Life sciences patent cases typically involve complex legal, regulatory, and technical issues. Yet, they often are presided over by judges with little patent experience, and with even less experience handling life sciences regulatory and technical issues. It is, therefore, critically important to develop creative ways to educate the judge about such issues during the entire pendency of a case, including trial. Sige Gutman discusses the importance of playing the role of educator to the judge.
Siegmund Gutman: In any case that you intend to take to trial, it's obviously very important that both the judge and the jury understand the case in detail. In patent cases, that is complicated by the fact that you often appear in front of judges that have very little or no experience in patent cases, which is exacerbated by the fact that, when you have a life sciences case, which is usually one of the more complicated sort of cases, the judge will not have any experience dealing with life sciences patent cases. So it's especially important in that context to think about creative ways to deliver that information to the judge.
Consider creative ways of delivering complex information to the judge.
Siegmund Gutman, Partner, Life Sciences Patent Practice
One example of a case that I litigated where these issues came up was between two very large biotechnology companies in a matter that addressed an antibody cancer drug, as well as a lot of other technological issues. The legal issues were also very complicated, because they spanned the full spectrum of patent issues and also intersected with FDA regulatory issues. So it was important with the judge that we were dealing with in that case, that had very little experience in patent cases, to be able to explain the patent law that was at issue in the case, how it related to FDA regulations, and be able to apply all of that to complex technical issues that were foreign to the judge. And that really highlights the importance of taking your time throughout a case in order to connect with the judge and come across as a teacher to the judge in order to explain not just the basic patent legal principles but really the nuances surrounding those principles.
You don't want to overload the judge in one sitting and present too much information. You really want to spread the information out over the course of the entire case during discovery conferences, during status conferences and allow the judge to digest the information and be ready for the next installment of information, which might precipitate a good exchange with the judge and reinforce your role as educating the judge.