Taxane suit decided

Five years of rancorous litigation over whose name belongs on the patent for analogs of the anticancer taxane class of compounds ended last week with a federal appellate ruling against Florida State University (FSU) in favor of generic drug giant American BioScience (ABI).The June 23rd ruling removed FSU researchers including Robert Holton from the list of inventors of three taxane analogs and reinstated Patrick Soon-Shiong, president and chief executive officer of ABI, and other researchers from his company.Though the ruling was a defeat for FSU, which had prevailed at the lower court level, it does not endanger the stream of revenues to the school from Holton's work as inventor of the semisynthetic form of Taxol. The breast and ovarian cancer treatment that has brought the school more than $300 million in royalties since the mid-1990s was not at issue in this case. However, compounds that could represent the next generation of improved taxane cancer treatments were at stake. With Taxol royalties in decline, FSU's hope of maintaining its research revenue stream are pinned on new taxane analogs, which are less toxic than Taxol and less likely to trigger resistance, FSU Director of Technology Transfer John Fraser told The Scientist.ABI has similar hopes for the compounds that were the subject of the case decided by the US Court of Appeals for the Federal Circuit. Based on taxotere rather than Taxol, the compounds show promise for improving Taxol's performance in making cancer cells more susceptible to radiation therapy, said ABI's Patrick Soon-Shiong.While ABI won on appeal, it lost years of development time on the compounds, said Soon-Siong. He and other ABI researchers were removed from the list of inventors by a trial court that found inequitable conduct on ABI's part in landing the patent. That inequitable conduct finding was overturned by the appellate court, leaving ABI free to move ahead to develop the compounds.Coupled with a nanoparticle technology that harnesses biologically active protein albumin molecules as delivery vehicles, the taxotere analogs show promise of enhanced radiosensitization capability, Soon-Shiong said. "Imagine unleashing the power of the intrinsic biological activity of a transport molecule that you have been able to maintain and yet convert into a nanoparticle," he said, explaining the development strategy that was interrupted in 1998 by the onset of the litigation concluded last week.A potboiler of a case, the lawsuit began with charges from FSU that Chunlin Tao, a postdoc who came from China to work in Holton's lab, had misappropriated trade secrets learned at FSU and used them to apply for a patent in his name after ABI hired him. That allegation was not before the federal circuit appeals panel, having been settled earlier in a consent judgment that called for ABI to pay FSU $300,000. ABI says it settled because it would have cost more to defend against the charges and because the litigation would have stressed Tao, a young scientist, even more than what the company saw as FSU's unfair hounding had already done. "They consented to a judgment for money damages based on FSU's claim of theft of trade secrets," said Sidney L. Matthews, a Tallahassee lawyer who represented FSU. "The court recognized that. At the same time the court felt constrained to uphold the patent."According to Matthews, the case was not an effort to get control of the compounds Tao developed at ABI. "We're not interested in those compounds. We're interested in the ones that work," the FSU lawyer said. The point of the litigation in the school's view was to protect the principle that trade secrets are not free for the taking, even in public research universities, Matthews added.Privately held ABI is majority owner of American Pharmaceutical Partners, a Schaumburg, Ill.–based drug company with a market capitalization over $1.64 billion. A majority of ABI is owned by a trust of which Soon-Shiong and his wife are beneficiaries.

Taxane suit decided

Court rules against Florida State University in bitter battle with American BioScience

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