KEY ISSUES IN LIFE SCIENCES IP


broken. It doesn’t work very well in some areas, but it may be a question of fixing those areas rather than trying to make a wholesale change, because you introduce new problems whenever you try and change the system.


Essex: The CJEU decision should allow companies wider scope to obtain SPCs covering multiple products on the patent. Is that right?


same


Chapman: One decision says you can and the other decision says you can’t.


England: As far as simple products are concerned it’s OK, but for functional claims for antibodies etc, it is not so clear.


Chapman: It is a grey area. But to come back to biologics, I can see more litigation happening. With a biologic you need to have an SPC that says for example ‘anti-TFN antibody’, because if you actually call it by its name then the biosimilar is going to say that it is not that product any more and so is not covered by the SPC. So it’s going to be incumbent on the originators to try and have the broadest product definition they can for an SPC and then push the patent office which says ‘you can’t do that, because it is meant to be just a product.’ I can see more fighting about that.


England: Looping back to personalised medicine, there is another interesting question about SPCs. As I said, after that Neurim decision we now know you can have an SPC for a second medical indication. Can you have an SPC on a product that can potentially treat a small population that was previously treating a larger population of people? Is that essentially a new medical indication? I think that is going to be an interesting question for personalised medicine protection.


Essex: It seems the CJEU has answered some questions, but actually raised others.


Wainwright: There is another point about the CJEU that brings us back to the unitary patent as well. They are going to be the ultimate appeal court for the unitary patent system and we know that they are basically incapable of giving out consistent decisions on patent-related matters in the form of SPCs. So how on earth are they going to be able to give us authoritative decisions on regular patent litigation?


Conlon: Why do you think there is so much inconsistency?


Wainwright: Probably because they are not technically qualified.


Paranavitane: Also, in the UK, you’d have one leading judgment given by one person who is transmitting the views of the others. In the CJEU,


www.lifesciencesipreview.com


Chris Stothers


“It is all very well having patents over a biological but if there is no biosimilar that has been authorised in the market it is just a piece of paper.”


Chris Stothers


there is a representative of every EU state and each will have a voice. The judgment is an amalgam.


Stothers: The CJEU approach is meant to be deciding the questions referred to it. It’s not really quite the same role as the Supreme Court in the UK, where the court is meant to be laying down the law generally and that is why it has taken this case on. The CJEU’s role is meant to make a decision on the questions raised to it. Unless the questions come up in the right order, then you can understand why they end up giving divergent decisions.


It is very frustrating in the UK because we look to them and want them to tell us what the answer is. And they say ‘we told you the answer to that question but you’ve got a question that is very similar; it is not the same question but we’ll give you another answer to that too.’


I can’t imagine our Supreme Court doing that. They will take a case because they want to give us


a particular steer, as in HGS V Eli Lilly, where it was clear that they wanted to make this general point that these early-stage biologic patents should be valid and shouldn’t be struck out on industrial applicability.


The CJEU does not get to choose its cases; it is forced to hear all the cases that come before it.


It sometimes says ‘we’ve decided all of this before— it’s not a new question’. They’ve done this on SPC cases. So they think that giving such clarity means they don’t even need to give full judgments, even though everyone in the UK says ‘no you’re not’.


Essex: So the judges can come from anywhere? You can get a judge from a small country who doesn’t know anything about the subject?


Stothers: There is one judge from each country. A particular chamber will have a number of judges. They don’t need to have specialisations. In some legal traditions, judges will be academics who have never practised law or a technical field. They have to decide all sorts of cases, including VAT and customs duty—all sorts of stuff that has nothing to do with patents.


Chapman: It brings us back to the Supreme Court and the questions we were having at the beginning. People making decisions that they might not be qualified to make.


Essex: So on that note I must end the discussion as we’ve run out of time. Thank you to everybody and I look forward to our next meeting to talk about the key issues in life sciences IP today. n


Life Sciences Intellectual Property Review Roundtable 17


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