TCS Daily

Of Mice and Men

By Richard Braun - August 6, 2004 12:00 AM

A few weeks ago the European Patent Office in Munich finally decided that the Harvard Oncomouse could be patented in Europe. This transgenic mouse has an activated oncogene, which makes it suitable for cancer research.

It was developed in the 1980s at Harvard University and granted the world's first animal patent by the US Patent and Trademark Office in 1988. A pan-European patent was granted by the European Patent Office (EPO) in 1992, following which a coalition of church, environmental and animal protection groups, led by Greenpeace, succeeded in having the patent suspended. They made the point that the patent raised ethical concerns and violated the dignity of living beings.

In the new ruling the breadth of the patent has been somewhat more restricted than in the first application by allowing the patent only to cover the transfer of oncogenes into mice, rather than into any sort of rodent. This restriction is in line with many other patenting decisions of the last few years which no longer grant very broad protection, as was the case ten years ago. This recent decision of the EPO is final and does not allow for any further appeals. However, the case might still be brought to national courts, which could then -- theoretically -- make a different ruling on their national territory.

Patenting organisms is not new. The first patent was granted to Louis Pasteur in 1873 for a yeast "free from organic germs of disease, as an article of manufacture" for improving wine production. Much later, in 1980, a landmark decision was taken by the US Supreme Court in the Diamond v. Chakrabarty case, when it recognized that a transgenic bacterium, able to break down some industrial waste products in the soil, was a "new composition of matter", similar to a new chemical compound. In recent years many patents have been granted world-wide on transgenic animals.

For the biotechnology industry the possibility of having their products patented is essential. Worldwide some 10,000 biotechnology patents are issued every year. For small companies (SMEs) the sale of patents and licenses (and thereby of technical knowledge) to larger pharmaceutical firms is often the sole form of income and therefore patenting is an economic necessity. The aim of the patent is to protect intellectual property (IP), thereby making it attractive for companies to spend money on research and development. Looking at the other side of the coin patent offices need to be careful that they don't allow patents on discoveries taken directly from nature, but only on man-made inventions, a distinction which in practice is not always easy to make.

They also need to avoid honoring very broad claims. Each patent contains a detailed description of a new, original and useful invention, in biotechnology as in any other field of technology. In biotechnology the verbal description of the patent is often accompanied by the deposition of a sample of the new material, for instance a bacterial strain, so that experts can control the invention that was claimed to have been made. The patent holder has a time-limited monopoly on the sale of the patented product. This monopoly usually lasts for 20 years from the moment the invention was made and mostly leads to a practical marketing monopoly of only 10 to 12 years because of the time taken to develop and market the new product.

IP legislation in most countries contains different types of privileges, specific situations where the usual patenting rules do not apply. One is the research privilege, which allows researchers to use patented material for their own research, but not for later commercialization. The second is the farmers' privilege permitting the re-use of home grown seed, even if that seed is patented. This rule is in the European patent legislation and holds for small and medium size farms. Large farms may have to pay a technology fee for re-using patented seed. Most farmers in Europe in fact buy new seed every year, irrespective of the IP regulation: only new seed from a professional producer is covered by a quality guarantee.

Greenpeace and other organizations claim that patenting infringes the animals' dignity. However, this is not the case, since a patent only regulates the commercial use of an invention by others. A patent on an animal (or any other object) does not allow the owner to do anything specific with the animal. To experiment with the patented onco mouse, for instance, a researcher requires the appropriate animal experiment license. The owner of a dog can have it castrated or even killed, irrespective of whether or not that dog was patented. So a patent on an animal has no consequence for its wellbeing. Ownership legislation is much more intrusive than patent legislation. Those claiming the contrary either have not understood the principles of patent legislation or aim to mislead the public.

Of course life cannot be patented, but with the new knowledge in the life sciences, cells and organisms have to be patentable, as long as certain conditions of inventiveness are fulfilled. Investment in research and development in biotechnology depend to a large extent on the legal possibility of patenting living organisms.


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