Personalised Medicines: a Presidential Initiative, inherent treatments, Mayo and Akamai

President Obama recently announced his ‘Precision Medicine Initiative’ in which $215 million dollars would be invested to ‘pioneer a new model of patient-powered research’ in which treatment takes into account a person’s ‘genes, environments, and lifestyles’, the aim being to choose the treatment which is most likely to be effective. Taking his cue from the White House, this Kat thought that now would be a good time to revisit this topic which he previously wrote about in 2012 (see Katpost here). That post complained about the direction the European Patent Office (EPO) was taking in assessing novelty of patient groups, making it more difficult to obtain patents for personalised medicine inventions. I also complained about the US Supreme Court decision Mayo making the situation difficult in the US. Since that post, things have got better in Europe and much worse in the US.

Why does personalised medicine matter? 

The terms ‘precision medicine’ and ‘personalised medicine’ are essentially interchangeable for most situations. The term ‘companion diagnostics’ is sometimes used to describe technology in this area. Personalised medicine is based on the realisation that, since patients form subgroups which respond differently to medical treatments, each patient should be given the treatment most appropriate for the subgroup to which he or she belongs. This approach is presently most advanced for cancer, where therapy is increasingly tailored to the type of cancer the patient has.

The President was good at choosing subgroups

We now know that many drugs only work in a subgroup of patients, and so they have a low efficacy when given to ‘all’ patients. That low efficacy can prevent a drug gaining regulatory approval and heathcare providers will also be reluctant to buy drugs which are ineffective in many patients. The development of companion diagnostics can solve these problems by allowing prediction of the subgroup in which the drug will work.

Problems in patenting personalised medicines

In Europe personalised medicine inventions will need to ‘fit into’ medical use claims. If, for example, we know that the subgroup in which the drug works has a particular genetic marker Z, then the claim can take the form below, which tends not to raise too many eyebrows at the EPO:

‘Drug X for use in a method of treating condition Y in an individual, wherein the individual has genetic maker Z’

However if patentability lies in a ‘new’ method of detecting a genetic marker that is already known in that disease context, then things get more complicated. Claims along the following lines need to be attempted:

‘Drug X for use in a method of treating condition Y in an individual identified as having genetic marker Z using [new method of detecting Z]’ 

‘Drug X for use in a method of treating condition Y, wherein said method comprises testing an individual using [new method of detecting Z] to determine whether the individual has genetic marker Z, and providing treatment if the individual is identified as having genetic marker Z’

The EPO Examiner was not convinced that
multistep medical use claims were allowable

Such claims are stretching the ‘medical use’ format a little, and whether they are allowed can depend on the factual scenario and the generosity of the Examiner.

Leniency at the EPO – is this due to the particular approach to ‘inherency’?

Decision T734/12 of May 2103 seems to represent the EPO’s present position on the matter. In this case the Board overturned the Opposition Division’s previous finding of lack novelty based on the Division’s approach there should not be an ‘overlap’ of the patient population defined in the claim with the population defined in the prior art. It now seems that an ‘overlap’ does not prevent a subgroup being novel, and clearly such a lenient approach is helpful in protecting personalised medicine inventions.

Some commentators have described this way of looking at the novelty of a patient population as ‘selection invention’ test. However this Kat disagrees, and believes that it comes about as a result of the EPO’s approach to inherency in medical treatment situations. Essentially, in most situations, the EPO will not view a medical treatment which occurs inherently in the prior art as being publicly disclosed unless the prior art explicitly mentions it. Those familiar with US practice will know that the opposite is true there: all inherent ‘medical treatments’ are assumed to be disclosed in prior art that describes administration of a drug to a patient. The EPO’s view means that the ‘inherent’ treatment of a subgroup is not disclosed by prior art describing giving the drug to ‘all’ patients. Though it is not relevant to the present situation readers may be interested in this ‘K’s Law’ post on inherency at the EPO.

The disastrous situation in the US

We still do not know what the full impact of the Mayo decision will be in the US, but it is clear that this decision is potentially very far-reaching and is presently causing difficulties in examination of inventions relating to diagnostics. The diagnostics and personalised medicines industry is having to cope with the tremendous uncertainty of not knowing what is patentable in their area. The recent Interim Guidance on defining eligible patent matter (see Katpost here) provides little information about how the United States Patent and Trademark Office (USPTO) will assess eligibility of a claim to a diagnostic based on a natural correlation. This Kat notes how in the Mayo decision the Supreme Court took a very strict position, not wanting the development of future ways of measuring the metabolite to be inhibited by a patent claim. If that principle does become relevant to assessing the eligibility of diagnostics inventions, clearly the scope of protection that can be obtained will be severely curtailed. A patent could then only cover use of the known specific techniques to measure a correlation. In fast-moving fields where new assay techniques are being continuously developed the real term of effective protection could then be quite short.


The Mayo decision had caused mayhem

In June 2014 the US Supreme Court decision in Akamai found that direct infringement by a single party had to occur before ‘inducement’ of infringement could be found (see Katpost here). This reversed the previous finding of the Federal Circuit that inducement of infringement could be found where different parties had performed different steps, but taken together all the claimed steps had been carried out. In the case of personalised medicines the diagnostic and treatment steps will often be performed by different parties, and so this makes it harder to find infringement of claims in which diagnosis and treatment are defined as two separate distinct steps.

The ethics of personalised medicines

Soon after the President’s initiative was announced ‘The New Yorker’ posted this article about a case where a young girl was misdiagnosed by a genetic test as having the very serious condition DiGeorge syndrome. It raises the issue of whether doctors, patients and relatives are ready for the information that genetic testing will bring. This Kat wonders about the implications of having ‘treatable’ and ‘non-treatable’ patient groups defined by their genetics, and making decisions on whether to treat people based on tests which are not yet 100% accurate. Readers interested in knowing more may want to see this article on the ethical, legal and regulatory issues around personalised medicines.