In 1998 the European Parliament and the Council adopted Directive 9844 on the legal protection of biotechnological inventions. The process of implementation of the Directive into national legal systems has encountered difficulties. Their most serious reason was, and are, reservations to the principles of patenting inventions relating to the human body. The aim of this article is to present the three main groups of problems on which the controversy and discussion are focused. The first one concerns problems connected with the concept of invention related to the product - elements isolated form the human body (e.g. sequence of DNA, cells or line of cells) and discrepancies between this concept and the traditional concept of invention. This controversy related mainly to the correctness and justification of this concept on which the Directive is based and to the method of solution of problems which are inherent consequences of this concept of invention. The results of analysis of the Directive's provisions characterizing inventions related to the human body is the basis to evaluate whether it is reasonable to say that the Directive allows to patent the human body. The second group constitutes problems related to the method of interpretation of the ban of patenting inventions where their commercial exploitation would be contrary to public order or morality, which is settled in the Directive. In this part are presented problems and doubts related both to the identification of the object of this ban (commercial exploitation) as well as to the criteria of the evaluation. The third group concerns problems connected with the defining relation, which according to the Directive, should be between allowing the patenting of the invention based on biological material of human origin (or inventions in which that material is used) and informed consent of the donor. In other words, whether the EU states are obliged to guarantee the donor the legal possibility to block the patenting of these kinds of inventions in the event that this kind of biological material was obtained or used without permission. An analysis of the above problems and the method of their regulation in the Directive gives the grounds for conclusion that, because of the specifics of inventions related to biological material of human origin, patents in this area cause many problems. Traditional principles and legal norms including the Directive's provisions do not give explicit solutions which would eliminate doubts and controversy.
Financed by the National Centre for Research and Development under grant No. SP/I/1/77065/10 by the strategic scientific research and experimental development program:
SYNAT - “Interdisciplinary System for Interactive Scientific and Scientific-Technical Information”.