Developments in the patentability of human genetic material

Historical background

Little had been known about human genetics before the beginning of 1970s when the science arose to develop rashly. Nowadays numerous landmark decisions mark the history of legal developments including the “Rote Taube” (red dove) decision of the German Supreme Court. From today’s perspective, human genetics is an overlap of “major” areas of biotechnology, i.e. plant, animal and human biotechnology, as well as of patents in the field of chemistry.

The earliest legal problems in the area of “genetics” which are still being discussed today can be found already in the decisions based on the Patent Act of 1877. This is also due to the fact that many are keen to derive plant genetics from the principle for cross breeding of two garden peas which differed with respect to the form of the seed and the colour of the seed. This principle was discovered by an Austrian monk Gregor Mendel in the middle of the 19th century.

Furthermore, the above-described issues were accompanied by the matter of the internationalisation of patent law, which was occurring Europe- and world-wide irrespective of the particular level of scientific development and opportunities for economic application as well as of the legal developments on the national level.

Initially, “genetic” inventions occurring at the turn of the century, were generally concerned with microbiological plant breeding, which was systematically attributed to the area of privileges. Nonetheless, the Patent Act of 25th May 1877, which entered into force on 1st July 1877, thus closing the debate on privileges dating back to the Middle Ages, established the general principles underlying today’s regulations in the framework of substantial, procedural and organisational law. Furthermore, first and at the same time rudimental rulings in the area of genetics and inventions referring to human beings were based on this Act.

Harvard mouse, transgenic mouse

The US-patent 4,736,866 of 12th April 1988 was concerned with

“A transgenic non-human eukaryotic mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.”

This and comparable “results of scientific studies” – beyond any considerations of ethical, religious or legal nature – are supposed to justify the “never-ending opportunities” which they aim at achieving, i.e. curing severe human diseases and supporting human life.

The patentability of human genotype

Human genotype, i.e. – more precisely – 3% of genes, serves the purpose of protein production and thus “lends itself to industrial application”. A “gene” as such, no matter if of plant, animal or human origin, can be considered “an invention”, although it has already existed. A gene as such is a natural material and thus does not constitute a mere “discovery” (which is not patentable), because the innovative step would consist here in the “applicability”. Furthermore, a gene serves more purposes than a mere representation of information (which is not patentable).

Thus, genes which are responsible for the production of proteins can be considered “new”, as long as the respective protein has not been known before.

Therefore, human genes could be generally patented, but there is still the question if the patentability of human genes involves violation of moral principles: luckily enough, numerous possibilities of application fail because they do not comply with legal regulations such as the Genetic Engineering Act or the Embryo Protection Act. However, if the possibility for application does not fail, usage in compliance with law is almost completely excluded due to violation of moral principles.

The last way to generally ban patentability would be by means of ethical considerations or by changes in law (especially of the Directive on the Patenting of Biotechnological Inventions). From the ethical point of view, the monopolisation of human genes is objectionable. As a result of patenting human genes, human genetic material or the produce thereof would “belong” to the owner of the patent. He would be the only person allowed to use “his invention”, i.e. “a human gene” (compulsory licences could provide a remedy, they have, however, proven to be a “blunt sword” and no solution to the ethical issues). Although in the USA “anything under the sun” is considered patentable since the Charkerbry case, Europeans agree (in spite of possible competitive disadvantages for biotechnology enterprises) that human beings cannot be bred. Therefore, unlike in the USA, human genetic patents should be banned.