Background

Following a number of years of debate in the Council and European Parliament, the Biotech Directive was adopted in July 1998 and came into force in July 2000. The Biotech Directive was drafted with the aim of establishing a unified European approach to biotechnology patents. The drafters of the Directive were aware that the biotechnological sector was, and still is, a rapidly developing sector, and that there was a need to establish a sound legal framework which would allow European businesses to develop and market products and processes arising from biotech inventions.

Introduction

The Biotech Directive has two components: articles and recitals. The articles are directly binding on Member States.  Recitals provide a context in which both Member States and the courts can interpret the articles, and are unenforceable unless also contained in an article.

Current Member States

As of June 2005, 21 Member States of the EU, including Ireland, have implemented the Biotech Directive. EU Member States Italy, Luxembourg, Lithuania and Latvia have not yet implemented the Directive.

Summary of the key provisions of the Biotech Directive:

Patentability of biotech inventions:

The Biotech Directive builds on the general principle of patent law that inventions that are new, non-obvious, and have an industrial application can be patented. It provides that this same set of rules applies to biological materials, and provides the following guidelines relating specifically to biotech inventions:-

Biological material is patentable. Biological material is defined as “any material containing genetic information and capable of reproducing itself or being reproduced in a biological system”.

Discoveries vs Inventions: The Biotech Directive provides a distinction between a non-patentable discovery and a patentable invention. Specifically, the Directive states that “the simple discovery of one of … [the human body’s] elements or one of … [the human body’s] products, including the sequence or partial sequence of a human gene, cannot be patented … a mere discovery cannot be patented”. However, the Directive also states that “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”.  The rationale behind allowing the patenting of genes is that the gene is isolated from the human body by a technical process which nature is incapable of accomplishing itself and that the rights of a patent do not extend to the human body or the element in its natural environment. Crucially, a gene can only be patented if its function and industrial application are disclosed in the patent application as filed. In other words, “a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention”.

Inventions relating to plants shall be patentable if the technical feasibility of the invention is not confined to a particular plant variety.

Patents may be granted for inventions relating to animals if the application of the invention is not technically confined to a particular animal variety.

Currently, the patentability of human stem cells and the cell lines obtained from them is the subject of heated debate. Stem cells are cells with the ability to change into any cell type of a given organism, or at least into any cell type of a certain class of cells (e.g. into different blood cells). They offer the prospect of developing new methods to repair or replace tissues or cells and thus to treat degenerative diseases like multiple sclerosis. In the light of the current state of knowledge, the most promising stem cells still seem to be those derived from human embryos. This makes the patentability of inventions relating to human stem cells a highly sensitive topic as discussed in “Recent Developments”.

Exclusions from Patentability:

The Directive establishes a general principle of exclusion for inventions whose commercial exploitation would be contrary to ordre public or morality. Guidance for interpreting this principle is mainly provided by the following specific list of exclusions provided in the Directive. These “inventions” are specifically excluded from patentability by the Directive:

• Processes for cloning human beings;
• Processes for modifying the germ line genetic identity of human beings;
• The use of human embryos for industrial or commercial purposes;
• Processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

For information on recent developments concerning the Biotech Directive, click here.