The European Patent Organisation (“EPO”) has previously strictly prohibited protecting methods for medical treatment and diagnosis. However, a recent decision by the Enlarged Board of Appeals has clarified and restricted the grounds for rejection under Article 52(4) EPC on the basis of non-patentable subject matter. Thus, many diagnostic methods that were previously unprotectable in Europe may now be patented so long as they comply with the basic guidelines set forth in the opinion.

In G1/04 the Enlarged Board of Appeal stated that, to sustain a rejection for non-patentable subject matter, a claimed method must include steps from all of the following categories: