Taking it personally: patents, medicines and genetic markers

Purr-sonalised medicine

The IPKat is all in favour of medicine which, he thinks, can come in really handy -- even when you're unwell.  He was therefore fascinated to learn of a recent discussion in Europe of a topic which has already exercised some of the finest minds of his American colleagues: the patenting of inventions relating to personalised medicine.  Having heard about this from katfriend Suleman Ali (Holly IP), he is pleased to say that the latter was willingly persuaded to write a short note on the topic for the benefit of readers of this weblog. Here it is:

"Is the EPO changing Its stance on personalised medicine inventions?

Case law is an important means by which we know what is patentable at the European Patent Office (EPO). However, sometimes the EPO’s view of what is patentable in an area changes before the case law does. This can sometimes be detected when Examiners start raising objections they would not have previously done. Clearly, applicants need to know about such changes as soon as possible so that they can revise their filing strategies and re-evaluate their expectations of the claims they are likely obtain. Meetings between the EPO and the epi (the professional institute for EPO attorneys) are very useful forums for obtaining ‘inside information’ about the EPO’s thinking which is not yet apparent from the case law. The June 2012 issue of epi Information provides a report of such a meeting held on 10 November 2011 between the EPO and the biotech committee of the epi. Discussion item 8 is reported as follows:

‘8. Inventions in the area of pharmacogenomics 

This concerns cases which are based on a genetic marker to treat a disease, for example methylation profiles. It can involve a new patient group defined by an SNP. The EPO said that often the claims can lack novelty, as one patient will have inevitably been treated with the SNP, even if the art does not explicitly say so.’

The EPO’s comments seem to indicate that it is about to change the way it assesses novelty when looking at medical use claims that refer to treatment of a specific patient group.

To give a little technical background to the EPO’s comments, an SNP is a form of genetic marker which varies between individuals. The idea behind the relatively new field of pharmacogenomics is that, if you know which SNP variants a patient possesses, you can personalise the drugs given to a patient in accordance with his genetic makeup. It is now recognised that the genetic makeup of an individual can be very influential as to whether he responds to a drug, and so one application of pharmacogenomics is to only give those drugs to patients who will respond to them.

Personalised medicines can also be based on non-genetic biomarkers, such as the level of virus the individual has.

Personalised medicines offer the potential to use drugs much more effectively. That is clearly of benefit to patients, but should also help to reduce costs in times when many governments feel increasingly dismayed at the yearly increases needed to health budgets. The sector most likely to benefit in the short time is cancer therapy where most of the work in identifying biomarkers is focussed. However, biomarkers are increasingly being sought for many other diseases.

Presently, suitable biomarkers for personalised medicine are proving difficult to find. So it seems that the sector is going to require a lot of investment -- but in investors in biotech do like to see that strong patent protection is available in the relevant sector.

Personalised medicines, and in fact diagnostics in general, has been thrown into uncertainty in the US after the Supreme Court’s decision in Mayo v Prometheus [on which see earlier Katposts here and here] which found that a claim referring to steps that determined the level of a drug in a patient was directed to a law of nature and was thus not patentable. It would be unfortunate for personalised medicines to be dealt a further blow by the EPO, making the test for novelty stricter in this area.

Claims for personalised medicine inventions can have many different forms, but typically they are along the following lines:

Substance X for use in a method of treating condition Y in an individual with biomarker Z’.

There is an argument here that perhaps applicants only deserve claims to the method of selecting the individual (by detection of the biomarker), and not to treatment of the individual. However there is a lot more money in therapy, with figures being quoted of 6% versus 94% for the money to be made in selection versus therapy. Since personalised medicine results in therapy being more effective, there is an argument that the applicant deserves claims to the therapy step.
The crux of the present issue is whether limiting a medical use claim by specifying that the individual has biomarker Z will confer novelty where the prior art is silent about patients having biomarker Z, but where patients with biomarker Z will inevitably have been treated, i.e. does limiting a medical use claim to a patient group that overlaps with, or is within, the prior art patient group, make the claim novel?

The earliest case to tackle the issue seems to have been T233/96 which gave a strict two-part test for novelty requiring the patient groups to be non-overlapping and for there to be a functional relationship between the biomarker and the therapy, i.e. the patient group could not be an arbitrary group. However, subsequent case law has not followed the test. In T1399/04 the Board cited T233/96, but took a different view, generously allowing claims which covered more than 50% of a prior art patient group. Decisions T836/01 and T1642/06 also allowed claims where patient groups overlapped with the prior art.

Based on the comments at the EPO/epi meeting and from the experiences of attorneys I know who are handling European patent applications in this area, it seems that EPO is taking a stricter view of the issue, and is probably looking for a test case to change the case law. If the EPO decides on a test which is based on the concept of a patient with the relevant biomarker ‘inevitably’ having been treated, presumably this is a prior use test, in which case it would be burdensome for applicants to locate evidence on what actually happened. However if the test is similar to that used in T233/96, i.e. requiring that patient groups do not overlap, then it will have the effect of severely curtailing patent protection for personalised medicines because most drugs are initially given to everyone with the condition.

I hope that the EPO will be wise enough to recognise that making the test for novelty stricter for medical use claims limited by patient group will have a substantial impact on the patent protection that can be obtained in the area of personalised medicines, at a time when this very promising sector needs all the support it can get".

Thanks, Suleman, for this most instructive piece, says the IPKat.  Merpel is fascinated by this for quite another reason, though.  It reflects a growing trend towards what might be termed "mass personalisation".  We have it in branding and marketing, where the use of sophisticated software in reading your emails and online purchases enables a personalised dose of advertising to be specifically targeted at the individual. It also exists in the design and fashion sector, where a combination of interactive software and manufacturing improvements produces the result that a purchaser of, say, sports shoes, can determine the style, size, colour and bolt-on features that characterise it, rather than going into some random shop and putting a tentative foot into a sample shoe that might previously have been tried by someone with sweaty socks and fungal growths between the toes ...

Your own personalised medicine here and here [not for the squeamish]