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Published on 13 June 2007

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Repligen gains in Erbitux dispute

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Repligen has won a major battle in its long-running patent dispute with rival ImClone Systems over the blockbuster cancer drug Erbitux® (cetuximab) after lawyers for the latter firm were found to have acted in an intimidatory manner to a witness key to the case.

A US District Court has issued a favourable ruling on the sanctions motion filed by Repligen and Massachusetts Institute of Technology against ImClone, based on conduct that “constituted intimidation of a central witness in the Erbitux patent infringement case”. The court said the actions of ImClone’s counsel were intended to block the cooperation of key witness Dr Stephen Gillies, inventor of the patented product, and that these actions prejudiced Repligen and MIT from fully prosecuting their case.

Repligen and MIT complained that ImClone’s outside lawyer Paul Richter and its in-house counsel, Tom Gallagher, intimidated Dr Gillies during questioning and by contacting his current employer, is Merck & Co. After being questioned the scientist told MIT he no longer wanted to testify.

Judge Richard Stearns said jurors may be told about the attempts to deter Dr Gillies from testifying, and awarded MIT “reasonable” attorney fees and costs. Mr Gallagher was sanctioned by the judge who added that “the questioning was undertaken as part of a deliberate stratagem to deprive MIT of Dr Gillies’ services as an expert witness”. Meantime, ImClone has replaced its in-house and external patent litigation teams, saying that “we respect the decision of the court and look forward to defending the case on its merits at trial”.

The trial date, now set for September, is the culmination of a dispute begun in May 2004 when MIT and Repligen sued ImClone, claiming the latter used patented genetic elements that increase protein production in Erbitux, which had sales of $1.1bn last year. MIT holds the patent on the aforementioned elements and licensed its use exclusively to Repligen; both organisations are seeking damages.

Repligen chief executive Walter Herlihy said: “We are pleased that the court has given us relief for this misconduct and has set the case for trial”. His firm would certainly appear to be in the driving seat. Some analysts feel an out-of-court settlement may be in the offing from ImClone.

The court’s ruling came a day after ImClone and partner Bristol-Myers Squibb declared that the FDA has granted a priority review of their supplemental biologics licence application for Erbitux. The firms said they hoped to include evidence of improved overall survival in the product labelling for the drug in third-line treatment of patients with metastatic colorectal cancer. A decision on the application is expected in early October.

PharmaTimes 13/6/2007

 



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