KEY ISSUES IN LIFE SCIENCES IP


Essex: Yet venture capital and private equity is generally invested in risky assets because the riskier the investment the higher the potential returns. If your risks are higher your returns should be higher.


Wainwright: The return is always going to be the same, if there is going to be a return.


Anna Duch: There are different types of risk: the risk that can be avoided and the risk that cannot be avoided. They have a choice between investing in different fields and if they can avoid those with changing rules then why would they not do that?


Ed Conlon: Are there any similar fields within life sciences that they might invest in which would not be as risky?


Chapman: Ironically, some of them are actually investing in diagnostics. They wouldn’t go into biotech because that is going to take too long to provide a return and instead they go into diagnostics, and that perhaps has backfired. So medical devices is an obvious area they will start moving into because they can see an exit much quicker.


England: The funny thing there is that in the last


five to ten years, perhaps longer, and in Jane Wainwright


as damaging as this then that really strips away a lot of value for a lot of people.


Chapman: We had a similar situation in Europe with stem cells. But there is a difference with stem cell research in that it is recognised as a very specialised area. So even though there was a lot of fear about not being able to patent certain areas, the industry itself began to recognise that there was plenty of know-how and experience. Some companies started to realise they could carry on because of the complexity of the product.


We don’t have that with some of these natural molecules; companies don’t have that ability to hide behind the science because in theory lots of people can copy these things.


England: It highlights the risk I was talking about. There is uncertainty now about whether the Supreme Court will make similar decisions in other cases that are, strictly, outside that ruling. Will it apply the same logic to the point where the guidelines do reflect what the Supreme Court has been deciding? There will be big question marks for investors over those kinds of patents.


Paranavitane: The analogy that they used— that isolated DNA is not patentable, but complementary DNA (cDNA)


is—could 6


“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.”


Jane Wainwright


like artificially prepared insulin need to be from their naturally occuring


counterparts? What


modifications ought they have in order not to be considered identical?


be extended to biologics. How different do products


Chapman: It is slightly perverse. The cDNA in a functional sense is absolutely no different from DNA. But if a small change is made with a protein is it then marketed differently? In a functional sense it could, absolutely, be marketed in a different way. It is funny how they have made this big play on cDNA being structured differently.


Life Sciences Intellectual Property Review Roundtable


particular since the financial downturn, there has been an impetus to diversify—to biologics, to diagnostics—and that is threatening to push the industry back away from pharmaceutical molecules—from a lot of the valuable drugs that technology is now enabling people to develop.


Essex: How do you claim the inventiveness to get around this? In biologicals, there is always some risk because you’re isolating something from the natural environment.


Wainwright: It’s going to force people more towards the uses, rather than trying to protect the specific biologic itself. This same thing can be applied to chemistry as well; it takes us out of our normal sphere because mixes of natural products fall foul of these guidelines. It goes far beyond just biologics.


Paranavitane: I suppose when it comes to


drafting claims, does drafting them in a way that adds something significantly different, such as a fluorescent tag, mean that the product is not identical to what is found in living matter?


Wainwright: I like the way the USPTO defines ‘significantly different’. They use significant twice in the definition.


European focus Essex: Turning to Europe, are there many differences between jurisdictions in Europe,


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