KEY ISSUES IN LIFE SCIENCES IP


England: There has been at least one. They would go the same way as any other patent action. The difficulty with biologics comes down to the subject matter and the scope of


the claim—it


depends on the breadth of the claim. That is the kind of issue that is particular to biologics.


Essex: So why is there a biologics patent cliff?


England: The classic example is the HGS v Eli Lilly case, which concerned a patent for a gene sequence of the tumor necrosis factor (TNF) protein and the antibodies to it. That is a very broad patent. The challenge failed to have it invalidated and that case demonstrates you can have a very broad patent that effectively stops anyone using TNF and antibodies to it. So you can certainly have biologics patents. They are not new; they have been around for about 30 years.


Essex: So is it just the media that talk about a patent cliff and you don’t? Or does it mean that many patents are about to expire and that therefore there will be more scope for biosimilars?


Wainwright: That is the conventional meaning, but it’s usually applied to pharmaceuticals. I haven’t heard it being applied specifically to biologics.


Stothers: I agree. 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. On the other hand, I think there is going to be a lot more biosimilar/biologic patent litigation in the next few years.


I’m not sure the standard patent cliff is interesting. What is interesting is biosimilars coming on to


12


“You’re not just saying that it’s a different size or a different colour so it’s not similar.”


Chris Stothers


the market and then there actually being a real question. HGS v Eli Lilly was interesting because the similar product was a long way from the market and it was about trying to clear the way in time.


Eli Lilly was trying to clear a path for its molecule to get onto the market and it was not the traditional generic case; normally a company would not try to clear things quite so far in advance as Eli Lilly tried to.


England: It is not all or nothing. It is not simply a question of the patent expiring and then open competition. It is the patents that are referred to as secondary patents, or pejoratively referred to as ‘evergreen’ patents, that are usually the ones that are going to be fought over. And they will still generally exist after the initial patent has expired. So the makers of biosimilars will need to get around those if they want to use the same formulations—much like traditional pharma, where there will be a patent portfolio around the original patent for the sequence.


Essex: So it is very similar to brands v generics? There is no difference except that these are more complicated structures?


Life Sciences Intellectual Property Review Roundtable


Stothers: You don’t have that same problem with generics, because the generic is the same thing. It is what is covered. The Eli Lilly case in the Supreme Court suggests ‘Don’t try it; we’re going to maintain these patents in the UK. Go after the secondary ones if you want, but don’t come after the sequence one.’ That seems to be the message, but I’m really reading between the lines.


Paranavitane: Unless the biosimilar is so different from the biologic that it does not fall within the scope of the biologic subject matter.


Essex: That is what I was thinking. The generic has exactly the same chemical composition as the branded drug. Does the biosimilar not have exactly the same molecular structure as the biologic?


Wainwright: No. England: No.


Wainwright: Hence it’s not a biogeneric, but a biosimilar because it is almost the same.


Essex: So the discussion is about how similar it is and how different it is.


Wainwright: Yes. In some cases a biosimilar could be quite different, but still fall within the claim scope. In other cases, the claim scope can be relatively narrow and a biosimilar could be very similar but not fall within the scope.


Stothers: There could be an interesting clash between the regulatory process, where the biosimilar maker says ‘we’re really, really similar, so don’t make us do lots of difficult tests. Let us on to the market with minimal additional testing’,


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