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In a blow to ImClone Systems Inc. and a triumph for a prominent Israeli research institution, a federal judge ruled Monday that three Israeli scientists are the true inventors of a process used in the delivery of the top-selling cancer drug, Erbitux.
US District Judge Naomi Reice Buchwald directed the US Patent and Trademark Office to replace seven names now on the controversial patent with those of Prof. Michael Sela, Dr. Esther Aboud-Pirak and Dr. Esther Hurwitz. The three scientists made the pioneering cancer discovery at the Weizmann Institute of Science in Rehovot in the late 1980s.
In a 140-page opinion, Buchwald indicated it was not a close call because the events described by the researchers and their experts were "strongly corroborated" by documents, while the version presented by the defendants was not. She also found that the plaintiffs' witnesses were, "as a whole, far more credible than the defendant's witnesses."
Lawyers had predicted the case could significantly affect the future of Erbitux, a colon-cancer treatment drug made by ImClone, the company whose founder, Sam Waksal, is serving a prison sentence for his role in the stock scandal that also ensnared Martha Stewart. The ruling means the company will lose exclusive rights to the process used to deliver the drug. Its patent had been due to expire in 2017.
Erbitux is ImClone's only commercially available drug. As of the date of the trial, the company had received about $900 million in revenue under its distribution agreement in the US with Bristol-Myers Squibb Co.
It was unclear when the patent credit names would be formally changed. Appeals of the judge's ruling could be filed.
The ruling was the first judgment in lawsuits brought in five countries by Yeda Research & Development Co., Weizmann's licensing arm, against ImClone, which licenses the patent, or Aventis Pharmaceuticals Inc., which owns the patent.
Nicholas Groombridge, who argued the case for Yeda, praised the decision and said it would be welcomed by the scientists.
Groombridge said Yeda would seek to license the patent to ImClone and "as many people as possible, anyone willing to agree to commercially agreeable terms." He said "no one will be barred from receiving any treatment as a consequence of this decision."
Messages left with lawyers for the defendants were not immediately returned.
The discovery that resulted in the patent was a finding that a particular antibody such as that in Erbitux can be combined with chemotherapy to fight the growth of some cancers more successfully than some other methods.
The discovery was made by the Weizmann researchers using an antibody provided by Joseph Schlessinger, a one-time Weizmann researcher who was working for a predecessor of Aventis. He is now chairman of pharmacology at the Yale School of Medicine.
Schlessinger, 61, whose name has been on the patent, testified on behalf of the defendants during a 10-day hearing before Buchwald during the summer that he and his colleagues "generated the only unique material here."
The judge said Monday that the Weizmann scientists were not included as inventors on the patent even though they had conducted all of the experiments relating to mixing the antibody and chemotherapy drugs.
"Schlessinger in no way directed the research of the Weizmann scientists and had absolutely no interaction with them during the course of their experimentation," she said.
The judge said that the predecessor company to Aventis and later ImClone copied the text and figures from a paper drafted by the Weizmann scientists into their patent applications.
Buchwald said the Weizmann researchers did not learn that Aventis and ImClone were pursuing patents until 12 years after the first patent application and only 14 months before the patent was issued. The lawsuit was brought in 2003.
The judge said Aventis and ImClone "engaged in a series of actions designed to keep Yeda and the Weizmann scientists in the dark." She said ImClone could not claim Yeda waited too long to file lawsuits because of the "extraordinary lengths defendants undertook to prevent the named inventors from discovering their actions."
ImClone said in a press release it would appeal because it still believed the original patent's authors were correctly named. The company said it did not believe the ruling would adversely impact its operations, including sales of Erbitux.
After 11 years of clinical trials, Erbitux was approved by the US Food and Drug Administration in February 2004 for the treatment of colorectal cancer and in March for treatment of head and neck cancers.
On September 19, 2001, Bristol Myers Squibb agreed to pay ImClone up to $2 billion to jointly commercialize Erbitux.
The judge noted that the $900m. ImClone had already received represented more than four and a half times its $190m. in research and development expenses.
Also at stake, besides revenue to ImClone, were the reputations of some of the world's most renowned cancer researchers.
The judge noted that Scientist magazine had said Schlessinger's publications were among the most-cited papers in the world. He testified he had been nominated for a Nobel Prize.
Sela, 82, is a former president of Weizmann. Along with others, he invented Copaxone, the most widely used drug for treating multiple sclerosis.
Sela testified that he and other researchers cared most about their work and left the pursuit of patents to others.
"I don't mind if I don't take a patent, unless it's stolen from me. Then I have to react," he said. "At the beginning, when I first saw it, I was in a state of shock. I mean, money is not important, but my name and my science, my honor demanded I should be replaced."