Recent European Legal Developments on Second Medical Uses and Dosage Regimes

Abstract

1Mylan, Albany Gate, Darkes Lane, Potters Bar, Herts, EN6 1AG, UK 2Innovate Legal, 107 Fleet Street, London EC4A 2AB, UK. *Author for correspondence: E-mail: fiona.bor@mylan.co.uk A short history of patenting second & further medical uses in Europe Patent applications made to the EPO are prosecuted according to the rules laid down in the European Patent Convention (EPC), the first iteration of which was the EPC 1973. This contains a provision, Article 52(4), which states that methods for the treatment of the human body by therapy are not to be regarded as inventions that are susceptible to industrial application. The original rationale behind this provision was to exempt the activities of physicians from patent infringement. Initially, ‘use’ claims purporting to protect a novel and inventive second or further medical use of an existing drug molecule were thought not to be available under the EPC 1973 because they were said to claim methods of treatment that were ‘deemed’ unsusceptible to industrial application under Article 52(4) and, therefore, unpatentable under the EPC 1973. However, in its landmark ruling in the Eisai/Second medical indication [1] case, the Enlarged Board of Appeal of the EPO ruled that the EPC 1973 did not exclude second and further medical indications of existing products from patent protection. The Enlarged Board decided that a claim for a second medical use would be valid if phrased in the form set out in a statement of practice issued by the Swiss Federal IPO, namely, “the use of compound X in the manufacture of a medicament for the treatment of disease Y ” [2]. This type of claim became known in the jargon of patent attorneys as a ‘Swiss’-type claim. For the purpose of grant, the EPO considered claim wording in Swiss form not to give rise to a contravention of Article 52(4), based on the somewhat artificial premise that the claim was for the ‘manufacture’ of a substance and not to a method of treatment. Following the decision in Eisai, not only were novel and inventive second and further medical uses of existing molecules deemed patentable but, in addition, it was subsequently held that patentable inventions could also include a new formulation or dosage regime of an existing drug product.