San Francisco’s Genentech over commercial rights, saying it holds a key patent to the technology behind Herceptin. In his hourlong opening on Tuesday afternoon, Keker told the jury of eight women and two men that the issue is whether research that Chiron did in the early 1980s pertains to Herceptin. Approved in 1998, Herceptin is one of Genentech’s top-selling products, generating sales of $346 million in 2001. A year after the drug went on the market, Chiron filed suit. The case is one of the largest patent disputes involving questions over early research in the biotechnology field, and hundreds of millions of dollars in potential royalties are at stake. Genentech is going into the trial at a disadvantage. Earlier, it lost a key battle. Genentech had argued that Chiron’s patent pertains solely to monoclonal antibodies produced through a traditional process, not the “humanized” form created by Genentech. But U.S. Magistrate Judge Gregory Hollows ruled in April that the term “monoclonal antibody” includes all antibodies regardless of their origin or how they are produced. Genentech also got into trouble with the court over its contention that antibodies created before Chiron’s patent was issued — dubbed “Drebin/Greene” antibodies — constituted prior art. Hollows found that Genentech had willfully withheld information about its in-house testing of the antibodies. And U.S. District Court Judge William Shubb of the Eastern District of California has already ruled against several of Genentech’s invalidity arguments. In one, the judge said that if Genentech raises a prior art defense based on the Drebin/Greene antibodies at trial, he intends to instruct the jury about Genentech’s withholding of information. Shubb also ordered Genentech to pay Chiron $50,000 in punitive sanctions and attorney fees relating to discovery over the antibodies. During his statements, Keker said Chiron’s patent covers an invention created in the 1980s that is narrower than Genentech’s invention. “Chiron discovered a tree and claims to have discovered the forest,” Keker said. “They want $300 million for doing something they never did.” In 1984, Chiron filed an initial application on the patent, which covers monoclonal antibodies that bind to a human breast cancer antigen known as HER2. The company filed continuance applications to the U.S. Patent and Trademark Office to revise the claims in 1985, 1986 and 1995, and was issued the patent in April 2000. Keker told jurors that the claims in the applications filed in the 1980s specified murine (mouse) monoclonal antibodies and an unknown antigen, while the application after 1995 covered chimeric (part mouse and part human) monoclonal antibodies and humanized monoclonal antibodies. “If they knew about chimeric and humanized monoclonal antibodies they should have been described” in the application, Keker said. But Harold McElhinny, a partner at San Francisco-based Morrison & Foerster who represents Chiron, told jurors in his opening remarks that two Chiron scientists did the work underlying Herceptin. They had the idea “that they could find a way to use the body’s immune system to target individual cancer cells,” McElhinny said. He said they presented a research plan in 1982, subsequently adopted by Chiron, to determine if cancer cells had unique antigens that could be attacked by a manufactured antibody. McElhinny, who began his opening statement late in the afternoon, said in many ways the case is about chronology “and what people knew at what periods of time, [and] what inventions were made.” The trial is scheduled to run into September.

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