A comparative study of the patentability standards with respect to pharmaceutical inventions in the United Kingdom and South Africa

Abstract

Using a comparative methodology the thesis analyses the patentability of pharmaceutical and related inventions in the UK and South Africa. The viewpoint adopted is that of the industry actors, who are engaged in the conception through to the commercialisation of inventions, although this perspective is measured against the concerns of wider stakeholders. Drawing, in particular, on the classical justifications of the patent system, the research identifies the attributes of an optimal patentability standard which can be adjusted as technology and the legislative landscape changes. Framing an optimal patentability benchmark as one that both promote and protect the invention, the thesis considers the elements that ground the judicial patentability decision-making process. As pharmaceutical patenting tends to be an emotive and contentious area, the interplay between the international and respective domestic patentability frameworks is also evaluated in its impact on the inventor within the pharmaceutical chain. The research then turns to investigate four individual patentability limbs as applied in the two jurisdictions. The definition of the invention and excluded subject matter is evaluated in mapping out the pharmaceutical activity and the associated research output that falls within patentable subject matter. The novelty, non-obviousness and industrial application limbs to patentability are then examined, giving particular attention to the tests used by the courts in evaluating whether an invention meets the requisite criteria. The argument is made that the courts in interpreting patentability must apply principles advancing the purpose of the patent system in arriving at decisions. A systematic and robust approach is advanced that improves repeatability and precision in arriving at patentability decisions whilst preventing subjective application of the criteria. It is suggested that the application of the tests whilst aligning with the rationale and policy of the patent system, have to make sense to the scientist working in inventive pharmaceutical activities.