Traditional knowledge protection methods are becoming increasingly out-dated in the face of modern challenges. Focusing on the protection of traditional knowledge and related genetic resources, this book is the first of its kind to amalgamate a novel theoretical framework with the practical applications of the combined theories of Rawls and Coase.

Modern lawmaking in the field of pharmaceutical patents and surrounding regulation is to a considerable extent based on legal transplants. Legal transplantation contributes to international harmonisation without requiring an international convention, something very attractive for actors in the pharmaceutical sector operating on an international market. Despite its informal character, and alleged efficiency and simplicity in the transfer of legal rules from one jurisdiction to the other, it requires certain caution. A legal rule may very rarely be seen in complete isolation from the rest of the legal system, since in some cases it is not possible to foresee the results of the legal rule in the exporting country before the transplant takes place. In the field of pharmaceuticals, significant examples of legal transplants are the Bolar exemption and the Supplementary Protection Certificate, both transplanted to the EU by the same US Act, the Hatch-Waxman Act. This article evaluates these two legal rules, comparing their strengths and weaknesses to those of the original provisions in order to highlight different aspects of the process of legal transplantation and the effect they have on the formation of the transplanted rules.

Supplementary Protection Certificates (SPCs) were introduced in 1992, and have since been considered a very valuable tool for the pharmaceutical industry, allowing for market prolongation and compensating for the effective patent protection time lost in the process of market authorization.

Over the past five years, numerous Court of Justice of the European Union (CJEU) rulings have attempted to interpret the provisions of EU Regulation 1901/2009 and provide clarity to patent holders as well as generics manufacturers as to the protection requirements and the scope of protection awarded. This article analyses the implication of major CJEU cases concerning the interpretation of Articles 3(a), 3(d) and 1(b) of the Regulation.

The article also discusses the interrelation between the EU SPC Regulation, on the one hand, and the Market Authorization Regulation and the Market Authorization Directive, on the other, and compares the EU system with that provided by the USA. An analysis of recent case law reveals that now, some 25 years after the entry into force of the Regulation, the system is still obscure. A serious concern also arises as to whether the system as it stands today is simply inappropriate to the protection of modern pharmaceuticals and whether this is also one of the reasons for the growing volume of case law in the field.