Patent protection of living organisms
Everyone probably is familiar with the concept of patents, where the inventor gets an exclusive right (for 20 years or so) towards utilizing a particular thing (s)he invented, in exchange for making his/her invention public. But how does this work for living organisms that were changed by genetic engineering? Living organisms in general were not patentable because they were not invented by someone, but if genes get inserted into an organism one may claim that the resulting "beast" in a sense is created by the person who did the transformation. It has been a long struggle in US courts, but in the early eighties the decision was made by the Supreme Court that genetically engineered organisms indeed would be patentable, ending a long period of uncertainty.
Most industries viewed the patentability of a genetically engineered organism as good news, and certainly there is more incentive for biotechnology industries to invest in research and development if they know that they can patent their product and expect reasonable profits for a number of years if their product is good. The rapid development of biotechnology in the last decade almost certainly is due in part to patent protection of genetically altered organisms. Venture capitalists (people who wish to invest in risky projects with the potential for huge profits or failures) have invested heavily in biotechnology companies after the Supreme Court decision, and this venture capital has kept many biotech companies alive until they started marketing their products. In many cases, five or more years pass between initial product development and actual marketing: processes need to be scaled up, certifications and approvals need to be granted, etc. In many cases, however, very promising biotechnology start-ups are taken over by bigger companies, sometimes even before the first product is being marketed, and less promising startups never make it to their first marketed product.
Gene technology laws in other countries
Particularly in Western Europe, virtually every country has its own set of laws regulating gene technology. The strictness of the laws is variable. For example, in France the laws are relatively lax, whereas Germany's laws used to be so complex and unworkable (for example, biotech research and production were regulated separately, and all industrial research plans had to be submitted for public approval) that most German multinationals moved their biotech R&D to the USA or other countries with a better "climate" for such research. However, Germany now also has a uniform and simpler Genetic Technology law, under which most approval procedures for experiments involving gene technology has been significantly simplified. The new law specifies a series of safety levels which are determined by the classification of risks associated with the parental or recipient microorganisms or cells used for recombinant DNA work. It is expected that the new Gene Law will lead to a significant interest of international biotech companies to open research and development divisions in Germany: after reunification and related economic problems, the country is again one of the economic leaders in Europe.
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Center for Bioenergy & Photosynthesis
Arizona State University
Room PSD 209
Tempe, AZ 85287-1604
13 February 2006
phone: (480) 965-1963
fax: (480) 965-2747