KEY ISSUES IN LIFE SCIENCES IP


can be very challenging. It can take a lot of time and effort to get the conditions right. Even if two different facilities use the same protocol a process that works in one may not work in the other, as the conditions may vary slightly. In such case the protocol will require further optimisation.


Paranavitane: It intensive.


is certainly more labour-


Taking action Essex: How would a biologic v biosimilar action go in the UK? What would the examiners look at?


Jane Wainwright


Essex: Are they very complicated structures? Is that what is difficult—more work in the laboratory?


Wainwright: It depends on the particular case.


Paranavitane: Quite often you’re relying on other organisms, such as bacteria, to make a particular protein. So depending on the strain and method employed, you may have different structures resulting from the protein mis- folding, for example, or something else different about it that may affect its efficacy.


Chapman: Scale-up and purification are not the same as for small molecules. That is absolutely the case. They might be able to make something on the bench, but then having the facilities to make it large-scale is never straightforward. It requires specialists to do that.


Essex: Who does this work? Is it the big pharmaceutical companies or does it tend to be smaller companies, universities and so on?


Chapman: The small to medium level of production of biologics is by the small to medium biotechs. But as soon as you get into big-scale and real commercial scale then you see organisations contract out production. There are also some other things you see, such as big pharma companies buying up small companies so they can take what they have, expand their facilities and produce these biologics in much larger quantities.


Essex: Are there plenty of people who can do this? It seems incredibly specialised so I can’t imagine there are many people working in the area.


14


“It is more effort to keep bacteria alive and produce biologics than it is to set a reactor running to produce particular chemicals.”


Jane Wainwright


Paranavitane: Certainly in Cambridge there are start-up companies with an initial round of funding that have close links with the university.


Wainwright: It is relatively specialist, but anybody who comes out of university with a biotechnology or biological genetics background has the skills to do it. It is the same as any specialist manufacturing area. You don’t necessarily have the skills immediately coming from university, but you can learn them from people who do have a strong background.


Essex: The impression I get is that this is more complicated than working with


traditional


pharmaceutical drugs, so you will need a much higher level of expertise. Or is it just about having a degree in biology rather than chemistry?


Wainwright: Fundamentally, that is probably it. It is more effort to keep bacteria alive and produce biologics than it is to set a reactor running to produce particular chemicals.


Duch: Scaling up a biotechnological process Life Sciences Intellectual Property Review Roundtable


England: The big challenge in litigation is the same as it is for traditional small molecule drugs. You have to have good expert evidence. These cases turn generally on the quality of the expert evidence you have, and the big challenge for the legal team, as I think it always is, is from the very beginning of the case finding someone from the universities who understands the technology and who supports the case you want to make.


These cases can take two or three experts, maybe more, and that typically requires a lot of work and quite lengthy reports. It is the quality of that evidence, the persuasiveness of the expert and how credible they are that is going to turn the case. That has always been the issue, but perhaps with the diversity now, the way that science diversifies, the way that more people specialise in different things, it is difficult to get a good expert. I think that is going to get more difficult in biologics.


Once upon a time, with small-molecule


cases, you’d get a formulator who was used to formulating all sorts of drugs; typically someone who is used to making dosage forms and someone who is an expert on how these things are delivered and how they behave in the body. But with biologics, I think, you’re going to find more and more people with a particular expertise in the very specific drug that you are talking about.


That is going to be a big challenge and it is going to be expensive and difficult for legal teams. That is one of the pressures on litigation.


Essex: Do the judges generally have the knowledge to make the correct decision?


Stothers: They do; we go out of our way in the UK to recruit judges to our patent court with a technical background. They don’t need to be experts but they need to understand and analyse critically the expert evidence they are given. As PE said, it is important that the expert evidence they are getting is good, but also that the judges can understand it, and partly that is a reflection of the judge’s legal and technical background.


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