KEY ISSUES IN LIFE SCIENCES IP


Myriad/Mayo


Martin Essex: Having been at the BIO international convention in San Diego in June, I know that the dominant subject in life sciences IP at the moment is the patent eligibility of natural products in the US following the Myriad and Mayo court cases.


The first ruling was on whether a naturally occurring segment of DNA can be patentable, to which the answer was no. The second was that claims covering medical tests to help decide what dosage of the drug to give are also not patent-eligible. Then the US Patent and Trademark Office (USPTO) issued its guidelines, which seemed to go much further than that—some have said too far.


So I’ll begin by asking you the way you see things going, and if you think what’s happening in the US has lessons elsewhere.


Jane Wainwright: I’m sure everybody has read the guidelines—there are so many things wrong with them. I, personally, don’t disagree that natural products should be excluded. If they’re found in nature then I don’t think they should be patentable. But I think the guidance has gone far too far, and there are things in there, specific examples in the guidelines, which exclude things that should be patent-eligible.


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They should be considering whether the subject matter is inventive or not and I think they have overstepped the mark. Certainly, a large number of comments have been sent in by various bodies, including our own Chartered Institute of Patent Attorneys, and it’ll be very interesting to see how the USPTO responds.


The other thing for me that really stood out is that they have written it in a very US patent office style: if they could say it one sentence, they have said it in ten pages. It’s just incredible how that’s true throughout the USPTO—this document in particular sums that up. Why can’t they make things clearer for applicants?


Essex: I went through those responses and every single one I looked at was negative: from


the companies, the lawyers and the individual organisations that responded. Absolutely everybody said the USPTO had overstepped the mark.


Paul Chapman: The difficulty is going to be that with that wave of anger against it, can the USPTO be big enough to admit that it has made a mistake? It is unprecedented to have this level of objection and I don’t know whether it will be able to. It has made it clear that it is not going to withdraw the guidelines, although they might be amended.


Essex: If the courts have decided in two particular cases that this is what should happen, is the USPTO allowed to say: ‘we think this is what you should do’. Does there not have to be legislation?


Wainwright: That is one of the biggest problems. Neither Congress nor the courts have made these rulings and it seems to me that a lot of what has been submitted in the responses has highlighted that. The guidance doesn’t follow what Congress or the courts have said and it has taken it too far. Something of this magnitude, as fundamental as patent eligibility, should be decided by Congress or the courts. It has massively overstepped its remit but it doesn’t, at the moment, acknowledge that. It just says this is a logical extension of the Myriad decision.


Life Sciences Intellectual Property Review Roundtable 3


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