1. The June 2012 issue of epi Information reports a meeting held on 10 November 2011 between the EPO and the biotech committee of the epi. Item 8 that was discussed is reported as follows:
‘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.
2. 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. However investors in biotech like to see that strong patent protection is available in the relevant sector.
3. 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.
4. 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.
5. 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?
6. 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.
7. However based on the comments at the EPO/epi meeting and from the experiences of attorneys I know 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.
8. One argument against being lenient towards claims to personalised treatment is that this is way of evergreening to prolong patent protection for blockbuster drugs.
9. The danger is that with the EPO’s present thinking a test case will have a negative outcome, i.e. taking a strict view on novelty of claims referring to patient groups that overlap with prior art patient groups. In the past trilateral reports have taken strict views on patentability of reach through claims, crystallography inventions and inventions relating to SNPs, and it would be unfortunate for this trend to continue.
10. Should policy considerations determine the way we assess patentability? In the UK this essentially happened in the House Lords decision Conor v Angiotech on inventive step and the Supreme Court decision HGS v Eli Lilly on industrial applicability to bring the UK into line with the EPO.
Update: Decisions T108/09 and T734/12 show the EPO Boards of Appeal are taking a lenient approach to novelty for personalised medicine inventions.