Key European Patent Office decision on medical treatment patents

As a matter of public policy, the national governments in Europe have decided that vets and doctors should be allowed to treat their patients without protecting one method of surgery or therapy over another.  This is one of the few areas where there are special exclusions from the normal patent system.

Inevitably, the law has developed to fill in some of the details concerning this exclusion and the extent to which it does - or doesn't - apply to individual inventions.  Now, a decision issued by the Enlarged Board of Appeal at the European Patent Office has taken the law in this are one step further.

The facts

In simple terms, the invention at the centre of this decision involved injecting a substance (polarized 129 Xenon) directly into a patient, e.g. directly into their heart, and then collecting an image that would help a surgeon as a form of examination of the patient.

The issues

Previously, the caselaw has established that examination of a patient is not, in itself, a method of treatment by therapy or surgery.  Hence, it is still possible to get patents for new devices and new methods that help give a better examination of the patient.  However, in this case, the evidence suggested that the injection is a tricky thing to do and should only be done by a trained and highly skilled surgeon - and even then the injection carries significant risks.  So, in this invention, the injection came closer to being a kind of surgery in itself.

The decision

The Enlarged Board of Appeal decided that this medical imaging technique should not get a patent - because it involves significant and risky surgery and ends up as a “method of treating a human or animal body by surgery”.

An injection of polarized 129Xe into the heart represents a substantial physical intervention on the body which entails a health risk and requires professional medical expertise to be carried out.  Such an injection should be regarded as a method for treatment of the human or animal body by surgery, even though, in the context of the claimed imaging methods, the physical intervention on the body does not aim in itself at maintaining life and health but constitutes a prerequisite for the collection of data in the course of an examination phase of a medical diagnosis.

This area of the law can affect many different technologies, from mechanical surgical instruments to electronic medical imaging devices to chemical or pharmaceutical products.  Appleyard Lees are experts in this area - give us a call.