مدیریت حقوق مالکیت معنوی در شرکت های بیوتکنولوژی اروپا

The aim of this article is to observe a “real world picture” of how European biotechnology firms manage their inventions, and in particular, how they make use of patent protection. The intention is to compare the behavior and the requirements of the biotechnology industry with the existing legal framework in Europe, to determine industrial needs, and to identify insufficiencies in the institutional settings. The analysis focuses besides the general competitive performance of Europe in comparison to the United States on the use of patents by firms in different European countries, the decision to keep inventions secret or to patent, the different procedural ways to apply for patent protection, as well as the importance of patenting related costs and strategic uses of patenting.

Biotechnology is, besides computer and information technology, a key technology for the economic development of the next millennium. Protection of intellectual property is at the core of the business for biotechnology firms. Nevertheless, the debate on what, how, and when biotechnological inventions can be protected by legal means is still going on. The specific line of investigation of this article is to look at the management practices of patenting in Europe, and to retrieve from the firm perspective opinions on various topics of academic debate. The empirical results derive from a survey carried out with 103 biotechnology firms in several European countries (22 Dutch, 28 German, 20 British, 19 Spanish, 10 Italian, and 4 others). Supplementary information was acquired by telephone interviews with 22 participants from the sample. This empirical work was done to identify the most urgent issues and concerns of practitioners in the field as well as to derive empirical support for theoretical findings. First, the overall performance and comparative world-wide position of the European biotechnology industry with respect to patenting activity is discussed. Later on, specifications regarding to means of applications are presented, along with some aspects of strategic behavior in the sector, and in particular, insufficiencies of the legal framework and the institutional settings in Europe.

European patent applications increased by about 4% between 1991 and 1997. Nevertheless, the absolute number of priority files, which are the important files indicating inventions and their origin, perform poorly in comparison to the United States. The absolute number of priority files in Europe is still about one-tenth of that in the United States, and Japan except for U.K. files, there is no real observable increase in applications over the last decade. If patent applications are a reliable indicator for innovative activity, then these numbers indicate, indeed, that Europe is far behind in biotechnological innovative performance in comparison to the United States and Japan. The enormous future responsibility of many patenting related issues should not be underestimated. The lesson to be drawn from the debate so far is that the intermingling of economic factors and value judgements will make it hard to reach definitive conclusions. A lot depends on how the new directive on legal protection of biotechnological inventions is implemented at the level of the Member States and the subsequent interpretations given it by the courts. The investigation made clear that patents are an important incentive for research and development in Europe's biotechnology industry. However, it also became clear that, in addition to their initial purpose of protection, patents are used in many different ways. The original idea of what patents are and should be, the intention of protecting inventions, and fostering their distribution, is becoming less and less important in comparison to many secondary issues of patents. Administrative tricks procedural difficulties and strategic uses of patents predominate over the idea of protection and distribution of knowledge. This becomes especially clear when looking at strategic patenting, and one has to wonder whether there is already too much patenting. For this reason Heller and Eisenberg [9] warn of what they call “The tragedy of the anticommons” and of the negative consequences of too much patenting, in particular for the biotechnology industry. All these considerations make clear that patents are probably an indicator for a number of things, but less so for direct innovation. For industrial purposes it is hard to understand why the patent law is so overloaded with moral and ethical issues. Business would probably be much easier without this burden, if patent granting were left to technical decision according to the criteria of patentability. So in one way, a more pragmatic approach is desirable for patent law. However, the topics discussed here carry a huge future responsibility, and probably include a number of problematic issues, of which the future consequences cannot yet be foreseen. This is at least one reason why careful treatment is required. Perhaps it is also the particular role of the Europeans to be more sensitive here than the Americans. Therefore, certain “ethical barriers” should be left in the patent law in favor of more plurality and critical awareness.