The Protection of Second Therapeutical Use Inventions in the Practice of the European Patent Office

Abstract

The paper addresses the issue of patenting inventions for new therapeutic uses in the light of the legal framework provided by the European Patent Convention and the case law of the EPO Technical Boards of Appeal. The patenting of new uses of a known compound is, especially in the pharmaceutical field, an essential lever to promote innovation. In recent years, the EPO has adopted an increasingly "accommodating" attitude towards this type of findings, clarifying that the new therapeutic application is not to be confined to the treat-ment of a new ailment, different from the one cured by the previous use of the compound, but may well target the very same technical problem (i.e. the cure of the same disease). Thus, protection (in the form of new therapeutic use inventions) has been granted to find-ings aimed at modifying the form of administration of the drug or its dosage, at changing the functioning of the drug at a physiological or cellular level, or even validating the use of the therapeutic treatment for a new class of patients with different characteristics. Given this new expansionist drift of protection, however, many knots remain to be unravelled. In particular, a clarification would be needed with regard to the perimeter of exclusivity at-tributed to inventions of new therapeutic use, which should be considered as product in-ventions limited to the specific field of use, but whose structure is generally identical to that of other inventions that insist on the same molecular composition.

Keywords: patent, first therapeutical use, second therapeutical use, purpose-bound product protection

JEL Classification: K11, K20