Patenting human DNA sequences in Europe and the US - A comparative analysis of patentability requirements for nucleic acid sequences with special emphasis on novelty and inventive step

Abstract: On 7 March 1953 two young scientists, James Watson and Francis Crick, announced to fellow patrons of the Eagle pub in Cambridge that they had found “the secret of life”. Then, on 25 April 1953, they published an article in the famous Nature magazine and announced: “We wish to suggest a structure for the salt of deoxyribose nucleic acid (D.N.A). This structure has novel features which are of considerable biological interest.” What Watson and Crick suggested in their short article - a model of clarity, precision and British understatement - was the winding double helix structure of DNA which immediately suggested how DNA would replicate itself. Less than 900 words later they concluded on the same page with the simple sentence: “It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.” Their proposed model had great beauty and simplicity, and fitted the experimental data available, so it was soon accepted as correct. While this paper can be regarded as the first step into a new era of genetics, DNA is presently at the centre of a storm. On the one hand, the breathtaking development of DNA related sciences during the last decades led to a technological and medical revolution. Due to the far reaching possibilities connected to this technology, it is the focus of many people’s interest and one source of the hope that one day we will find cures for terrible illnesses. Unsurprisingly, DNA related biotechnological science has at the same time become a very important economic factor in global business. On the other hand, the public has been made much more concerned about the level of knowledge about the human blueprint and how it is applied and commercialized. These debates are highly emotional. This is particularly so with regard to the question of whether it should be possible to patent human DNA. In the often heated debate on the subject there are, by and large, two schools of thoughts. The first is convinced that DNA is simply a chemical compound, albeit a complex one, and takes the view that it must be possible to grant patents on DNA, as on any other chemical compound. The approach taken by the US and European patent authorities basically follows this line of thinking and consequently the grant of (human) DNA related patents has become routine. The second school of thought sees DNA as much more than a pure chemical structure. They argue that DNA is the embodiment and incarnation of the code of life and is part of the common heritage of mankind. They believe that any form of appropriation or patents on DNA is absolutely wrong. Both points of view are bogged down in their own logic and it seems to be extremely difficult to find a compromise. Moreover there is a continuing debate among those who support patents on DNA sequences over the threshold-requirements for receiving such a patent, the appropriate extent of its entitlements and its preclusive effects. Especially the specific issue of patents on partial sequences (ESTs and SNPs) and DNA sequences whose functions and applications have not fully been specified is heavily discussed, since they may have a chilling effect on beneficial research. The purpose of my PhD is to scrutinize this latter debate. I want to investigate different possibilities for patenting (and perhaps even licensing) human DNA technology in the US and Europe. The main goal of my research is to balance the arguments of the parties involved in the debate over specific human DNA related patents, in order to outline a reasonable legal approach that would lead to an acceptable compromise on how to combine economic interests with the necessary freedom of research and an effective product development in the field of healthcare. Naturally this will involve a thorough examination of the scope of protection that is given to various human DNA related inventions by the respective the patent offices. This licentiate thesis represents the first sections of my doctoral project and deals with basic patentability requirements that have a more indirect effect on the scope of genetic patents, namely patentable subject matter novelty and inventive step.