KEY ISSUES IN LIFE SCIENCES IP


That is why the UK is a good place to litigate: the judges do have sufficient technical knowledge to understand the evidence. I’m sure everyone has cases they can think of where they think the judge didn’t understand it, but it is impossible to have a technical-specialist judge within every specific field of biology. So you need to have some way of bridging that.


I do feel very sorry for judges who aren’t specialists who have a legal background and don’t understand the science and have to decide these cases. It’s going to be very difficult and you’re going to get very wild decisions for quite a while. So it’ll be interesting to see if people choose the UK as a base to litigate for this kind of case or say ‘let’s go for a country where we get a judge with no technical understanding and let’s see what they make of it’. People do not always decide these strategies necessarily on where they can get the best judge.


England: Before the judge is allocated to a case, the case is given a technical rating. The most difficult cases are always allocated to the same pool of judges, both in the patents court and the court of appeal—judges who are experts and began life as scientists with science degrees. Generally they are excellent at understanding this. I have never experienced a situation in which the judge had difficulty understanding the technology.


As you go forward to the Unified Patent Court (UPC), that is an issue that is going to have to be addressed by appointing dedicated technical judges because that technical issue has been recognised. The UPC system is set up so we have legally- qualified judges and technically qualified judges and both will sit on panels deciding cases and inform each other and come to a decision, because the technology in science in these cases is so critical.


Wainwright: One of the nice things about the UK judges is not only that they have a technical background, but they actually put in the time and the effort needed to understand a case. So even if it’s not from their technical background they will make the effort to understand it almost as well as you do. That is a big difference as well when you get the non-technically qualified judges in other jurisdictions—because they know they are never really going to understand it they are not going to make as much effort to try.


Essex: So does the UK have a good reputation? Wainwright: I think so.


Essex: The idea that you choose to prosecute either in a place where they have the knowledge or in one where they don’t is interesting.


Paranavitane: That is a question of strategy. www.lifesciencesipreview.com Varuni Paranavitane


“In the CJEU, there is a representative of every EU state and each will have a voice. The judgment is an amalgam.”


Varuni Paranavitane


Essex: In which other places do judges have the expertise?


England: Germany, the Netherlands and France all do; they have judges that can understand these cases. There are others, too.


Chapman: As you say (PE), if a lot of this is going to turn on experts then other jurisdictions do not all have the expert testimony that we have. Strategy can come into play a lot more as biologics cases move forward.


Unified matters Essex: What else is vexing you all at the moment?


England: The UPC. That is always the elephant in the room. It comes into everything now. The UPC is possibly as little as two years away and is going to the biggest transformation, disruption if you like, to the patent system in 40 years. Everyone—lawyers, patent attorneys, in-house counsel—needs to start thinking ahead in terms of their strategies. Two years is not a long time in


business to start thinking ahead about how they are going to negotiate the new system.


Wainwright: The difficulty is nobody knows what the system is actually going to look like. It is very difficult to know how you can navigate it and advise clients.


England: The big unknowns are costs and fees. The rules are nearly there, so the big picture I think is there. Cost is the huge factor that is holding everyone up.


Essex: Would you always want a unitary patent or would you choose something else if you only wanted to cover, say, three countries?


Chapman: With biotech and pharma, I am not convinced they are going to use the system.


Wainwright: It is very much going to depend on individual applicants.


Essex: Why would it make a difference if you were in biotech or pharma?


Chapman: With pharma there are certain jurisdictions where the patent is more important to have in terms of exclusivity. If you’ve got an all-or-nothing patent that can be knocked out in court that is maybe too much of a threat. They may decide instead to keep a number of patents in certain jurisdictions.


Paranavitane: It is possible to opt out, see how things go and then opt back in.


Essex: I thought you could still choose which jurisdictions, or how many jurisdictions, to apply for?


Life Sciences Intellectual Property Review Roundtable 15


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