Scientific Update consultants are regularly asked to work as expert witnesses and to assist clients and their legal teams in developing cases involving patent disputes on process patents, polymorphism issues and related matters. Validity and infringement of patents are constantly being addressed and our consultants have worked on cases in USA, Canada, UK, Ireland, Holland, Norway, Denmark, Finland, Israel, Thailand, Philippines and Australia over the past few years. Most of these cases involve the pharmaceutical industry particularly when patent expiry is due and generic competition is imminent. We have worked with both multinational pharma companies and with generic companies.
An article by Trevor Laird “What makes a good expert witness,” which gives more details, can be viewed below.
What makes a good expert witness?
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.
Academic or industrial experts?
Other legal teams take the view that, for certain types of patent dispute, particularly process patents, it helps to have an expert witness who is much more familiar with industrial processes, and the procedures and protocols involved. An understanding of how the process was originally developed, optimised, scaled up, etc. may also be a useful attribute in an expert witness. Industrial process chemists are usually either still working for their companies (and therefore not regarded as independent, nor are they readily available) or have long since retired, in which case their expertise may not have been kept up-to-date. We, at Scientific Update LLP, along with a small number of other independent consultants, are unusual in having wide expertise in process chemistry/engineering (which we are continually updating) along with complete independence and, usually, ready availability. This may explain why our consultants are often in demand for legal work as expert witnesses.
One other reason may be the level of commitment that is given when an opinion is sought. Our experts are totally focused on the case and are not distracted by the demands of academic research. Our wide knowledge of industrial processes is backed up by a collection of case studies, many of which have been presented at conferences that we have initiated and organised on the subject of organic process R&D, scale-up and manufacture, the focus of many patent disputes.
Is expertise measured only by publication record?
One of the possible disadvantages of using an industrial expert rather than a well-known academic professor is that the academic can more easily be seen to be expert, with an extensive publication record and a focus on research, teaching and education. However, many independent industrial consultants are involved as advisors on R&D, particularly process R&D, with major industrial multinationals, or more heavily involved with emerging biotechnology companies that rely more and more on ‘outsourced’ expertise as their products move from the discovery phase into larger scale, where scale-up and manufacture (in which those emerging companies have little experience) becomes increasingly important.
These are often key issues in process patents, which are increasingly being challenged in the courts. Industrial experts are more familiar with the ‘process’ of obtaining patents and the background work that goes into the experimentation necessary to provide substance to the claims. Many consultants, such as myself, are also visiting professors at universities, teaching courses there. They also avidly read the literature and keep up to date with current developments both in academia and industry.
Quality of patents and experimental records
One of the reasons for the failure to be able to provide adequate laboratory notebook pages describing key experiments may be that the records have been misplaced during repeated mergers and acquisitions, closures of sites, transfer of staff to new locations, and/or early retirement of senior staff. This is a cautionary tale for upper management.
Another reason may be that, when an important piece of research or development is carried out, there may be insufficient summary reports of, say, three to six months of R&D work, which contain detailed references (in tables) to laboratory notebooks, so that a clear paper trail of how discoveries were made, evaluated and developed exists. This helps to track back to the key experiments involved in the discovery of the substance or the new process. In contrast, in generic companies, which are inevitably focused on patent issues, particularly patent busting (as it is often called), the scientists are more aware of the importance of accurate records and reproducibility.
One interesting case a few years ago involved discussions over the reproducibility of experiments. It is quite common for experiments that have originally been carried out by research students in a university and published in a reputable journal to be difficult to reproduce exactly, without using some extra knowledge or ‘tweaking’ the reaction conditions in some way. This is partly because students are, in the main, not taught how to record enough vital information, and experimental write-ups in journals, which derive from those student notebooks, are necessarily brief.
In the academic laboratory, the work may have been carried out by only one person. In industry, particularly in process departments, experiments are tested for reproducibility, for robustness (reproducibility in different laboratories by different workers under slightly different conditions, such as different sources of reagents) and for scalability, so in general (particularly procedures reported in Organic Process R&D journal), industrial experiments should be easy to repeat. The whole purpose of patent examples is that they should be written in sufficient detail to be reproduced by a person skilled in the art, but often it is not quite as simple as it looks, and this is where disputes arise.
In this case, the patent reported a method for carrying out a procedure, but this could not be repeated at two different academic institutions, one of which was the laboratory of a Nobel prize winner, and the validity of the patent was therefore in question. Despite the outstanding academic credentials and records of the professors, the work to reproduce the industrial procedure was carried out in a less than diligent manner (probably by some poor student who was assigned the work but not adequately supervised) and, in court, this was shown, after expert testimony about how the procedure should have been carried out, to be a less than fair attempt at reproduction. Later, the procedure was reproduced in a more diligent laboratory and the validity of the patent was upheld.
Biography of the Author
Trevor Laird completed his PhD in organic chemistry in 1970 and, after post-doctoral studies, joined Imperial Chemical Industries as a research scientist. He moved on to process chemistry, and worked on development and scale-up of industrial processes. In 1979, he joined SmithKline and eventually became director of Process R&D with responsibility for production of Kg quantities of all new drugs. In 1989, he left to set up Scientific Update, which has been involved in continuing education for scientists in industry and in consultancy. The company won a Queen’s Award in 2002. Trevor is a visiting professor at University of Sussex and is editor-in-chief of the American Chemical Society journal Organic Process R&D, a journal that he helped to found in 1997.