Pharmaceutical Inventions

Abstract

Abstract This chapter considers the law governing the patentability of pharmaceutical inventions, including new chemical entities, pharmaceutical compositions, and dosage regimes. Provisions in the UK Patents Act 1977 and the European Patent Convention (EPC) exclude from patentability ‘methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body’, although this does not prevent a substance or composition from being patentable for use in any of these methods. Under the EPC, such methods were excluded by being defined as not industrially applicable; the new approach introduced by EPC 2000 is more logical and also clarifies the patentability of further medical uses. Novel compounds that have a pharmaceutical utility are patentable per se in all countries that have implemented the TRIPs Agreement.