ImClone, cancer drug embroiled in bitter patent dispute

A judge in Manhattan federal court is deciding who is the rightful owner of a patent used for ImClone Systems Inc.'s blockbuster cancer drug Erbitux. A team of three esteemed scientists from Israel who pioneered a cancer treatment technique claim a former colleague stole their idea and was credited on a patent now owned by Aventis Pharmaceuticals Inc. and licensed to ImClone. At stake is the future of ImClone, the company whose founder, Sam Waksal, is serving a prison sentence for his role in the stock scandal that also ensnared Stewart. Erbitux, initially approved to treat colectoral cancer and later expanded to treat head and neck cancer, has contributed heavily to ImClone's success, although the company is facing serious competition from a drug by rival Amgen Inc. that is expected to hit the market in the coming months. Still, ImClone posted robust earnings Thursday thanks to strong sales of Erbitux, which provided about half of the company's total revenue. But any future earnings could be clouded by the patent lawsuit. In the 2003 suit, Yeda Research and Development Co. of Israel sued ImClone -- which has an exclusive license for the formula used in Erbitux to inhibit tumor cells -- and Aventis, claiming three of its researchers should be named as the inventors. The current patent names Dr. Joseph Schlessinger, Chairman of Pharmacology at the Yale School of Medicine, as the inventor along with six others, three of whom even the defense has agreed do not belong on the patent. One of the Israeli researchers, Michael Sela, testified that he considers Schlessinger ``a superb scientist, a very good lecturer,'' and had thought of him as a friend and colleague before ``the bad moment.'' ``I have a problem with his ethics,'' said Sela, a professor for 56 years at the Weizmann Institute of Science in Rehovot, Israel. Schlessinger was a longtime researcher at the institute. In recent weeks, U.S. District Judge Naomi Buchwald has heard testimony from Sela, Schlessinger and other top cancer researchers. She has not yet ruled, and it is not clear when she might do so. But she was critical of many of the arguments presented by lawyers for ImClone and Aventis during closing statements Wednesday. The consequences could be huge for ImClone if Buchwald rules in favor of the Israeli researchers. At one point Wednesday, plaintiffs' lawyer Nicholas Groombridge said ImClone stands to lose its exclusivity with the technique covered by the license if Yeda's scientists are credited, freeing Yeda to license the patent to other drug companies. If Schlessinger is taken off the patent -- something the judge indicated was a possibility -- ImClone would not have a license anymore for the drug, he said. ``I presume there would be a negotiation and a deal would be reached,'' he said. ``It is not the intent of Yeda to keep anybody off the market.'' A lawyer for Aventis later noted that one trial witness had remarked that hundreds of millions of dollars were at stake for Yeda and ImClone. Erbitux is distributed in the U.S. by Bristol-Myers Squibb Co., and had U.S. sales of $413 million last year. Several times, the judge indicated she believed ImClone and Aventis should have settled when Yeda approached the company before trial to seek a deal. ``I cannot decide this based on what the economic consequences may be. That's the risk you take when you don't resolve it,'' she told the Aventis lawyer. She seemed poised to at least put the Weizmann scientists on the patent, telling one defense lawyer: ``One might wonder why you didn't put the Weizmann people on your patent in the first place.'' Schlessinger is credited with providing an antibody that, when combined with chemotherapy drugs, sometimes has stopped cancer from growing. But aside from the antibody, ``everything else was ours,'' said Sela, the former president of Weizmann and the inventor of the most widely used drug for treating multiple sclerosis. He said it was the other researchers -- and not Schlessinger -- who came up with the idea to combine the antibody with the chemotherapy medication -- which served as the framework for the invention of Erbitux. Sela said he had never paid much attention to patents. ``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'' that he be put on the patent. Dr. Esther Aboud-Pirak, another of the three Yeda researchers, said she was 27 years old and disinterested in patents when she did the bulk of the research work on the method. Under cross examination, Aboud-Pirak grew testy as she acknowledged that each of the three researchers could share in any money Yeda receives as a result of the litigation. ``I don't think anybody spoke about money here,'' she said. ``We are speaking about our rights to be the author of the work that we have done.'' Schlessinger testified that he contributed little to a 1988 paper Aboud-Pirak wrote on the successful tests. And he acknowledged that his antibody was made with a cell line taken from the Weizmann Institute. The doctor said he acted properly though. ``We provided the conceptual foundation for the entire field,'' he said. ``We have really generated the only unique material here.'' George Badenoch, a lawyer for ImClone, told the judge that Yeda did nothing to pursue the claim from 1988 -- when the researchers wrote a paper on the subject -- to several years ago, after they learned a patent was issued in 2001. ``It's not proper now that we have got a blockbuster product for them to come in and say, `Hey, now we want to participate, now we got to be paid.''' "Source":[ http://www.siliconvalley.com/mld/siliconvalley/business/industries/biotech/15084342.htm]

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