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Decision n° 2004-498 DC of July 29th 2004

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The Bioethics Act

On July 9th 2004, the Constitution Council received a referral, pursuant to paragraph 2 of Article 61 of the Constitution, for review of the constitutionality of the Bioethics Act, from Mr. Jean-Marc AYRAULT et al........ Deputies
and on July 12th 2004, from Mr. Claude ESTIER et al. ... , Senators

THE CONSTITUTIONAL COUNCIL,

Having regard to the Constitution;

Having regard to Ordinance n° 58 1057 of November 7th 1958 as amended (Institutional Act on the Constitutional Council);

Having regard to the Treaties instituting the European Communities;

Having regard to the Treaty on European Union;

Having regard to Directive 98/44/EC of the European Parliament and Council dated July 6th 1998 on the legal protection of biotechnological inventions;

Having regard to the Code of Intellectual Property;

Having regard to the decision of the Court of Justice of the European Communities dated October 9th 2001 (case C-377/98) ;

Having regard to the observations of the Government registered on July 21st 2004;

Having regarding to the observations by way of rejoinder submitted by the Deputies making the first referral, registered on July 23rd 2004;

Having regard to the observations by way of rejoinder submitted by the Senators making the second referral, registered on July 23rd 2004;

Having heard the Rapporteur;

ON THE FOLLOWING GROUNDS

1.The parties making the two referrals dispute the constitutionality of Section 17 of the Bioethics Act;

2. Article L611-18 inserted in the Code of Intellectual Property by A II of said Section 17 of the Act provides that " The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot be patentable inventions. Only an invention constituting the industrial application of a function of an element of the human body may be patentable. The protection afforded by a patent only covers an element of the human body to the extent necessary for the achievement and exploitation of said industrial application. Said industrial application must be precisely described in practical terms in the application for the patent. In particular the following are not patentable d) Sequences or partial sequences of a gene as such"; that pursuant to Article 613-2-1 inserted into said Code by A III of Section 17 : " The scope of an application for a patent covering a human gene sequence is limited to the part of this sequence which is directly connected with the specific function explained in practical terms in the description. - Rights created by the granting of a patent including a gene sequence cannot be invoked against a later application for a patent involving the same sequence if said application itself meets the conditions of Article L 611-18 and demonstrates a different particular industrial application of this same sequence ";

3. According to the parties making the two referrals, these provisions disregard Article 11 of the Declaration of Human and Civic Rights of 1789; they argue that " including elements of the human body in the scope of a patent ... would lead to the coming into being and developing of patenting of products which create interdependencies as regards the first patent-holder ... ", that, to this extent, the requirement of pluralism, which far from being restricted to the sole political field "also holds good for scientific knowledge" would be adversely affected; they add that "the disregarding of Article 11 of the Declaration of 1789 cannot be explained away by the need to transpose into domestic law those Directives referred to in article 88-1 of the Constitution";

4. Article 88-1 of the Constitution provides : "The Republic shall participate in the European Communities and in the European Union constituted by States that have freely chosen, by virtue of the treaties that established them, to exercise some of their powers in common"; thus the transposing of a Community Directive into domestic law results from a constitutional requirement with which non-compliance is only possible by reason of an express contrary provision of the Constitution; that in the absence of such an express contrary provision, the European Community judge, upon an application for a preliminary ruling, is alone competent to monitor the respect by a Community Directive of both the powers set forth in the treaties and the fundamental rights guaranteed by article 6 of the Treaty on the European Union.

5. Pursuant to Article 5 of the Directive dated July 6th 1998 referred to hereinabove : "1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. 3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application"; the Court of Justice of the European Communities, asked to rule on an application for annulment of the Directive referred to hereinabove, held in its decision dated October 9th 2001 referred to hereinabove, that such provisions do not allow the discovery of a DNA sequence to be patentable "as such"; the protection of inventions envisaged by the Directive covers only the result of inventive, scientific or technical work, and extends to biological data existing in their natural state in human beings only where necessary for the achievement and exploitation of a particular industrial application ";

6. Article 11 of the Declaration of 1789 provides : "The free communication of ideas and opinions is one of the most precious rights of man. Any citizen may therefore speak, write and publish freely, except what is tantamount to the abuse of this liberty in the cases determined by Law"; this liberty is also protected as a general principle of Community Law by Article 10 of the European Convention on Human Rights and Fundamental Freedoms;

7. The disputed provisions merely draw the necessary conclusions from the unqualified and precise provisions of Article 5 of the Directive referred to hereinabove and upon which it is not the task of the Constitutional Council to make any ruling; consequently, the argument raised by the parties making the referral cannot usefully be raised before the Council;

8. The Constitutional Council is not therefore required proprio motu to examine the question of whether or not such provisions constitute a violation of the Constitution

HELD

Article 1 : Section 17 of the Bioethics Act is declared constitutional

Article 2 : This decision shall be published in the Journal Officiel of the French Republic.

Deliberated by the Constitutional Council sitting on July 29th 2004 composed of Messrs and Mesdames Pierre MAZEAUD, President, Jean-Claude COLLIARD, Olivier DUTHEILLET de LAMOTHE, Valéry GISCARD D'ESTAING, Jacqueline de GUILLENCHMIDT, Pierre JOXE, Jean-Louis PEZANT, Dominique SCHNAPPER, Pierre STEINMETZ and Simone VEIL.