Second Medical Indications and the Swiss-Form Claim: Taming Frankenstein's Monster: Part 1-Solving One Problem Creates Another

摘要

Few patent claim formats present more interpretative difficulties than that of the so-called Swiss form. Taking shape as purpose-bound process claims, i.e. claims directed towards a manufacturing process applied for a particular end, the Swiss form was originally conceived as an attempt to navigate treacherous waters-waters bordered by two seemingly immutable prohibitions on patenting: the excluded, and the old. A jury-rigged solution to a thorny problem, the Swiss-form claim promised to extend patent law's incentives to the discovery of new and useful functions of existing medicaments: repurposing the old to create the new. For inventions known in other fields, inventions with no prior medicinal purpose, a solution had already been given in statute; art. 54(5) of the European Patent Convention (EPC) 1973 allowed discovery of the first medical use of a known compound to be claimed as a purpose-bound product. Once, however, a first medical use for was known: that was it. Secondary indications, arguably no less beneficial than the first, were left out in the cold. The Swiss form was devised to bridge this gap: its purpose undoubtedly noble; its proposed effects glittering. However, this virtuous facade conceals a darker underbelly: an underbelly in which the text of the Convention was mutilated and warped, leaving knotty, perhaps intractable, problems in its wake. This then is the story of the Swiss form: of its birth, its execution and the more recent attempts to disentangle the legacy of its creation. The article is split into three parts, each dealing with specific elements of the issue under consideration. This, the first, deals with the adoption of the Swiss claim within the jurisprudence of the European Patent Office (EPO) and the problems associated with the manner in which the Enlarged Board of Appeal (EBA) of the EPO went about instigating protection for claims to new uses of existing medicaments. It considers the fundamental legitimacy of the format and the hiatus in its interpretation that has only recently been broken. In Part 2 we visit the specific issues raised by the regulation of the market for prescription medication in the UK. We also consider some patent law fundamentals that have a bearing on the issues that are picked up in Part 3, when we finally consider the litigation in Warner Lambert v Actavis in depth. Parts 2 and 3 will be published in the next two issues of E.I.P.R.