The fact that legislation differs per country can stand in the way of effectively protecting inventions in the field of personalised medicine. Inventors should be aware of this in advance.
The success of patient specific treatments based on an individual's DNA, their treatment history and lifestyle is creating a strong growth market for personalised medicine. In particular in relation to cancer, inventors are making promising progress with this type of treatment.
Sub-type of illness
In personalised medicine it is all about getting the right drug, in the right dosage, at the right time. Inventions may include methods used to diagnose a specific sub-type of a disease, a drug to treat a specific patient group or even specific dosages for such a patient group.
Plenty of challenges
The protection of inventions of this kind does, however, present inventors and their patent attorneys with plenty of challenges, if only because patent legislation differs per country or per region. The European Patent Office (EPO), for example, often requires a selection to be made from the patient group as a whole to make the invention distinct from existing inventions. The addition of this selection step makes the 'old' invention - the existing drug - novel.
Things are different in the US, where natural correlations, such as those that exist between patient group and optimal treatment, cannot by definition be patented. In that case, the art is to restrict an invention in the field of personalised medicine in such a way with additional elements from the patent application that it is not just a matter of natural correlation. It is possible to do so, for example, by adding a specific detection method to the invention.
A patent application filed for whatever country or region should furthermore take account of the fact that there are generally several parties involved in a treatment in the field of personalised medicine, such as a pharmaceutical company and a diagnostics lab. In the case of an infringement it is then no longer possible to point the finger at a single infringer, because the pharmaceutical company sells the drug, while the lab takes care of the patient selection step.
Although it is not easy to file a patent application for personalised medicine, it is definitely not impossible. You will need to adopt a smart and carefully thought-out approach.
In the article Personalized medicine: a booming market and a struggling patent system patent attorney Mark Jolink explains the exact pitfalls in protecting personalized medicine.