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Judge: Patent in Imclone Case Is Israelis

September 19, 2006

NEW YORK (AP) _ In a blow to ImClone Systems Inc. and a triumph for a prominent Israeli research institution, a judge ruled Monday that three scientists from Israel are the true inventors of a process used in the delivery of the blockbuster cancer drug, Erbitux.

U.S. District Judge Naomi Reice Buchwald directed the U.S. Patent and Trademark Office to replace seven names now on the controversial patent with those of Professor 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 Rehobot, Israel, 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 ImClone will lose exclusive rights to the process used to deliver the drug.

It was unclear when the patent credit names would be formally changed. Appeals to 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.

Other lawsuits are pending against one or both of the companies for patents obtained in England, Germany, France and Austria.

Nicholas Groombridge, who argued the case for Yeda, praised the decision and said it will be welcomed by the scientists.

``People that devote their lives to science, what they care about more than anything else is recognition. They will be really, really happy to feel they have finally gotten public recognition,″ he said.

Groombridge said Yeda will 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.″

Instead, he said, ``it will increase access to the benefits of this invention.″

Messages left with lawyers for the defendants were not immediately returned.

The invention 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 cancer in a manner that has more success against some cancers than some other methods.

The discovery in the late 1980s was made by the three Weizmann researchers using an antibody provided by Joseph Schlessinger, a one-time Weizmann researcher who was working at 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 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 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.″

During the summer trial, an Aventis lawyer noted that one trial witness had remarked that hundreds of millions of dollars were at stake for Yeda and Erbitux, which is distributed in the U.S. by Bristol-Myers Squibb Co.

Also at stake were the reputations of some of the world’s most renowned cancer researchers.

The judge noted that Scientist magazine has said Schlessinger’s publications are 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.″

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