It is a general principle in patent law that a patent claim for a product can only be obtained if said product as such is novel. However, no law without exception. When the European Patent Convention (EPC 1973) was being drafted “interested circles” indicated that it would be valuable to humanity to encourage research involving new therapeutic uses of known substances (BR/135/e/71 ms, point 92). As a result of said lobbying Article 54(5) EPC 1973 appeared [corresponding to current Article 54(5) EPC2000] governing novelty of a known substance or composition for a new medical use. Importantly, medical devices have not been included as a further exception, neither in the original EPC 1973 nor in the process of the drafting of the current EPC 2000, i.e. the legal situation is that no provision exists which renders a known device novel if claimed in connection with a medical use, which use had hitherto been unknown for this device.
Owing to such a shortcoming for the growing medical device industry the idea was born to apply the “substance or composition” provision of Article 54(5) EPC by analogy to medical devices. In this regard it is worth noticing that in particular decision G 5/83 of the EPO’s Enlarged Board of Appeal did not take a literal view of Article 54(5) EPC1973 and considered that although this provision related only to the novelty of substances and compositions for medical use, “it seemed justifiable by analogy” to extend this principle to second and further medical indications. Using the same principle, applicants started to submit that it would seem justifiable by analogy to extend this principle to any medical products next to pharmaceuticals, in particular to devices.
Remarkably, following G 5/83 in 1992 EP 0 257 956 has been granted with a main device claim in a medical use format “A device for…” (a given medical use) and a key point here is that the device was construed by the Examining Division as a true medical use claim, i.e. the medical use has not been ignored but has been given proper consideration as a limiting feature.
However, said liberal approach of the EPO’s Examining Division is out of date and device for medical use claims in the sense of Article 54(5) EPC are no longer accepted, see e.g. recent decisions T 773/10 and T 2369/10 which dealt exactly with this issue.
In both cases the Board considered that there is no basis to contemplate that novelty may be conferred on products, other than substances and compositions, by virtue of the provision of Article 54(5) EPC. In T 2369/10 the Board holds that the ordinary meaning of Article 54(5) EPC shall not be extended so as to include something which is not explicitly provided for, in particular as the Board has failed to find any mention of medical uses of devices in the Travaux Préparatoires of the current EPC 2000, even though Article 54 was subject to a major revision in which G 5/83 has been taken into account. As in the Boards opinion the question regarding the novelty of a device for medical use claim having the form “Medical device Y for the treatment of a disease Z” has been answered directly and unambiguously by reference to the EPC and the Board had no doubt as to the correctness of its answer, the applicant’s request for referral of said question to the Enlarged Board of Appeal was refused. Similarly, in examination proceedings of EP 08 828 222 the Examining Division pointed out with regard to the above mentioned granted “outlier” patent EP 0 257 956 “a single granted application does not suffice to call a point of law into question, that is treated in a highly consistent way without any contradictions on all kinds of levels (EPC, EPO Guidelines, Decisions of the Board of Appeal)”.