KEY ISSUES IN LIFE SCIENCES IP


Biotech Directive. So there has been a complete role reversal.


Essex: Does this mean that researchers are not going to try to develop a breast cancer therapy? Does it mean that there is not going to be any more research in that area because what is the point of doing the research if you can’t patent it?


Wainwright: I don’t think it’ll mean no research, but it might skew who does the research. The USPTO guidelines, if they are implemented and ultimately supported by the Supreme Court, are going to make it difficult for academia and small biotech to pursue protection, because they don’t have the funds to take things much further.


Big pharma will be less impacted. They can afford to keep things going a lot further. It will influence who does the research and therefore that will affect what research is done.


Varuni Paranavitane


Varuni Paranavitane: Surely, the USPTO could be challenged. The US Supreme Court decision itself is a nuanced decision that actually brings the law of patentable subject matter in line with the EU position. It appears that the USPTO has gone beyond that. And while I can’t speak for the US legal system, presumably it can be challenged in a higher court.


Chapman: There has been a precedent in the past where the US introduced rules in relation to certain things. If it has laid down rules, it can be challenged over whether it has the right to make those rules. But these are guidelines—they are not statute. They are just there to assist examiners in understanding cases. And I don’t know how challengeable that is.


Wainwright: I have certainly read nothing that suggests the guidelines themselves can be challenged. It is going to require somebody who has had a patent refused to take their case through the court system and get a decision.


Paranavitane: Absolutely. That is what would happen in the UK, for instance.


Rules or guidelines?


Essex: But these aren’t what I think of as guidelines. These seem to be rules.


Wainwright: The USPTO would argue that they are guidelines.


Paul England: They are effectively rules, I suppose, because they reflect what the USPTO will do. What I find interesting is that the guidelines reflect and expand on the logic of the ruling


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“The US Supreme Court decision itself is a nuanced decision that actually brings the law of patentable subject matter in line with the EU position.”


Varuni Paranavitane


in the case. I am looking at it in a different way, and my question as a lawyer is will the Supreme Court in later cases follow its own logic and fill out those guidelines? That is one of the big risks for patentees.


It is very interesting to me, because many years ago I worked on the Human Genome Project and as you may know at that time there were two rival camps working to sequence the human genome. In one was the publicly funded research facilities around the world and in the other were commercial organisations. There was a perception, probably mythological, that the businesses were effectively sequencing, chopping off sequences and putting them in a patent and sending it off the USPTO.


There was a fear that property would be lost. But now the position appears to have been reversed. If my understanding of it, as a lawyer, is right, the US position is somewhat more restrictive now than the UK position, and I think the European Patent Office’s (EPO’s) as well, in terms of Article 5 of the


Life Sciences Intellectual Property Review Roundtable


Essex: If you were big pharma, would you put seven years of work into something and then not get a patent at the end?


Wainwright: They are more likely to keep it going to the point where they would be able to protect something.


Chapman: The arguments that have been put on record are the ones that I dislike the most. They are the emotional arguments: that it is going to stymie US research. The better arguments have addressed the law and have said that it has been interpreted or adopted incorrectly.


You can see some lawmakers saying it is all about the law and you shouldn’t be swayed by emotion and just say ‘this is going to stymie US research’ although, of course, a lot of people are going to say just that.


I can see another side of the argument, which says ‘that is not the way you should be looking at this’. I am happy to see that some people ha ve been very careful and raised that as part of their arguments, but then they have very carefully moved on and looked at the law.


Essex: Can you argue from both the legal and the ethical point of view?


Chapman: Absolutely.


England: I'd be cautious about assertions I have read that it will lead to an exodus of research from the US because, in fact, it really makes no difference where you’re located. What it makes a difference to is whether you have a monopoly market. So the real impact on research is on anyone who wants to patent, whether they are US or Europe-based.


It cuts off, to some extent, a market for those www.lifesciencesipreview.com


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