01/29/2004
What are those As, Ts, Cs and Gs?
Biotechnology trials present daunting challenges for everyone involved. Not only do such trials usually involve complex areas of the law, but they also relate to highly technical concepts that most of us have not come close to seeing since our high school biology and chemistry classes. What's more, the trials tend to be enormously costly and often require management to "bet-the-company" on the outcome.
In the face of such risks and challenges, how does a biotechnology company communicate its story to an average juror, judge or arbitrator in order to win a trial?
Other than hiring an experienced and effective trial lawyer and selecting the right company officer or scientist to tell the company's story at trial, perhaps the next most critical element of a biotechnology trial is finding the right expert witnesses to make your case.
Jurors, judges and arbitrators strive to reach the right result and -- especially in biotechnology cases -- must usually rely on someone else's expert opinion on subjects that are beyond their own education and training. If an expert witness can gain their respect and trust through clear communication, credentials, personal interaction and confidence in the presentation of their opinions, the case is more likely to come out in your favor.
How do jurors and judges assess the credibility of biotechnology experts? Advanced degrees in the subject are a must. It also helps for the expert to have patents of his or her own in the field, to be a published author in the field, and to have received coveted prizes and awards in the field.
However, while more is better, even the greatest credentials cannot substitute for good communication skills and personality. Expert witnesses must have the ability to make complex issues seem simple and communicate at a down-to-earth level. Without these skills the expert's testimony will likely be a waste of time, money and effort.
In a case tried during the spring of 2003, Ichor Medical Systems presented an expert witness whose resume ran approximately 35 pages and included some 700-plus patents issued to him in the fields of polymer chemistry and molecular and cellular biology, was the youngest person in history to be invited to join all the National Academies and had just received the equivalent of the Nobel prize for engineering.
Despite those imposing credentials, he had the jurors eating from his hand well before going into his substantive opinions. After trial, and after awarding Ichor approximately $14 million in damages, the jurors said that they were in awe that the expert was willing to devote his time to the trial and remarked about how effectively he shared his opinions with them.
Given the imposing subject matter they must communicate, it is particularly important in a biotechnology trial that the experts be someone the jurors can relate to. Your expert should not have any odd habits or quirky behaviors that distract the listener's focus or interest. Even a disheveled, absent-minded-professor personality may be acceptable, if the jurors like the individual. On the other hand, if they don't like your expert, it could spell doom for even the best of cases.
Recognizing the different ways through which people learn, the trial lawyer can further help the expert get the point across to the jury by conducting "show-and-tell" with some actual materials used in the underlying technology.
In a biotechnology patent or trade secret case, the trial lawyers should work with the technical expert witness to develop and use a multitude of graphics and visual imagery.
The expert must simplify and distill extremely complex problems and issues into almost cartoon-like graphics. After all, a few simple, step-by-step, pictures or animations are worth a thousand long technical words.
Similarly, the trial lawyer and expert should look for ways to prepare 3-D models that the expert can hold and display at appropriate times during the testimony. The use of models also can provide lasting benefits throughout trial as their presence on counsel or exhibit tables can serve as a subtle but lasting reminder to the jury of the expert's testimony and opinions.
For example, in another recent biotechnology patent trial, one of the technical experts used a 3-D model of a nucleic acid sequence to demonstrate the complementary nature of the sequences. While they admitted to having been intimidated by the subject matter at first, the jurors told us that the model put them at ease because it resembled a kindergartener's wooden building blocks.
The trial lawyer should also work with the expert to avoid having the trial becoming mired in an alphabet soup of complex and confusing terminology. Biotechnology cases invariably involve a discussion of nucleic acid technology, so in the course of the expert's introductory tutorial, it may be worthwhile for the expert to refer to the base units of DNA by their full names: adenine, thymine, cytosine and guanine, at least once.
However, repeated references to the full technical names may only serve to confuse the jury. Instead, the expert can simply refer to them as "As", "Ts", "Cs" and "Gs" without butchering the science.
Delivery and substantial proof of the expert's opinion is also a vital component of an effective witness. Under recent U.S. Supreme Court case law and rules, trial courts are obligated to scrutinize expert witness testimony and act as a "gatekeeper" to ensure that junk science and unqualified expert opinions do not get offered to the jury. For the year 2000, a Federal Judicial Center Survey revealed that only 59 percent of federal judges allowed the jury to hear expert testimony without any limitations and 42 percent excluded testimony because they found the expert witness was not qualified to offer the opinion.
In preparation for the trial, the expert's opinion must be firm, unqualified, unwavering and well-grounded in relevant science.
The expert must not only confidently deliver an opinion, but must also explain the rationale for why the opinion is correct. What peer-reviewed studies corroborate the opinion? How are all facts reconciled with the opinion? What empirical evidence supports the opinion? Has the expert considered all the facts, or was there some "selectivity?"
In the face of these demanding criteria, how does a trial lawyer find capable and acceptable expert witnesses?
To begin with, company scientists should be the first people you ask for suggestions. We are often surprised at how few "degrees of separation" exist between our clients and some of the most respected scientists throughout the world.
Second, look to the departments of leading colleges and universities which typically employ an abundance of experts in virtually every scientific field. Also, don't ignore literature searches that will identify those who have published or invented in your field. Authors of critical prior art may be particularly persuasive both for -- and against -- patentees.
Expert witnesses in biotechnology trials are critical. You can't win without them, but unless they are properly prepared, properly qualified and able to communicate effectively and persuasively, you may not win with them.