Surgical methods - what's patentable in Europe?

In their decision G1/07, published in February 2010, a European Patent Office Enlarged Board of Appeal (EBA) have clarified what counts as a method of surgery.

The European Patent Convention states that "European patents shall not be granted in respect of: ... methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body".  G1/07 related to a method for MRI imaging in which a radioisotope gas is administered to a patient.  One embodiment encompassed by the claims involved injection of the radioisotope into a patient's heart, although this embodiment was not specifically referred to in the claims.  The EBA were asked to determine whether such a method counted as a method of treatment by surgery.

Previous cases relating to surgical methods had held that a method was excluded from patentability if it was suitable, or at least potentially suitable, for maintaining or restoring the health, the physical integrity or the physical well-being of a human being or animal.  Therefore, a surgical method which inevitably results in the death of an experimental animal is not excluded, but methods such as sterilisation surgery, embryo implantation and cosmetic breast surgery are.

In another earlier case relating to a method for hair removal by optical radiation, it had been held that methods which did not involve treatment of a disease were patentable.  In that case, the hair removal was done for cosmetic reasons and would not result in any cure or treatment of a disease.  Therefore, although the method was considered to be surgical (because it involved destruction of living cells), it was not therapeutic and was therefore allowed.

In G1/07, the EBA went against the hair removal case.  They said that "in order to be patentable a claimed method must neither be a therapeutic nor a surgical nor a diagnostic one".  Thus, in determining whether or not a method is surgical, the purpose of the surgery is irrelevant.

They ruled that a method is excluded from patentability if it involves an "invasive step representing a substantial physical intervention on the body".  This step must be one which requires professional medical expertise, and which entails a health risk even when carried out with the required professional care and expertise.

The EBA also observed that "the scope of what is surgery may change with time."  They made it clear that the patentability of surgical methods has to be decided on a case-by-case basis: a general definition of "“surgery" is not possible.

The claims in G1/07 encompassed both surgical (injection of the radioisotope into the heart) and non-surgical methods.  The EBA confirmed that a disclaimer of the surgical embodiment could potentially be used to avoid exclusion of the whole claim.  However, the disclaimer would have to comply with the other requirements of the European Patent Convention, for instance regarding its basis in the application as filed.

What the Board did make clear is that even if a non-invasive imaging method can be used concurrently with surgery, to provide information to the surgeon, it may still be patentable.

In some respects, this decision does provide an improved definition of what might be excluded from patentability as a method of treatment by surgery.  It clearly points out that the surgical, therapeutic and diagnostic exclusions are to be considered independently of one another.  A further point of interest is that the EBA noted with approval the finding in an earlier case (G1/04) that exclusion from patentability cannot depend on the person carrying out the method.  A claim need not specify the involvement of a doctor or other medical professional in order to fall within the exclusion.

The patentability of surgical methods is clearly an area where issues must be decided on a case-by-case basis according to the facts.  Case law is expected to take some time to develop before the definition of surgery becomes more settled.  It may well be possible to present arguments that, for example, a method does not involve a substantial physical intervention, or that the health risk, if any, is not significant enough for the exclusion to apply.

In the meantime, where an invention encompasses both surgical and non-surgical embodiments, we recommend that the patent application be drafted to include basis for disclaiming the surgical embodiments.

If you have any queries concerning patentability of surgical and other medical methods in Europe, please contact Rhiannon Turner .