Protecting inventions and promoting innovation - a difficult act of balance. A study of the experimental use exception and the research tool issue

Abstract: The increased patenting activity worldwide, especially in the biotechnology field, has lead to an increased fear of blocking effects for the technological progress and follow-on research. Many inventions have an important application as research tools, meaning that they are used in facilitating research. Genetic sequences are for instance crucial in drug discoveries. Difficulties in gaining access to important research tools, due to for instance high license fees and patent thickets, may delay or thwart scientific and technological development. In this respect, the experimental use exception, provided by most patent laws, has come into focus. In order to balance the exclusive rights provided by a patent, the exception provides a right for third persons to conduct research upon a patented invention in order to encourage follow-on innovation. The nature, scope and application of such research exceptions differ between the different members of the international community. Neither within the EU is the exception fully harmonised, even though most European countries exempt experimental uses relating to the subject-matter of the patented invention. Research in order to improve, invent around or develop knowledge of an invention is permitted, while experimenting with inventions, i.e. as research tools, is not exempted. Belgium clearly deviates from this approach, exempting all uses of patented inventions. The limited and inconsistent case law regarding the experimental use exception has mainly concerned clinical trials. The relatively newly introduced regulatory approval (Bolar) exception has harmonised the EC approach regarding clinical trials for generic products within the EU. There is however divergent implementation and opinions on whether the exception applies to new drugs and research tools necessary in conducting clinical trials. Compared to Europe, the US has a very narrow experimental use exception, only exempting uses with non-commercial purposes. The statutory Bolar exception has instead been held to cover a wide range of patented inventions and activities, and to research performed both in the early and late R&&semicD stages. This broad scope has been considered as potentially depriving research tool patents of their value. Exempting all uses of patented inventions under the experimental use exception has been proposed as a solution to the problem of obtaining access to research tools in basic research. However, this may cause concerns as regards the underlying purpose with the patent system, which is to provide incentives to invent and promote scientific and technological innovation. If research tool inventors are not able to recoup their R&&semicD costs the incentive to invent new and improved tools would diminish. There is thus a need to balance the patent holders interest of protecting their inventions and the public interest of stimulating scientific and technological development. Alternative and conceivably more balanced solutions to broad experimental use or regulatory approval exceptions have been suggested, such as exempting academic research, compulsory licensing, reach-through royalties or introducing a fair experimentation exception.