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How can living organisms be protected ?

 To download the detailed article, "The Patentability of Living Organisms", co-authored by Béatrice Orès, Fabienne Paris, and Lionel Vial, French Patent and Trademark Attorneys, click here (only in french).

Life as a form of creation cannot be protected: there are no “patents on life”. The living thing itself is not what is patented, but a technical teaching. The patent does not confer property rights to the biological matter. It only enables the patent owner to prohibit third parties from commercially exploiting his invention. The patent is a right to exclusivity. It is fundamentally different to a right of ownership of a living thing. Moreover, the patent does not specify whether the invention may be used in a commercial capacity.

The patentability of genes

In Europe, the patentability of biological matter is set forth by Directive 98/44/CE, the European Union directive on the legal protection of biotechnological inventions. This Directive defines biological matter as being matter containing genetic information and which is self-reproducing or reproducible in a biological system. It provides that an isolated element in the human body or otherwise produced by a technical procedure, including the sequence or partial sequence of a gene, is patentable, even if the structure of that element is identical to that of a naturel element, on the condition that the industrial application of that genetic sequence be completely disclosed in the patent application.

The provisions of this Directive have been transposed in French law in Article L. 611-18 of the Intellectual Property Code. French law is more restrictive with regard to protection, as the directive specifies that "only an invention constituting the technical application of a function of an element of the human body may be protected by patent" and that "this protection only covers the element of the human body in so far as this is necessary to the realisation and exploitation of that particular application”. 

The patentability of embryonic stem cells

In Europe, the use of a human embryo for industrial or commercial purposes was excluded from patentability as of July 1998.
In 2008, the Enlarged Board of Appeal of the European Patent Office (EPO) confirmed that a European patent could not be delivered for products which, at the date of patent application filing, could only be obtained by destroying human embryos (decision G 2/06).

In 2011, the Court of Justice of the European Communities (ECJ) also ruled that European Union legislation “excludes the patentability of an invention once the technical teaching on which the patent application is based requires the destruction of human embryos or their use as raw material, whatever the stage at which they intervene and even if the description of the technical teaching applied for does not mention the use of human embryos” (decision C-34/10).

Whatever the future technological advances, the European Patent Convention (EPC), can provide a sound legislative basis for placing the interest of patenting an invention in perspective with ethical values (Article 53(a) CBE).
With regard to the particular area of stem cells, the territorial monopoly of exploitation which confers a patent in Europe also offers the advantage of exercising a certain control over persons authorised to implement the invention.

Are microorganisms patentable?

Microbiological procedures and products obtained from these procedures are patentable. Patents may be delivered both for the use of microorganisms in view of obtaining specific products as well as for the production of new microorganisms as manufacturing processes. The first patent for a microorganism was delivered 128 years ago: it was in 1873 that Louis Pasteur obtained a patent for an isolated yeast.

The patentability of plants and animals

As long as the general conditions of patentability are met (novel, inventive activity, industrial application), patents may also be delivered for inventions having to do with plants and animals, provided that these inventions do not target animal races or vegetable varieties, nor, in keeping with the position of the French Patent and Trademark Office (INPI), plants and animals obtained from essentially biological procedures, i.e. procedures primarily based on sexual breeding and desired trait selection. Furthermore, essentially biological procedures for obtaining plants and animals are also excluded from patentability.

Patent law and genetic resources 

A European regulation was adopted to combat bio-piracy and guarantee a share of the benefits from the commercial exploitation of genetic resources (EU Regulation 511/2014 of 16 April 2014). The transposition of this European regulation in France is ongoing in the draft of bill N°608 to restore biodiversity, nature, and the environment. This future law could introduce the obligation to declare to INPI all genetic resources or associated traditional knowledge of which use had been made in the framework of an application for a French patent.

Useful links
Economic Analysis Council (CA)
National Institute for Agronomic Research
Organisation for Economic Cooperation and Development (OECD)

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