PATENTABILITY OF THE LIVING

Presentation
The dawn of biotechnology began in 1978-1980 with essentially university research and on small structures, the future “biotech start-ups”.

From the beginning, it was clear that the dominant field in biotechnology could be pharmaceuticals. However, the major players in pharmaceuticals do not truly believe in the future of this technology, or do not wish at all developing this internal technology. For university laboratories and start-ups, the development of a medecine can of course not be considered. From the beginning these structures knew that they will have to hand over to others.

But how to hand over in the best way?
It is easy; it is necessary to be able to negotiate with the major players on the best terms and in this case it is necessary to have protected one’s grey matter by the only means available, industrial property and contracts.

This explains the development of highly aggressive industrial property and contract strategies, not only in universities but also in public organisms and in start-ups.

The CNCPI considers that the position of the French goverment on the opposition to the transposition of the Biotechnology Directive, which made official the patentability of human genes under certain conditions, is not going in the direction of European harmonisation or oflegal security. In addition, it might discourage in the short term foreign investments in France in biotechnology.

The CNCPI wishes to recall the importance of industrial property in the evaluation of start-ups, in particular the need for an industrial property portfolio audit both for evaluating the assets of the company and the possibilities of exploitation.

Nowadays, investors consider that the first criteria for investment in biotechnology is a strong patent position, that is to say strong positioning in industrial property, the second criterion being management.
The CNCPI states the entire importance of professional and rigorous procedures with regard to industrial property upstream and downstream of biotechnology research projects.

Questions and answers

Are patents on life granted?
“Patents on life” do not exist. Life as a creation is not protectable. It is not the living being as such that is patented, but a technical teaching. The patent does not confer any property right over the biological material. It merely allowsthe proprietor to prevent third parties from using his/her invention commercially. The patent is an excluse right. It is distinguished fundamentally from a right of property over a living being. In addition, the patent does not speak as to whether the patented invention may be the subject of commercial use.

Are micro-organisms patentable?
Microbiological processes and the products obtained by these processes are patentable. Patents can be granted both for the use of micro-organisms with a view to obtaining particular products and the production of new micro-organisms as a manufacturing process. The first patent for a micro-organism was granted 128 years ago: it was in 1873 that Louis Pasteur obtained a patent relating to an isolated yeast.

Are plants and animals patentable?
Provided that the general conditions are fulfilled (novelty, inventive step, industrial application), patents can also be granted for inventions relating to plants and animals. It is however not the living being which is directly the subject of the patent but a technical teaching. This was confirmed at a European level by the decision of 20 December 1999 of the Enlarged Board of Appeal (Transgenic plant/Novartis II G 1/98; OJ EPO 2000,111).

What are the aims of the European directive on legal protection of biotechnological inventions?
The aim of directive 98/44/EC of the European Parliament and the Council of 6 July 1998 relating to the legal protection of biological inventions is to harmonize the various national patent laws of the member states of the union concerning the patentability of biotechnological inventions. The consequence of this will be to increase legal security within the union, to reinforce the position of the European economy in international competition and to promote innovation in the field of biotechnology.
The directive specifies which law is applicable to biotechnological inventions on the basis of the granting practice of the European Patent Office and national offices and courts. By delimiting clearly certain questions, the directive prevents case law and practice in this field from developing in an excessively divergent way within the European Union.

Does the European directive on the legal protection of biotechnological inventions bind the member States of the EU?
Directive 98/44/EC of the European Parliament and Council of 6 July 1998 relating to the legal protection of biotechnological inventions came into force on 6 July 1998 and was to be implemented in the national law of the member States by 30 July 1998.
At the moment, only six of them (Denmark, Finland, United Kingdom and Ireland, Spain and Greece), have incorporated the directive in their national law. In the other States, the legislative process is not yet finished. Since 30 July 2000, the directive has however been directly applicable in other member States of the EU.