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Patents on pharmaceuticals have emerged from an industry engendered mythology as the sacred heart of pharmaceutical innovation; without patents on pharmaceuticals there will be no new medicines, no wonder drugs and no life saving medical devices.

This thesis is concerned with the proper quantum of compensatory damages which should be awarded to the patent holder whose patent has been infringed to recover his losses caused by patent infringement. The balance between the reward to the patent holder and the benefits which society can receive from the patented invention is especially taken into consideration. The contribution of the patented invention will be proposed as a main criterion in the maintenance of this balance, and several formulas which will be used to rank the contribution of a certain invention are the main core of this thesis.

This research establishes a new patent remedy (injunction) system against future infringements in such a way as to discourage trolling behaviours of non-practising entities (NPEs) without chilling inventors’ incentives to innovate. For this research target, this thesis reviewed the general characteristics of NPEs in the current and past patent system, the current patent remedy laws in different countries (the US, UK and Germany), the patent holdups caused by NPEs’ patent enforcement against manufacturers, and various solutions which have been proposed so far. In doing so, it addresses important findings that the major cause of NPE problems stems from the inherent uncertainty nature of patent, that the courts’ discretion of whether to grant or deny an injunction needs to be clearly defined, and that the new injunction system should skilfully balance the short-term as well as the long-term transaction costs which are caused by NPEs’ patent enforcements. Considering these findings, this thesis proposes a new injunction model, alias a ‘three-tiered remedy system.’ Unlike the present two-tiered system, it divides the remedies into three different types: (1) granting an unqualified injunction against wilful infringers; (2) granting a suspended injunction against innocent infringers; and (3) denying injunctions in exceptional circumstances. The most differentiated feature of this model is to award a suspended injunction as a default remedy in order to mitigate the patent holdup arising from the uncertainty problem of patent. Since the suspension period is determined in proportion to the required time for designing around the infringed patent, this new model can provide a very useful solution to mitigate the harmful effect of NPEs’ patent enforcement without jeopardizing the integrity of exclusive right of patent at the same time.

Many patent law dilemmas arise from a failure to understand technologies as embedded in broader social, economic and political realities and to contextually analyze these legal phenomena. This narrowness leads to poor legal development, of which the modern medical exception from patentability is one example. Judges have difficulty interpreting it, patentees do not understand its purpose and it does not protect the important medical technologies to which the public would like access. This thesis applies a legal pluralist analysis to examine the emergence of the medical methods exception in order to understand why it was created and legislated. It starts by examining the origins of the exception in the caselaw, and the informal, concurrent norm established by the emerging medical profession in the early 20th century. It then proceeds to examine why the medical profession might have sought and enforced a norm prohibiting its members from patenting, and concludes that this arose from the need of the medical profession to distance itself from the patent law. As a result, professionalizing physicians established an internal normative order that mimicked and in many cases replaced the effect of the formal law. The thesis then proceeds to examine how the form of the informal norm evolved in the period between WWI and WWII, finding that the profession’s norm transformed and broke down concurrently with its efforts to achieve external legitimacy through legislation. That breakdown arose from factors which included growing labour mobility, greater understanding of the benefits of patents, and a growing role of science and industry in medicine that threatened the profession’s access to valuable medical innovation. The thesis concludes with a study of a current case (Myriad Genetics) that applies the thesis’ theoretical framework to a present dispute over the role the law should play in regulating genetic diagnostic tests.