LEGAL ASPEC`TS ON PROPERTY RIGHTS AND THE PATENTING OF BIOTECHNICAL INVENTIONS

In recent years the achievements within the field of biotechnology have been immense. In this paper I will take a closer look at how and to which degree patent law has managed to adjust and keep up with the advancements in this relatively new composite scientific field. The intention is to try and extract what the central prerequisites for patentability are. The achievements within synthetic genomics will also briefly be touched upon. The main objective is to look at the current legal framework regarding patents and the situation within Sweden. The study is not meant to be comparative and foreign circumstances will only be touched upon when needed for analysis. Patent law does not exist in a vacuum and therefore the relevant legislation, guidelines and practice of the European Community, especially the Directive 98/44/EC Biotechnology Directive of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, as well as of the European Patent convention and the European Patent Office will be thoroughly analyzed. Since biotechnology is a rather distinct field that in many respects differs greatly from other technological and scientific fields, how we define the concepts, like biological material, discovery, invention, and technical applicability therefore become central for how we regard inventions that include biological material. Often the concepts introduced in the law could be regarded as rather hollow which means that we must apply ourselves to analyze these and fill them with substance. Patent law is a very complex area that affects many other legal frameworks, like commercial and contract law. It is almost impossible to analyze patent law without touching on questions of competition law since exclusive property rights as such have implications on free trade. On the other hand patent and competition law are generally regarded to complement each other when it comes to the development and the dissemination of technology. This has to do with the nature of exclusive right. Used in the proper way it will not only serve as a valuable means for market penetration and commercialization but also set the standard for other creative people to come up with inventions that either can use this technology or make it redundant. In order to get a comprehensive look at the subject matter and gain a better understanding of patent law and biotechnical inventions I have, however, decided to only look at the legal framework for the granting of exclusive rights. Bioethics will not be dealt with at all. First there will be a brief introduction to the subject. Then I will conduct a thorough analysis of the Patent Act (1967:837) and thoroughly examine the concepts of the law and try to establish whether there is a unanimous view on how the legal provisions should be interpreted and applied. In the final part of the thesis I will use my findings as a stance to take a closer look at the problems and opportunities that biotechnology, and especially gene technology, introduces to patent law. Product and gene patents pose a specific problem in that their broad claims, if granted, are excluding certain biological material from the public domain. However, they do not always have to be bad. If the technical feat achieved by an inventor calls for it, extensive exclusive rights are often a guarantee that the proper financial rewards are extended. The concept of invention and the prerequisites of the Patent Act all serve to set a high standard for what can be considered to be patentable and there is a system in place for examining an invention from all angles before a patent is either rejected or granted. To conclude the thesis, I will analyze the concept of inventive step and conduct a discussion around important, some ground breaking, inventions in the biotechnological field. Some of these have been granted a paten and some not. If a patent is granted, the holder of said patent will also come to enjoy equivalency protection. If a patent cannot be granted we have to find other ways to move forward and find some kind of property protection so that the invention can be commercialized.