After ten years of wrangling between the EU Commission (representing the interests of the biotechnology sector) and the EU Parliament (representing various interest groups opposed to the idea of "patenting life"), the EU Biotechnology Directive ("the Directive") finally came into force in July 1998 and was due to have been implemented by the EU Member States by July 2000. 1
The EU Commission first put forward the original proposal for the Directive back in 1988. At the time, it was but one part of the Commission's programme to ensure that Europe's nascent biotechnology sector did not fall behind those of the US and Japan. For instance, in the US the Supreme Court decision in Chakrabarty2, a case concerning the patentability of a genetically engineered bacterium, in 1980 heralded a flood of US patents granted in the biotechnology field. The Commission was concerned that certain features of European patent law would create obstacles to the grant of European patents in the biotechnology field. The purpose of the Directive was therefore to ensure that these potential obstacles were removed or at least their impact was reduced.
However, as demonstrated below by reference to the issues of (1) the extent to which ethical considerations should play a part in the grant of biotechnology patents; (2) the overlap between the plant variety rights and patent systems; and (3) the so called "product of nature" problem, the elapse of time between the original proposal for and the final version of the Directive has meant that in practice, the Directive has had little impact on the patenting of biotechnology.
The European Patent Convention itself excludes as a general matter from patentability inventions
"... the publication or exploitation of which would be contrary to 'ordre publique' or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some of all of the contracting states." 3
The first draft proposal for the Directive did not address matters of morality at all. In response to pressure from the European Parliament, the final form of the Directive contains a general exclusion in similar (although arguably narrower) terms to that contained in the EPC but then goes on to specify certain matters which qualify as being unpatentable including:
" ... processes for cloning human beings,
... processes for modifying the germ line genetic identity of human beings,
... uses of embryos for industrial or commercial purposes and
... 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." 4
In the passage of time between the first and final drafts, the European Patent Office had rendered several decisions on the scope of the morality exclusion. Thus, in the Harvard/Onco-mouse decision 5, a case concerning the patentability of a transgenic non-human mammal, the Technical Board of Appeal stated that the applicability of the exclusion depended on
"a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention?s usefulness to mankind on the other."
Subsequently, in Howard Florey Institute/Relaxin decision 6, a case concerning the patentability of DNA fragments encoding human H2 relaxin, the Technical Board of Appeal held that first, that like all exceptions to patentability, the morality exclusion must be construed narrowly and the function of the exclusion was to ensure that patents would not be granted for inventions which would universally be regarded as outrageous and secondly, that in the circumstances the invention did not involve the patenting of human life.
In the context of the opponents' argument that the patent should not be granted because invention did involve the patenting of human life, the Technical Board of Appeal stated that:
" ... DNA is not 'life' but a chemical substance which carries genetic information and can be used as an intermediate in the production of proteins which may be medically useful."
Plant Variety Rights
Again, the European Patent Convention excludes as a general matter from patentability inventions
" ...in respect of plant or animal varieties or essentially biological processes for the production of plants or animal; this provision does not apply to microbiological processes or the products thereof." 7
Until December of last year, there had been considerable uncertainty as to the scope of this exclusion - was it confined to plant varieties per se or did it extend to cover claims which merely embraced plant varieties.
The Directive adopted the latter position by excluding from patentability plant or animal varieties but also excluding from the exclusion
"inventions concerning plants or animals, the technical feasibility of which is not confined to a particular plant or animal variety." 8
Last December, after the Directive had come into force but before it was meant to have been implemented, in the Novartis II/Transgenic Plant decision9, the Enlarged Board of Appeal adopted the same position as that set out in the Biotechnology Directive i.e., plant claims which cover but do not specifically identify plant varieties are allowable (all other things being equal).
The "Product of Nature" Problem
Again, the EPC provides that discoveries shall not be regarded as inventions for the purpose of patentability. 10
The European Patent Office Guidelines have for a long time set out the principles applicable to the patentability of naturally occurring substances. They state:
"To find a substance freely occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature has first to be isolated from its surroundings and a process for obtaining it is developed that process is patentable. Moreover if the substance can be properly characterised either by its structure by the process by which it is obtained or by other parameters and it is new in the sense of having no previously recognised existence then the substance per se may be patentable. An example of such a case is that of a new substance which is discovered as being produced by a micro-organism." 11
The Directive merely restates both in general terms and with reference to specific examples, the principles set out in the European Patent Convention and the approach advocated by the European Patent Office Guidelines. Thus, it states that:
"An element isolated from the human body or otherwise produced by means of a technical process, including the sequence of 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." 12
In the Howard Florey Institute/Relaxin case13, it was common ground between the parties that until cDNA encoding human H2-relaxin was isolated by the patentee, the existence of this form of relaxin was unknown. The Opponents argument that the subject matter of the patent nevertheless represented a discovery akin to finding a mummified body or new animal in a remote part of the world was rejected wholeheartedly by the Technical Board of Appeal. In so doing, it pointed out that to patent something freely occurring in nature required the claimed invention to be capable of industrial application, new and not obvious. Unlike finding a mummified body or a new animal, the finding of H2-relaxin was capable of industrial application and H2-relaxin itself was novel and also not obvious.
It can be seen from this brief review that in its final form, the Directive does little more than state what is understood to be the current position of the European Patent Office in relation to the exclusions from patentability under the European Patent Convention for immoral inventions, plant and animal varieties and discoveries or products of nature. The debate on these and other issues facing the patenting of biotechnology will therefore continue to be fought out in the European Patent Office and the national courts of the Member States.
First published in Patent World in January 2001.
1 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213/113 30.7.98
2 Diamond v Chakrabarty, 206 USPQ 197
3 Article 53(a)
4 Article 6
5 T19/90  EPOR 501
6 T?/94, OJEPO 1995, 388
7 Article 53(b)
8 Article 4(1) and (2)
9 G1/98 OJEPO 2000, p 112
10 Article 52(2)(b)
11 EPO Guidelines, Part C, Chapter 4, Paragraph 2.3
12 Article 5(2)
13 See ibid