KEY ISSUES IN LIFE SCIENCES IP


Chapman: The law was not drafted very well in the first place.


Wainwright: It has never been fit for purpose.


Chapman: That is what it comes down to in a nutshell.


England: One big issue in SPCs that illustrates the problem came from a case called Neurim. It was always understood, until recently, that an SPC could only protect a product that was protected by a patent. After Neurim, the Court of Justice of the EU (CJEU) adopted a fresh way of interpreting the regulation on SPCs. Part of that fresh way of interpreting it was that you could then get an SPC for a second medical use of a product. That was completely new.


Paul England


England: You can with a European patent, but not with the unitary patent.


Wainwright: But you will still have the option open to you to file in those countries separately.


Stothers: There is quite a long transitional period, so at


the moment you have to decide


whether to opt for a unitary patent everywhere or choose in which country you want to patent. In future, the fees are going to be crucial because the litigators and the patent prosecutors who advise on strategy, and the people who are paying for it as well, will say ‘if the cost differential is large, we’ll file more of the cheaper ones than the expensive ones that are better strategically but twice the price, or three times the price’.


Wainwright: It very much depends on the applicant. If they are interested in only three countries—say the UK, Germany and France— then there is no point in their paying a fortune for unitary patent cover for every single European state, including ones they have no interest in. The renewal fees are clearly going to be higher. Not everybody is going to be interested in it.


They are going to be interested if they think they might go into all those countries, so let’s just do it in one shot. It very much comes down to business strategies for each individual applicant.


Essex: Might any of the others close down?


England: No, it will run parallel with the existing system. Chris was talking about the transitional period, and after the transitional period the


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“My question as a lawyer is will the Supreme Court in later cases follow its own logic and fill out those guidelines?”


Paul England


European patent must be litigated in the UPC, unless you’ve opted out. If you’ve opted out a patent for its entire life, 20 years, then that is some way off. There is a big question at the moment: who will opt out, how many people will opt out, how many people will stay in the system, how many people will get unitary patents?


It comes down to case by case. What is the product, what is the market, how much is it going to cost, what is the risk of its being attacked, how strong is the patent? All of those factors are going to be part of the decision for every patent.


Chapman: And there was a threat that on the day it came into force people would instantly try and attack the patent and knock it out. So there has to be a sunrise period.


Issues with SPCs Essex: Supplementary protection certificates (SPCs). What is the CJEU thinking about?


Life Sciences Intellectual Property Review Roundtable


It goes against all previous authorities, including themselves, and it led at least one UK judge to exclaim in exasperation that something needed to be done. There has been a dissatisfaction in the UK court with some of the decisions coming from the CJEU. And the problem appears to be that there is a lack of consistency in the decisions they are making. That has led to new calls for the re-drafting of the regulation.


Chapman: Do you think there will be a re-drafting?


Wainwright: That would require them to admit that they were wrong in the first place.


England: I hate to go back to the UPC, but it needs to be re-drafted if we’re going to get SPCs on our unitary patents. That decision on Neurim appears to have had a line drawn around it. That was a special case but, nonetheless, there is a lack of consistency.


Stothers: There is a problem with these cases. I was looking at the statistics overall for SPCs and most go through and very few are challenged. A handful end up in a mess and the CJEU ends up in a real mess on those, but saying the SPC system doesn’t work at all I don’t think is entirely right. For a lot of products it works fine, and there are some where there are issues the people drafting them did not think about.


In the UK we’re very focused on it because a lot of the references come from the UK and that is in part because judges are very willing to refer cases and be rude about what the CJEU has done previously. Whether that is a clever way to get the CJEU to be helpful to answer your questions is to be seen, but it doesn’t appear to be working very well so far. There is only a very small number of SPCs and most that go through get granted and protected for the lifetime that they are required to protect.


We get over-excited about the system being www.lifesciencesipreview.com


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