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KEY ISSUES IN LIFE SCIENCES IP


and the patent case, where they will be saying something completely different: ‘we’re nothing like the original biologic, so we shouldn’t be caught by this patent’. There is going to be an interesting clash there, particularly because a lot of companies don’t join up those departments particularly well.


Chapman: Do you think there might be cases where someone has a so-called biobetter, which has an antibody that is six times as good as the biologic’s, and yet is caught by the biologic’s patent? Do you think there will be cases where people try and challenge the breadth of the claims?


Stothers: I’m sure that will happen and you get the sense of that from Lord Justice Jacob’s comments on Eli Lilly, where he said that in some cases there will be compulsory licensing. I think generally the view is that this is unlikely to be followed, but it shows the kind of reaction to exactly that situation. Forget generics because generics do the same, not six times better.


With these cases there will be a concern eventually that better products are being kept off the market for a period of time, so I’m sure people will try it.


England: The risk you run if you’re developing a product that is better is, of course, that you have to back that up with your own clinical trials. On the one hand, you can try and save some money by getting an abridged application for regulatory approval and not have to do your own extensive clinical trials, or you can do the trials and avoid infringement, but then you have to pay.


Chapman: But if your bio is better, then your chances of taking over the market are much, much higher than with a generic. The starting drug always


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“Even if two different facilities use the same protocol a process that works in one may not work in the other.”


Anna Duch


seems to keep on in the market even though there is generic competition. In a biobetter situation you can see the original biologic losing its market.


Essex: I haven’t heard the term ‘biobetter’ before. Is it in common use?


Chapman: Yes.


England (to Chapman): How do you understand the term biobetter? It is one of those words that gets bandied about.


Chapman: We’re all struggling to get to an accepted meaning of biobetter. It is horses for courses; it is whatever you want it to mean. I guess it just means that you’re going to have to argue that there is something better about it. Perhaps they are the same thing. But mine might have a different formulation that could reduce the number of times you have to administer the drug. There is a big advantage in that.


Interestingly, we were talking about patient compliance and changing the amount of times you administer a drug. There is a company, I heard, that was making a big play of a formulation that


you need to take only once a week. The existing drug is taken once a day and normally you would think that only having to take a drug once a week is good. But the once-a-day company was actually arguing it did not feel threatened because patients were more likely to take a drug once a day, because it is more difficult to remember to take it once a week. I actually saw that argument and thought they had a good point.


But normally with a biologic, which has to be injected, once a week is clearly going to be better. I think formulation is an area that is really going to play out with biologics, even more so than with small molecules. There may be more scope for arguments about inventiveness than perhaps there is for small-molecule drugs.


England: In terms of the cases you will see in the courts as the years elapse there will be more and more biologics cases.


Essex: So are more biosimilars about to enter the market?


England: I think so, yes.


Wainwright: But it is still a market in its infancy. Biotechnology is a relatively new industry in comparison to the pharmaceutical industry, so it will take longer for people to get up to speed, then get the facilities and the research capability for something to reach the market. We’ve known for an awfully long time that you can copy a pharmaceutical and get it onto the market, but it is a relatively recent thing to be able to copy a biologic or make a very similar biologic in any lab without too much difficulty.


Life Sciences Intellectual Property Review Roundtable 13


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