New use of a known medical device: patentable in Europe?
In Europe, therapeutic methods cannot be patented. Nonetheless, where a new use of a known pharmaceutical product is discovered, effective protection can be obtained through a special form of use-limited product claim that is provided for by Article 54(5) of the European Patent Convention: “Known drug X, for use in the treatment of disease Y”. In the past, so-called “Swiss” claims were used for the same purpose: “Use of known drug X in the manufacture of a medicament for the treatment of disease Y”.
In its Decision T0773/10, a Board of Appeal of the European Patent Office had to consider whether a similar approach could be used in relation to a new medical use of a known medical device, as opposed to a known drug.
The patent in question, EP1852136, had an independent claim to a dialysis membrane for the treatment of multiple myeloma. The membrane itself was known in the prior art, yet the use of the membrane was novel.
In their argument, the appellant argued that the expression “substance or composition” in Article 54(5) EPC should be construed broadly and extend to any product for specific use in a method referred to in Article 53(c) EPC, and that the membrane of the independent claim, due to its specific nature, should be considered a “substance or composition” within the meaning of Article 54(5) EPC.
The Board, however, came to the conclusion that the scope of the term “substance or composition” in Article 54(5) EPC does not extend to all products for a specific use in a method referred to in Article 53(c) EPC. In particular, when considering the legislative history, the Board found that the term “substance or composition” could not be found to include any product, as it was not possible to prove that the parties to the EPC had intended the term to do so. The legislative history did not include discussions on new uses of medical products other than compounds or “substances”, ie medicaments or drugs.
Furthermore, the Board found that the specific membrane could not be considered to be a “substance or composition” within the meaning of Article 54(5) EPC as the membrane did not contain any further substance or composition which could be considered to constitute an “active ingredient”.
In view of this, the independent claim was found to lack novelty over the prior art.
What this means is that the types of medical invention that may be protected by use-limited product claims is restricted, and it will be difficult to obtain protection for new uses of known medical devices. Of course, if the device is modified in order to make it more useful in the new use, the situation will be very different: the modified device will then be novel and may well be patentable.