Patents and Life

I write my column Patents and Life in TCS Daily on 6 May 2004.

If patents in this area are not allowed, or left ambiguous, much of the research will have difficulties reaching a commercial potential, and will leave Europe lagging behind in the pharmaceutics and biotechnology fields.

On May 1 new legislation on genetic patents entered into force in Sweden. The law is based on a controversial EU directive from 1998. The majority of the EU's member states have not adopted this directive and it is uncertain how many will actually do so. It is a pity that the debate surrounding the directive has focused on genetics as such, with agitated declarations that the sanctity of life will be violated if patents on life are allowed or accusations that greedy corporations will force us to pay in order to have children or even being alive.

Actually the directive involves patenting a certain method of treatment or application in order to cure diseases, in the same way as companies have patents on medicines. Already in 1997 an American corporation patented a gene that, if it is present in a woman's genome several times, could cause a significant increase of the risk of hereditary breast cancer.

In Sweden, and in most other countries, you are allowed to patent processes, instruments and newly created products but not what occurs naturally, since it is discovered rather than invented. A patent gives you the right to commercially use an invention with exclusivity for a period of time, in some cases 10-20 years, and then it is free for all. But the practice of patenting genes and genetic inventions is not as widespread in Europe as it is in the United States. One of the reasons that American scientists took the lead and completed the mapping of the human genome was that American legislation enabled the patenting of biotechnical inventions and genes. This is a disadvantage European scientists have had difficulties with, and EU legislation could do well to become clearer on the issue.

The EU directive on legal protection for biotechnical inventions does not exclude patents on genetically modified plants and animals, but it does exclude species-wide ones. New inventions are possible to patent, even if they concern a product that consists of biological material or a process, through which biological material is produced, elaborated or applied. Biological material, isolated from its natural environment or artificially manufactured, can constitute an invention, even if it is present in nature.

Only the patent holder is allowed to utilize the diagnosis or treatment method he has invented, just like the unauthorized use of other patented processes is forbidden. To create an application for a gene through an industrial process (as in the above mentioned case with the gene for breast cancer through a method of diagnosis) is something completely different. Normal procreation is not a patent infringement, both regarding humans and animals. The only time natural procreation could become a patent infringement regards genetically modified animals, that require a permit to be bred, and genetically modified crops.

Intellectual property legislation and patents, in their present form, are not without their problems (exactly how much of the applications are to be included in the patent, for instance?) but that is another debate that is much wider in scope and involves many other areas than just genetics and biotechnology. It would have been better if genetics as such, and the moral controversies in EU regarding biotechnology, had been left out of the debate regarding patents.

If patents in this area are not allowed, or left ambiguous, much of the research will have difficulties reaching a commercial potential, and will leave Europe lagging behind in the pharmaceutics and biotechnology fields. A new medication can cost far more than €400 million to develop, and genetics is an essential part in this research. It would be a severe blow to medical advancements, the curing of diseases and to economic growth in the EU to ignore the problem. Especially since other parts of the world stand ready to take up the work if the EU drops the ball.