Patent law in the field of biotechnology and genetic engineering: implementation report (2002)

This document is the Commission's first annual report aimed at evaluating the implementation of Directive 98/44/EC on the legal protection of biotechnological inventions. It examines the development of patent law in the field of biotechnology and genetic engineering, and identifies and evaluates problems and sensitive issues that have recently arisen.

ACT

Commission Report of 7 October 2002, Development and implications of patent law in the field of biotechnology and genetic engineering COM(2002) 545 final [Not published in the Official Journal].

SUMMARY

Background and general objective

The biotechnology sector was identified by the Stockholm European Council in March 2001 as one of the most promising in terms of economic development and employment. There has, in fact, been a real boom in biotechnological inventions with the discovery of very encouraging new techniques for therapeutical applications and food production. In this context, the European legislator felt it necessary to keep pace with these developments by establishing a secure legal framework allowing European companies to develop and market the new products and processes arising from genetic engineering. This is the context in which to place Directive 98/44/EC on the legal protection of biotechnological inventions, which was adopted after almost ten years of discussions within the Council of Ministers and the European Parliament.

Provision is made for this report in Directive 98/44/EC which stipulates that the Commission should send the European Parliament and the Council an annual report on the development and implications of patent law in the field of biotechnology and genetic engineering. This report also forms part of the follow-up to the Commission Communication of 23 January 2002 entitled "Life sciences and biotechnology - A Strategy for Europe"[PDF], which aims to promote biotechnology within a flexible regulatory framework and to ensure consistency across the different policies and sectors involved in this field.

The report examines the core provisions of Directive 98/44/EC with the aim of determining whether the patent system is effective in meeting the needs of researchers and businesses.

The current situation in Europe

At the time of drafting this report, only six Member States had transposed Directive 98/44/EC into their national legal systems: Denmark, Finland, Ireland, the United Kingdom, Greece and Spain. This transposal is, however, essential in order to avoid any discrepancies between the different national legislations, especially since if such a situation were to continue, the development of biotechnology in Europe might slow down considerably.

The main provisions of Directive 98/44/EC have been incorporated into the Implementing Regulations to the European Patent Convention by a Decision of the Administrative Council of the European Patent Organisation. This incorporation of Community law by the Organisation is particularly important. The European Patent Convention lays down a single procedure for examining applications for patents, which makes it possible to have a whole range of national patents governed by national and Community law.

In 1998, the Netherlands, with the support of Italy and Norway, brought an action for annulment of Directive 98/44/EC before the Court of Justice of the European Communities. The application by the Netherlands put forward six pleas, relating in particular to the incorrect legal basis chosen for the Directive, the breach of the principles of subsidiarity and legal certainty, and the breach of obligations in international law. In October 2001, the judgment of the Court dismissed the action.

The compatibility of the Directive with relevant international agreements in this field

The Directive is compatible with existing international Treaties in the field of biotechnology. Nonetheless, the work being carried out at international level within WIPO (the World Intellectual Property Organisation) on the draft SPLT (Substantive Patent Law Treaty) is particularly likely to have an impact on Directive 98/44/EC. The new draft treaty is intended to establish, at international level, binding provisions applicable to substantive patent law. At the current stage in the negotiations, the provisions of the Directive that might be affected by this work are those relating to industrial application and those relating to the deposit of a biological material with a recognised institution.

The patentability of inventions relating to plants and animals

The Directive distinguishes between plants and animals which are patentable and plant and animal varieties which are not. The reason for this differentiation lies in the means of achieving the product concerned: a plant or animal variety is generally obtained by essentially biological processes, while transgenic plants and animals are obtained through non-biological processes forming part of genetic engineering.

With regard to plants, the Directive reiterates that, while plants are patentable, plant varieties are not and are protected by plant variety rights. In delivering its judgment of October 2001, the Court of Justice pointed out that, under Article 4 of the Directive, a patent cannot be granted for a plant variety, but may be for an invention if its technical feasibility is not confined to a particular plant variety. The Court also concluded that a genetic modification of a specific plant variety is not patentable but a modification of wider scope, concerning, for example, a species, may be protected by a patent.

With regard to animals, Directive 98/44/EC stipulates that animal varieties cannot be patented. However, inventions relating to animals can be protected by patent if the technical feasibility is not confined to a particular animal variety. Amongst the many patents granted in the field of biotechnology since the adoption of the Directive in July 1998, some of those granted by the European Patent Office have provoked strong reactions from the public. One such case is a patent granted to the Seabright company relating to the creation of a transgenic fish, which gave rise to a written question to the Commission from a Member of the European Parliament. The question related in particular to the compatibility of granting this patent with the exclusion from patentability of animal varieties. In its reply, the Commission pointed out that one of the provisions of the Implementing Regulations to the European Patent Convention - which takes over the substance of the provisions of Directive 98/44/EC - lays down that a patent for an invention relating to an animal may be obtained if the claimed invention involves a technical measure which is not confined to a particular animal variety. This appeared to be the case with the patent granted to the Seabright company.

Finally, the Directive expressly makes provision for the patentability of microbiological processes and products directly obtained from such processes.

The patentability of inventions relating to elements isolated from the human body

Under Directive 98/44/EC, the human body, at the various stages of its formation and development - thus including the embryo -, is not patentable. It follows that neither the discovery of a sequence of a gene, nor the crude data relating to the human genome constitute patentable inventions. Only inventions which combine a natural element with a technical process enabling it to be isolated or produced for an industrial application can be the subject of an application for a patent.

In this field, two patents granted to the company Myriad Genetics gave rise to numerous questions from Members of the European Parliament to the Commission. These are patents which are based on an invention which allows screening for cancer of the breast and ovaries in women. The questions focused principally on the dangers which granting the patents might pose for the freedom of research in the EU, as well as on the high costs to European patients of access to the technology offered by the patents.

In answer to these questions, the Commission stressed that Directive 98/44/EC was not intended to call into question the freedom of research in Europe. It reiterated that, if research results were commercialised and these results used a technique which has already been patented, a sub-licence should be obtained from the holder of the patent. In addition, most national legislation in the Member States had adopted the principle of exempting prior use, which allows anyone who has already used the invention in the European Community, or had made effective preparations for such use before the patent was filed, to continue such use or to use the invention as envisaged in the preparations.

Exclusion from patentability of inventions whose commercial exploitation would be contrary to ordre public and morality

Directive 98/44/EC excludes from patentability inventions whose commercial exploitation would be contrary to ordre public or morality. Contrary to the arguments advanced under the action to annul the directive, the Court of Justice considered that the directive was sufficiently precise on this point and that the danger of wide differences of interpretation was not therefore a valid argument. The Court also considered that the national administrative and court authorities in the Member States were best placed to evaluate the validity of a biotechnological invention with regard to the ethical, sociological or philosophical context of each country.

The Directive specifies four explicit exclusions from patentability, which was not the case in the body of law applicable to patents. These are processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, and the use of human embryos for industrial or commercial purposes. These explicit exclusions are a clear source of legal certainty.

Recent developments in the field of biotechnology and human stem cells show great promise for cures, particularly in the treatment of degenerative diseases. This is the case with parthenogenesis, which is defined as the development of an ovule without there having been any fertilisation by a spermatozoid. The Commission report also emphasizes the controversial status of cell lines obtained from multipotent cells which may themselves be created by "therapeutic cloning". These cell lines also, however, pave the way for considerable progress, which is the reason why the Commission suggests that discussions should continue on this question and on measures which could be taken to encourage this type of research.

Asked by the President of the Commission to look into the ethical aspects of the patentability of inventions involving human stem cells, the European Group on Ethics issued its opinion in May 2002. In it, the Group insists on the importance of ensuring a fair balance between the interests of the inventor and those of society, and hence of defining the conditions and limits for the patentability of stem cells. The protection conferred by a patent should relate to precisely described industrial applications, and not to a wide range of potential applications.

Conclusion

The Commission report concludes that the European legislator has endeavoured to create a functional system which respects the ethical principles recognised within the European Community. This report identified two key topics:

• the scope to be conferred to patents on sequences or partial sequences of genes isolated from the human body;
• the patentability of human stem cells and of cell lines obtained from them.

These two topics will be investigated by a group of independent experts made up of professionals in the field of patents (scientists, lawyers, economists) who are highly qualified in the field of biotechnological inventions and genetic engineering. The group will also assist the Commission in defining the priority topics to be covered in subsequent reports.

RELATED ACTS

SECOND REPORT

Commission report of 14 July 2005, Development and implications of patent law in the field ofbiotechnology and genetic engineering [Not published in the Official Journal]. This second annual report presents the latest major developments that have taken place since the first report was published. It highlights the questions concerning the patenting of gene sequences isolated from the human body and the patentability of inventions relating to stem cells. It also reports on the implementation of the Directive.

DIRECTIVE 98/44/EC

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions [Official Journal L 213 of 30 July 1998]. The Directive clarifies the distinction between what is patentable and what is not patentable. In particular, it confirms that the human body at the various stages of its formation and development, as well as processes for human cloning and for modifying the germ-line genetic identity of human beings, may not be regarded as patentable inventions.

Last updated: 07.09.2005