The recent Decision G 2/08 by the Enlarged Board of Appeal has provided guidance on the extent to which a novel use of a known medicinal substance may be protected by a patent, and in particular the patentability of new dosage regimes. At the same time, this Decision has signalled the end of the use of the Swiss form of claim.
Article 54(5) EPC 2000 expressly provides for further patent protection for any "specific" use of a known medicinal substance. The introduction of the word "specific" in this Article caused speculation that the Article would be given a more restricted interpretation as to what may be considered to be a patentable second/further medical use. For example, does it mean that the second/further use must involve treatment of a new disease?
The Enlarged Board found that no such restricted interpretation should be given. The Enlarged Board expressed the view that there is only one sensible way to construe the requirement underlying the specificity of the use, namely by contrast to the generic broad protection conferred by the first claimed medical application of a substance or composition, which is in principle not confined to a particular indication. Thus, the new use within the meaning of Article 54(5) EPC need not be the treatment of another disease. It therefore follows that in Europe a claim to a known medicinal substance, where the only novel feature is a new dosage regime, is in principle allowable.
While previously conflicting Decisions had been issued by Technical Boards of Appeal within the European Patent Office on this question, this Enlarged Board Decision brings the practice of the European Patent Office into conformity with that in many European countries, including the UK.
This case has received a lot of attention because, in addition to the important finding outlined above, the Enlarged Board also took the opportunity to rule that the Swiss form of claim should no longer be used to claim second/further medical uses. The Enlarged Board pronounced that this should have effect for applications with a priority or filing date three months after the date of publication of this Decision in the EPO Official Journal. It has no retroactive effect.
In practice, many practitioners in Europe have already been using a new form of claim language based on Art 54(5) EPC 2000 instead of the Swiss form, as the scope of protection provided by the Swiss form is significantly narrower in scope than can now be obtained. As a precautionary measure, some practitioners have recommended incorporating both types of claim, but this is no longer necessary.
It is good that the Enlarged Board has had an early opportunity to clarify the meaning of the term "specific" in new Art 54(5) EPC. The adoption of a broad interpretation will be a welcome piece of news to poor beleaguered pharmaceutical applicants. As to the Swiss form of claim, as noted by the Enlarged Board, under the EPC 1973 it filled a lacuna. We know what they mean, but good-riddance, nonetheless.