PATENTING THE HUMAN GENOME

Biotechnology is a field that is capable of evoking mixed emotions. This is particularly the case when the discussion encompasses the subject of human genome research. On the one hand there are major benefits that can spring from the studying of human genes. On the other hand it has been met with many moral and philosophical disagreements. Accompanying the debate about biotechnology itself has been a debate about whether the products thereof should be patentable. The Human Genome Project, although not yet complete, has provided scientists with vast amounts of DNA sequence information, further highlighting the issue of the patentability of the human genome. As any other field in technology, genetic research need protection for new inventions and has therefore turned to the patent system. Biotechnology is a high-risk industry and investors need a reasonable guarantee to get a proper share of the commercial benefits that are expected to flow from the research. The significance of gene patents lie thus in its ability to attract venture capital to the biotechnology industry. Even internationally there is fierce competition on who is going to attract more investment to the country’s biotechnology industry. The country with the most effective means to ensure sufficient protection is likely to get ahead in the race. But due to the controversial nature of patenting human genes there is also a need to strike a balance between economic and ethical goals. Human genome patenting is giving rise to concerns both at a popular level and within the scientific community. This work focuses on the legal and social concerns that surround the patenting of human genes. The aim is to explain how and why patents have become an important element in the research of the human genome, as well as the implications hereof. I will look at the situation in the US and Europe, with some comments on Japan. I have chosen to concentrate on these legal systems since most of the genetic research is done here. Giving a brief description on each of these patent systems, I will point to the differences and the similarities between them. Moreover, I will recount for the development towards the patenting of genes, explaining what makes a gene a patentable invention. Going trough each of the requirements for patentability, I will account for how DNA can fulfil these requirements. I will also examine problems that may appear and discuss whether the patent system is suitable for protecting human material, taking a look at alternative methods of protection. However, to get a well rounded view I believe it is important to look beyond the most immediate topic and into adjacent areas. Thus I will incorporate an economic and ethical dimension into the legal analysis. Since law is not an isolated phenomenon in society I believe this is necessary to gain a deeper understanding of the forces that shape the law. I will concentrate rather strictly on the patenting of DNA per se and therefore I will not touch upon other related areas, such as process patents and the patenting of other biological materials. Focusing mainly on the requirements and the process to obtain a patent protection, I will leave possible consequences, such as infringement procedures and technology transfer agreements, aside. My approach will be one of a mainly descriptive and comparative method, however with some attempts of basic analysis. The material I’ve used has been gathered mainly from legal and scientific journals. Much of the sources are American since the US is clearly the world leader both in the area of biotechnology research itself and in the inclination to patent its findings. But with the new EU directive on the protection of biotechnological inventions, the activity in the biotech patent realm has gathered momentum also in Europe.