The patentability of biotechnological inventions: the European Commission’s second 16c report

Publié le 23/08/2005 par Paul Van den Bulck

On 14 July 2005, the European Commission submitted its second report (Commission document COM(2005) 312 final, Brussels, 14.07.2005) pursuant to Article 16c of the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (hereafter ‘Directive’ – OJ L 213, 30.7.1998). Hereafter we briefly outline the comments made in this Commission document.…

On 14 July 2005, the European Commission submitted its second report (Commission document COM(2005) 312 final, Brussels, 14.07.2005) pursuant to Article 16c of the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (hereafter ‘Directive’ – OJ L 213, 30.7.1998). Hereafter we briefly outline the comments made in this Commission document.

Article 16c of the Directive indeed states that:

“The Commission shall send the European Parliament and the Council […] annually as from the date specified in Article 15(1), a report on the development and implications of patent law in the field of biotechnology and genetic engineering.”

This second report comments in particular on (A) the scope of patents on sequences or partial sequences of genes which have been isolated from the human body, (B) the patentability of human stem cells and cell lines obtained from them and (C) some latest developments occurred since the publication of the first 16c report (http://europa.eu.int/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf).

The scope to be attributed to patents on partial sequences or sequences of genes which have been isolated from the human body

This issue pertains to the problem of the sometimes very broad patents relating to DNA sequences covering a whole of applications and functions. The second 16c report indeed addresses the question whether patents on DNA sequences should be allowed according to:

1. the classical model of patent claim, i.e. the inventor claims an invention which covers possible future uses of that sequence; or

2. the “purpose-bound protection” model, i.e. a restriction of the patent so that only the specific use disclosed in the patent application can be claimed?

Firstly, one can note that the “purpose-bound protection” model is not an entirely new concept under European law: second medical patent claims for known medical substances (the so called ‘Swiss claims’) have been allowed for, by inter alia the European Patent Organization (EPO), if these claims are purpose-bound (‘the use of a substance X for the manufacture of a product to achieve function Y’ – EPO Enlarged Board of Appeal, 5 December 1994, G05/83 EISAI Co Ltd.).

When transposing the Directive into their national legislation, France and Germany have provided for such a purpose-bound protection as regards to inventions concerning material isolated from the human body (France) and human/primate gene sequences (Germany).

Despite these elements, it is stated in the report that the European Commission does not at present takes a position on the validity of transposition of the Directive, by the EC Member States, according to the choice between classical and limited scope of protection for gene sequences.

The following (conflicting) arguments have hereby been taken into consideration by the Commission:

1. None of the articles of the Directive falling under the chapter ‘scope of protection’ addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. However, is has been invoked that Article 5(3) of the Directive, providing that the industrial application of a gene sequence is to be disclosed in the patent application, can be considered to be more than a mere repetition of a standard requirement of patent law. Therefore, one could subsequently argue that this article, as well as recitals 23 and 25 of the Directive, at least provide for a basis for a limited scope of protection.

2. The report states that a Group of Experts has been set up in order to advise the Commission on the preparation of future 16c reports through the examination of important issues relating to biotechnological inventions. According to the report, a majority of this Group of Experts have felt that there were no differences between DNA sequences and chemical substances which would justify different treatment as regards the scope of patent protection.

3. With regard to the economic question whether is it more valuable to society to allow the first inventor a broad scope of protection so others which build on this invention should have to seek a license, or whether a patent on a gene sequence should be limited in scope to allow future uses of such sequences to be patented freely, it is reported that economic evidence is hard to come by and the arguments do not relate solely to gene sequence patents as distinct from any other field of technology. Therefore, the Commission launched a study analyzing the extent of human DNA patenting in Europe and its potential consequences on research and innovation.

4. As it has been several years since the Directive was first proposed, the Commission considers it questionable whether a further refining of the scope of protection of gene sequence patents in the light of divergences between national legislations will have any significant effect on the actors in the field.

The patentability of human pluripotent embryonic stem cells and stem cell lines obtained from them

The report further mentions that, at this moment, human embryonic stem cells have the potential to differentiate into all cell types in the body and, at present, it are only the pluripotent stem cells that can be readily isolated and grown in culture in sufficient numbers to be useful.

Besides pluripotent stem cells, one can also note the existence of totipotent stem cells. Whereas totipotent stem cells are capable of developing into a human being, pluripotent stem cells are not so capable.

The Commission is of the opinion that the Directive is clear in relation to totipotent stem cells: since each such cell could develop into a human being on its own, the restriction of Article 5(1), providing that the human body at the various stages of its formation and development cannot constitute a patentable invention, applies. In other words, according to the Commission, “it appears that totipotent stem cells should not be patentable, on grounds of human dignity”.

As regards to pluripotent embryonic stem cells, the Commission finds the situation more complex. Indeed, in view of “the clear divergences which currently exist between Member States as regards the acceptability of research relating to embryonic stem cells, the continuing and rapid developments in this field, and the fact that the Directive itself provides for Member States to refuse patents on grounds of ordre public or morality”, the Commission refrains from giving a further definition or to provide for further harmonization in this area. The latter hereby confirms that “there is no immediate answer to the question of the patentability of embryonic pluripotent stem cells.”

Latest developments

As regards the state of progress with transposition of the Directive into the national legislation of the EC Member States, the Commission reports that 21 Member States have notified the Commission their legal instruments implementing the Directive. In this respect, we mention the rather recent transposition of the Directive into the Belgian patent law by means of the Act of 28 April 2005 (Moniteur belge, 13 May 2005).

The Commission finally reports that a Council Regulation amending Regulation 2100/94 on Community plant variety rights (Council Regulation (EC) N° 2100/94 of 27 July 1994 on Community plant variety rights, OJ L 227, 1.9.1994) has been adopted (Council Regulation (EC) N° 873/2004 of 29 April 2004 amending Regulation (EC) N° 2100/94. on Community plant variety rights, OJ L 162, 30.4.2004) in order to render Article 29 of the latter Regulation 2100/94 and Article 12 of the Directive mutually compatible. These provisions deal with cross-licenses on patent and plant variety rights.