Is it possible to patent the sequence (or partial sequence) of human genes?
Genetic research is very important in the fields of diagnosis and treatment of genetic disorders, infectious diseases and non communicable diseases. From the very beginning, genetic research has always been connected with moral and ethical questions, such as the limits to such research.
The field of genetic research also raises interesting questions in the field of intellectual property. One of those questions is whether the sequence or partial sequence of a gene, can constitute a patentable invention.
In the European Union the patenting of biotechnological inventions (including those involving human genes) – is subject to Directive 98/44/EC of July 1998 on the legal protection of biotechnological inventions.
According to this Directive, the human body, at the various stages of its
formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
However, the Directive makes an exception for elements isolated from the human body. Elements isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. Among the member states of the European Union there are different points of view on how broad the scope of protection of such patent should be.