KEY ISSUES IN LIFE SCIENCES IP


such as the EPO or the UK, or are they all roughly similar?


England: The interesting thing about the UK is that three years ago our Supreme Court ruled in HGS v Eli Lilly on a case concerning the validity of a patent for a nucleotide sequence of a gene that encodes a novel protein. In that case, the issue was industrial applicability, and the outcome tried to accurately reflect the EPO line that it was fine as long as there was a technical contribution.


The argument in those cases was largely around how plausible that technical contribution was and that seems to have set a very low threshold on the patentability of a simple isolated DNA sequence, and that seems to be the best comparison.


Paranavitane: Absolutely. It is very interesting that in the US for the past 30 years they have allowed the patenting of genes and some of those patents have now expired. In the UK we have reduced the bar to patentability by the HGS v Eli Lilly decision, but I think that was due to the influence of policy and funding/research incentives. It departs from previous legal precedent.


Wainwright: The difference between the US and Europe/UK is that we put a lot more stock in the examiners getting it right when dealing with inventiveness. We have exclusions to patentability but they are more limited than in the US. It is almost as though the US doesn’t trust its examiners to follow through and do it right, whereas we have a bit more trust in our examiners getting it right.


Essex: I love this idea that they don’t seem to trust their patent examiners.


Wainwright: Does anybody trust their patent examiners?


Personalised medicine Essex: Let’s move on to personalised medicine. If you come up with some sort of treatment for one particular person in one particular circumstance how do you protect the idea when it’s a one-off and not something you’ll use again?


Wainwright: Personalised medicine isn’t really personalised for just one person: it’s used to treat a sub-population of people with a disease. The stereotype would be the BRCA gene—lots of patients have breast cancer, but not all of them have a BRCA-related breast cancer, so the accepted treatment targets that section of the population that has that breast cancer, but not all patients. So it isn’t personal for an individual, it’s personal for a group based on the genetic marker.


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Paul 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.”


Paul England


Essex: Does it depend on how many people this is likely to be helpful for, and that would determine what it is worth?


Wainwright: Usually, yes.


Stothers: That has implications outside the patent sphere. It has big implications for the pricing of the pharmaceutical product. How do you work it out, because that price is going to be higher than the price of something that covers the whole population.


On the patent side, provided you’ve got a big enough population, it’s still going to be worth the patent cost of protecting it. There is whole a lot of pressure on the regulatory side of how you deal


with this, and how you are going to change the mechanism that controls healthcare pricing and then provides enough incentive when it includes only 30% of your population.


We’ve had these issues with things in the past where you have a small population. There are a lot of difficult economic and ethical decisions to make about how you use your limited resources to get the best results.


Chapman: Clinicians would probably say they want the best treatment for the patient and at the moment, using cancer as an example, we just have to try this drug and see if it works and if it doesn’t work then we have to move on to the next one. Personalised medicine, in that sense, is a way to tell more quickly if one drug is going to be better than another drug.


Not only does that save the NHS a lot of money but, more importantly, from the clinician’s point of view, he is able to give the right treatment earlier. With cancer sometimes you only have a two to three-month window.


If you get it wrong then that is life or death to the patient; that is why personalised medicine becomes really important for diseases such as cancer.


Life Sciences Intellectual Property Review Roundtable 7


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