Repligen Corp has won a major battle in its long-running patent dispute with rival ImClone Systems over the blockbuster cancer drug Erbitux 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 the Massachusetts Institute of Technology against ImClone based on conduct that “constituted intimidation of a central witness in the Erbitux (cetuximab) patent infringement case. The court said that the actions of ImClone's counsel were intended to block the cooperation of a key witness, Stephen Gillies (the 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 of Kenyon & Kenyon, and its in-house counsel, Tom Gallagher, intimidated Dr Gillies during questioning and by contacting his current employer, which is Merck & Co. After being questioned, the scientist told MIT he did not want to testify anymore.

Judge Richard Stearns said that jurors may be told about the attempts to deter Dr Gillies from testifying and he also 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".

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

Repligen’s 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," and his firm would certainly appear to be in the driving seat. Indeed some analysts feel that an out-of-court settlement may be in the offing from ImClone.

ImClone, B-MS seek to expand Erbitux use

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