Personalised medicine (or precision medicine) is the tailoring of therapies based on the genetic, metabolic, behavioural or environmental backgrounds of patient sub-groups. It is a move away from the traditional, one-size-fits-all approach of giving the same treatment to all patients having the same condition.
It is an inconvenient fact that some drugs work well in some patient sub-groups and not in others. If a sub-group of patients for whom a drug is effective can be identified by a characteristic biomarker, then the drug can be administered selectively to that sub-group, therefore avoiding wasteful, ineffective treatment of other patients. This is the aim of precision medicine; to provide only the right patients with the right treatments (at the right time).
Inventions in this field usually lie in the identification of patient sub-groups and their characteristic biomarkers (e.g. characteristic gene mutations). This raises some interesting questions in terms of patentability. For instance, if it is already known that compound X can be used to treat disease Y (broadly, in all patients), how patentable is the finding that the same compound is particularly effective in the treatment of the same disease in a particular patient sub-group of patients defined by the presence of biomarker Z?
The European Patent Office takes a relatively pro-patentee approach. In the scenario above, although there are potential novelty and inventive step hurdles to overcome, it is entirely possible to obtain a granted claim reading: "Compound X for use in the treatment of disease Y in an individual having biomarker Z”.
There are additional difficulties for applicants pursuing US patents, however. As reported here, the decisions in Mayo (the 2012 case referred to in the article below), and subsequent cases, have resulted in fundamental objections being raised against US patent applications directed to many biotech inventions, particularly diagnostic methods. In short, the US Patent and Trademark Office (USPTO) now considers many diagnostic methods to be based on “laws of nature”, which are considered to be patentable ineligible subject-matter.
Precision medicine typically involves determining whether or not an individual is in a particular patient sub-group by the determination of the presence, absence or level of a characteristic biomarker. Such determinations are usually unavoidably diagnostic in nature. It is therefore not surprising that since the Mayo decision it has become more difficult to obtain granted US patents in the area of precision medicine.
As patent attorneys handling many patent applications in this field, we have observed the USPTO's change in approach first hand. The article below puts some numbers on the startling extent of the change in recent years.
It is more important than ever for European universities and biotech companies to bear US practice in mind when drafting patent applications.
The data, presented on 11 August at the Intellectual Property Scholars Conference in Stanford, California, address patent applications in eight categories that commonly include personalized-medicine patents. They show that following a key Supreme Court decision in 2012, the US Patent and Trademark Office (USPTO) was nearly four times more likely to deem subjects of such applications unpatentable — and applicants were less than half as likely to overcome those rejections.