The biotechnology directive and its relationshIP to the EPC

Authors: Claire Baldock and Oliver Kingsbury

Introduction

On 16 June 1998 the Council of Ministers of the European Community passed Directive No 98/44/EC on the legal protection of biotechnological inventions. The Directive came into force on 30 July 1998 when it was published in the Official Journal of the European Communities¹ and Member States now have until 30 July 2000 to amend their laws in accordance with its provisions.

The Directive recognises the increasingly important role of biotechnology and genetic engineering in industry and the necessity of adequate legal protection for research and development in these areas so that they may be profitable. In this respect, it also acknowledges the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), to which the European Community and its Member States are signatories. TRIPS specifically provides that patent protection must be guaranteed for products and processes in all areas of technology.

The Directive also recognises the requirement for clarification of Member State’s patent laws as they relate to biotechnological inventions. In particular, it provides some guidance on the following issues: the patentability of biological material per se, the difference between inventions and discoveries with regard to the patentability of certain elements of human origin, the interpretation of legislative exclusions to patentability and the scope of protection provided by a patent on a biotechnological invention.

In response to the rejection of the original Directive by the European Parliament in 1995 due to its insufficiency in addressing ethical issues, the present Directive also makes some provisions regarding the moral and ethical issues of patent law in the area of biotechnology. However, although it includes an indication of inventions considered to be contrary to ordre public or morality, it also sets out to distance itself from these issues by re-affirming the fact that substantive patent law cannot replace national, European or international laws which may impose restrictions or prohibitions on the use or commercialisation of biotechnological research.

The present discussion will examine the origins of the Directive and will attempt to assess its implications for patent practice under Member States’ national laws and, perhaps more importantly, under the European Patent Convention (EPC). It should be emphasised at this point that the Directive is binding only on the EU Member States and does not necessarily have any direct effect on the EPC. Furthermore, it does not require the EU Member States to amend the EPC in accordance with its provisions, indeed it cannot do so since not all EPC Contracting States are members of the EU. That said, the European Parliament and the Council of the EU based many provisions of the Directive, in particular those relating to patentability, on the text of the EPC in view of its interpretation by the EPO and its various Boards of Appeal. Thus, an understanding of the origins of the provisions of the Directive is inextricably linked to an appreciation of developments in the interpretation of the EPC as it relates to biotechnological inventions. Furthermore, it is now clear that the relationship of the EPC to the Directive will not be restricted merely to one of historical background.

In February 1999, the EPO Administrative Council proposed some amendments to the Implementing Regulations of the EPC which were intended to ensure that its interpretation is brought into line with the provisions of the Directive. After some further amendments, these proposals were finally introduced into the Implementing Regulations of the EPC as new rules 23b to 23e, taking effect from 1 September 1999. Furthermore, on 20 December 1999, the highest authority of the EPO, the Enlarged Board of Appeal, handed down its decision in G1/98, Novartis². As will be explained in more detail later in this article this decision was extremely important in terms of the relationship of the Directive to the EPC.

Although the decisions therein were reached without reference to the Directive, the points of law in issue were addressed in a manner consistent with its provisions. Thus the process appears to have come full circle, a Directive which was shaped by previous developments in EPO case law now appears in turn to be influencing current developments in the implementation and interpretation of the EPC. That said, it should be noted that the Implementing Regulations of the EPC do not carry the same legal weight as the provisions of the EPC itself and that, although they form an integral part of the EPC and must be taken into account for its interpretation, where conflict between the Implementing Regulations and the EPC arises the provisions of the EPC must take precedence. The amendments to the Implementing Regulations and the extent to which they achieve the goal of implementing the provisions of the Directive will be considered at appropriate points in the ensuing discussion. In a similar vein, even decisions of the Enlarged Board have been overturned where they have been considered to incorrectly interpret the provisions of the EPC.

Patentability

a) Patentable Inventions

The provisions of the Directive with regard to the allowability of patents on “biological material” are set out in Articles 3, 5(2) and 5(3) which are reproduced below (although Article 5(1) obviously relates to an exclusion from patentability it is included as a backdrop to contrast with the provisions of Articles 5(2) and (3)). In the context of the Directive “biological material” is defined as “any material containing genetic information which is capable of reproducing itself or being reproduced in a biological system”. This definition does not encompass, for example, proteins.

Article 3

1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used .

2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

Article 5

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.

Article 5

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.