Q: When is medical use no use? A: When it's in a patent claim
The IPKat's friend, patent attorney Kevin Cordina, takes this opportunity to raise a patentability issue that troubles him, involving an inconsistency between the way the law treats use-of-medical-product patent claims. Kevin writes: The IPKat would also like some answers to the questions in the final paragraph and hopes that readers can help (please post your comments below if possible). Merpel says, regardless of what the law actually means, it would be great if some serious debate were to be kick-started as to the policy issues which underlie the law: do they serve the public interest and, if not, how might they be better able to do so?"Article 53(c) of the European Patent Convention (EPC), and its equivalent in many national patent systems, excludes from patentability any method of medical treatment by surgery or therapy practised on the human or animal body. Any claim which is characterised as a method of medical treatment is thereby automatically prevented from consideration for the grant of a patent, regardless of its inventive merit. Article 53(c) adds: "this provision shall not apply to products, in particular substances or compositions, for use in any of these methods", thus allowing protection to be obtained (subject to the usual criteria of patentability) for medical products, including substances and compositions.
It is generally accepted that a new non-medical use of a known product can be protected by a claim in the form "Use X of known product Y", but such a claim formulation is not possible for medical uses. Articles 54(4) and (5) EPC provide compensation to the inventor of a new medical use of a known substance or composition. They allow a composition or substance itself to be patented for a new use even though that composition or substance is already known for use in a non-medical field, or for a different medical use. Such claims may be in the form 'X for medical treatment' (first medical use) or 'X for the treatment of Y' (second medical use). In non-medical fields claims of this form would lack novelty over prior disclosure of X for a different purpose because 'for' is read as 'suitable for'.Articles 54(4) and (5), in contrast with Article 53(c), are restricted to 'compositions and substances'. Accordingly medical use claims cannot be used for new medical uses of known apparatuses. This potentially leaves a whole class of invention without the ability to be protected, simply on the basis that the invention is implemented using an apparatus rather than a composition.
Given that the drafters of the EPC included the term 'product' in Article 53(c), and provided substances and compositions as examples, it seems surprising that Articles 54(4) and (5) are restricted to only substances and compositions. Section 4A(2) of the UK Patents Act 1977 uses a different form of words and does not make any reference to products, but solely refers to substances and compositions. Yet another form exists in the previous Section 4(3) of the UK Patents Act which reads "... a product consisting of a substance or composition ...". In effect this is probably equivalent to the new wording, but it is interesting to see the potentially broader word 'product' slip out.
Are inventions that are based on substances and those based on apparatuses deliberately treated differently? Or is it simply the case that, when these sections were drafted, medical devices had not matured sufficiently for new medical uses of known devices to have been considered? Given the rapid advances in the use of devices for the treatment of new conditions, this category of invention seems likely to assume greater significance. The inability to secure patent protection could inflict injustice to inventors in respect of inventions that have no less potential to 'do good' than a new use of a known substance which could be protected".
