Three recent decisions in the European Patent Office have contributed to the developing law on the patentability of inventions involving genetic engineering. The first two (one by an opposition division and the other by an appeal board address the issue of the EPO's prohibition on inventions that are contrary to morality, the appeal board decision also addressing the issue of the EPO's prohibition on the patentability of "plant varieties". The third decision, also by an appeal board addressed the standards to be applied in assessing obviousness in genetic engineering cases.

In the case of Howard Floney Institute/Relaxin, the EPO had granted a patent in which claim 1 read as follows: "A DNA fragment encoding human H2-preprorelaxin, said H2-preprorelaxin having the amino acid sequence set out in Figure 2". The patent was opposed by the Green Party of the European Parliament on the ground that what was claimed was a discovery rather than an invention and that the grant of a patent for a human gene offends morality or ordre public.

Evidence showed that genomic DNA coding for H2-preprorelaxin contained introns which caused the natural material to contain additional amino acids that were not present in the amino acid sequence set out in Figure 2. The Opposition Division, however, indicated that it would not base its decision on this difference and that its decision would be the same "even if genomic DNA sequences encoding human relaxin were included in the scope of the claims". Since evidence showed that prior to the invention the existence of the form of relaxin specified in the claim was unknown, and as EPO guidelines permit novelty to be recognized for a natural substance which has been isolated for the first time if it had no previously recognized existence, the Opposition Division concluded that the claim had novelty. The Opposition Division also dismissed arguments that the "invention" claimed was really a mere "discovery" as being incompatible with long standing EPO practice in respect of the patentability of other natural substances as set out in the guidelines.

On the question of morality the opponents submitted three major arguments:

On the first ground, the Opposition Division concluded that, as long as the subject from whom human tissue was taken consented to the taking of that tissue, there was nothing immoral in the mere act of taking tissue since this is a standard practice in medical procedures.

So far as the "slavery" argument is concerned, the Opposition Division concluded that the opponents' arguments "betray a fundamental misunderstanding of the effects of a patent". Since patents relating to human genes do not confer on their proprietors any rights whatsoever to individual human beings no question of slavery arose. On the final argument that the patenting of human genes was immoral since it was tantamount to patenting life, the Opposition Division's position was that all that was being claimed was a particular chemical substance and that

The Opposition Division noted that the opponents did not object to patenting and exploitation of other human substances for medical purposes and could see "no moral distinction" between "the patenting of genes on the one hand and of other human substances on the other especially in view of the fact that only through gene cloning have many important human proteins become available in sufficient amounts to be medically applied". In support of its conclusion that the patenting of human genes was not so clearly abhorrent to everyone that it should be regarded as immoral, the Opposition Division also referred to the situation in the EU where, as noted in our April 1995 Newsletter, a proposal for a directive on protection of biotechnology inventions failed to be adopted, in view of a lack of agreement between the European Parliament, which opposed the granting of patents on human genes, and the Council of Ministers, which in principle was in favor of granting patents on isolated human gene DNA fragments. Thus, a suggestion by the opponents that there should be a moratorium on the grant of patents in this field until the EU situation was resolved would be inappropriate and, according to the decision "moreover impossible because there is no legal mechanism in the EPC [European Patent Convention] for doing so".

Finally, the Opposition Division noted that exceptions to the grant of patents for inventions because they were "immoral" should only occur "in those very limited cases in which there appears to be an overwhelming consensus that the exploitation or publication of an invention would be immoral". Clearly, in the present case there was no such overwhelming consensus and the grant of the patent should be upheld.

It is understood that the case will be considered further on appeal.

The question of morality was considered by an appeal board in a case relating to the patentability of genetically engineered plants (plant cells/plant genetic systems). The board held that "inventions, the exploitation of which is not in conformity with the conventionally accepted standards of conduct pertaining to [the culture inherent in European society and civilization] are to be excluded from patentability as being contrary to morality".

The opponents submitted evidence from a survey of farmers in Sweden and a Swiss public opinion poll in support of the contention that the grant of patents for plants would be immoral or contrary to ordre public (another ground for rejecting Europe patents). The board was not convinced noting that "the results of surveys and opinion polls can fluctuate in an unforeseen manner within short time periods." Furthermore the board could see no moral distinction between modifying plant characteristics by genetic engineering and by traditional selective breeding. Genetic engineering simply made the modifications punctual and increased the number of modifications possible. In certain cases there might be a misuse or destructive use of this potential that would render an invention unpatentable as contrary to ordre public or morality. However, the production of herbicide resistant plants did not fall into this category, notwithstanding the fact that there was the possibility of undesired side effects (for example transfer of the herbicide resistant gene to weeds) that might result in damage to the environment.

The Board did, however, reconsider earlier case law on a further prohibition in the European Patent convention, namely that on the grant of patents for "plant varieties". Earlier case law had concluded that this provision applied only if what was being claimed corresponded with something that was protectable under the International Convention for Protection of Plant Varieties (UPOV - which contains certain restrictive criteria on what may be protected under its auspices). The Board now felt that this interpretation was not entirely logical since it permitted claims covering several different varieties but excluded claims covering several different varieties but excluded claims restricted to a single variety. It now adopted as the appropriate definition "any plant grouping within a single botanical taxon of the lowest rank which is characterized by at least one single transmissible characteristic distinguishing it from other plant groupings and which is sufficiently homogeneous and stable in its relevant characteristics," irrespective of whether the plant would be eligible for protection under UPOV. Consequently plant per se claims were held to be unpatentable in the present case although claims to plant cell cultures were permissible.

The third case, that of Expression in yeast/Genenetech involved the appeal in a ten party opposition to a patent on an "empty" vector that was "read to use" to insert exogenous genes into yeast by reciting as the essential feature of the vector the various DNA components that would be necessary to incorporate the vector into a yeast's genome and have any gene included in the vector function in a yeast cell. It thus aimed to cover a basic tool in application of genetic engineering techniques to yeast. The board addressed the issue of obviousness at some length. The Board accepted that in the field of genetic engineering the skilled worker would adopt a conservative attitude to what he or she would expect to work. The relevant test is not whether the skilled person "could" have tried to modify what was taught in the prior art but rather in the light of the cautious attitude of the industry he or she "would" have done so. In the present case, however, the technique involved were known from the adjacent neighboring art, namely genetic engineering in bacteria. The patentee argued that in so far as some of its claims were concerned (which involved delection of some of the DNA in the region containing the promoter) "the skilled person would not have taken the incalculable risk of carrying out any genetic engineering in that region because little was known about its possible influence on expression in yeast". The Board disagreed noting that sufficient was known in respect of mutant yeasts where changes had occurred in the reason in question for the skilled worker to regard changes in this region as "feasible". Thus, to quote the official headnote:

What was claimed was, therefore, obvious to try with reasonable expectations of success and hence was not patentable.