Scientific Update Consulting have, over the last 11 years, been involved as expert witnesses in many court cases (in the US, UK, continental Europe, Asia and Australia) involving patent disputes, mostly between major multinational pharmaceutical companies and generics. Often it is the multinational pharmaceutical companies that are trying to hold on to exclusivity for their blockbuster patents or to extend the patent life by use of ‘innovative’ process patents or novel solid drug forms. In contrast, the generics are seeking to circumvent these patents, though they also usually make counterclaims regarding validity, often with reasonable justification.

We have been involved as expert witnesses in cases where the patent holder is seeking to prove infringement and where we believe that infringement has clearly taken place. But we have also been involved in several cases, usually involving a generic company, where we believe that the generic company is not infringing the claims of the existing patent and should be allowed to market a generic form of the drug using a novel process. Occasionally, we have been able to provide expert testimony that has clearly demonstrated the reasons why the original claims of an inventor’s patent should be invalidated.

Cases are on a knife edge 

Most cases in which we are involved are on a knife edge. It is easy for an independent person to see both sides of the argument, and judges (or occasionally juries), many of whom have no scientific background, have a difficult job in formulating a closely argued verdict (which of course may be overturned on appeal). I am always impressed by the ability of lawyers and judges to grasp the intricacies of extremely complex scientific arguments that may need to be fully understood before an accurate judgment can be made.

Of course, how well the legal team and, perhaps more importantly, the judge becomes acquainted with the scientific arguments will depend on the reports, and the affidavits of the expert witnesses and their performance in court under cross-examination. A fundamental role of the expert witness must be in educating the bench in understanding the background science, in effect, giving a tutorial focusing on the science as well as the key issues in the case, and explaining these as far as possible in lay man’s terms, without trivialising. The expert must also be able to perform in court under pressure from hostile cross-examination and to remain calm in all circumstances, whilst delivering clear statements without filibustering.