Current position of legislative approaches to the grant of patent law on isolated human genes

As medical research is in rapid flux, the scope and variety of inventions in the biotech field is very promising, and gene patents remain important around the world. The international patent law sets the main task to harmonise the basic technical things among the countries. The US Patent and Trademark Office (USPTO) issues thousands of patents for human genes identified by the HGP (Human Genome Project), and it is reasonable to believe that this trend will continue as the HGP isolates and identifies more human genes [1]. This increase is not evident only in the United States, but also in the European Union. But the patentability of genes and sequences of human genes has become the subject of hot debate and considerable controversy, both in the conceptual field and in the legal.
One of the key issues in biotech patenting is the existence of conflicting legal and ethical criteria. The aim of this article is to overview the most important legal and ethical aspects of gene patenting in the core countries, particularly the USA and the European Union. Other countries around the world have different approaches towards gene patenting, adjusting variations of those now applied in Europe or the U.S. to their own national juridical, economic, and political context.
The U.S. patent system is recognised as being the broadest patent protection system, especially in the biotechnology field. U.S. patent law arises from the U.S. Constitution [2]. The product for which the patent is being sought must meet stated levels of novelty, utility, and non-obviousness. The statutory patentability requirements are applied to biotechnology, including DNA sequences, in the same way as they are applied to any other invention [3]. However, there are still many individuals who believe that DNA sequences do not satisfy the basic criteria for patentability: novelty, utility, and non-obviousness. The historical discourse in the U.S. on patenting genes traditionally starts from the case of the Association for Molecular Pathology vs. Myriad Genetics, in which the U.S. Supreme Court held that naturally isolated DNA is not patentable, but that synthetic DNA is patentable [4]. The Court held that isolated human genes cannot be patented because they are not a product of nature and not man-made, and specific gene separation from the rest of the genetic material is not a sufficient condition for the patenting [5]. Professor Watson makes the argument that “human genes should not be...


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