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Chemical and Biochemical Practice at the EPO

Biological Inventions at the EPO

Article 53(b) of the European Patent Convention provides that patents shall not be granted for "plant or animal varieties or essentially biological processes for the production of plants or animals." The article goes on to state, "this provision does not apply to microbiological processes or the products thereof." The Convention also requires that patents shall not be granted on inventions whose exploitation would be contrary to morality or ordre public.

The morality issue first came before the EPO in the case of the Harvard Oncomouse and is still there. The Examining Division, after being told by the Board of Appeal that there was no absolute prohibition of the patenting of animals but only of animal varieties[1], issued a decision to grant a patent for the invention.

On the question of the morality and public order, the Examining Division believed that a balancing test was appropriate in every case depending on the invention in question. In the present case three factors need to be considered:

1) the interest of mankind in providing remedies for dangerous diseases

2) protection against uncontrolled dissemination of unwanted genes

3) prevention of cruelty to animals.

Because in the present case the invention opened the way to needing fewer animals for experimentation, and the invention could be practiced in a way that avoided widespread dissemination of genes, the Division concluded that the advantage of providing a tool for use in the fight against cancer outweighed the possible negative factors. Thus the invention was patentable.

Following the grant of the European patent, it was opposed and the opposition is still pending. After a noisy opposition hearing in a public hall specially hired for the purpose in November 1995, the proceedings were adjourned to be continued in writing. All submissions were due to have been filed by February 1997. So far, however, there has been no decision.

The morality question came up again in connection with the patentability of genes in Relaxin/Howard Florey Research Institute.[2] In this case 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:

1) that in order to put the invention into practice one had to take tissue from a pregnant woman and this constituted "an offense against human dignity";

2) the patenting of human genes "amounts to a form of modern slavery since it involves the dismemberment of women and their piecemeal sale to commercial enterprises"; and

3) the patenting of human genes is inherently immoral.

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 patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned (and possibly patented) it would be impossible to reconstitute a human being from the sum of its genes".

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 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.

No such issues of morality came up in the Lubrizol case on the question of the patentability of claims to a process for rapidly developing hybrids and commercially producing hybrid seeds, hybrid seeds themselves and phenotypically uniform plants obtained from such seeds.[3] Although the steps required in the process claim were only crossing and cloning steps, it was held that the special sequence meant that the process ceased to be "essentially biological," thus it was patentable.

So far as the plant claims were concerned, the Board first had to determine what was meant by the term "variety." It found that there was no generally accepted meaning. The Board concluded that a "variety" meant "a multiplicity of plants which are largely the same in their characteristics and remain the same within specific tolerances after every propagation on every propagation cycle." The Board concluded that plants obtained by the invention lacked sufficient stability to be a variety. Thus they did not fall within the prohibition or protection of plant varieties.

A subsequent case involving plants differed in its conclusions. In Plant cells/Plant Genetic Systems[4] the morality issue and also that of ordre public were raised. It was 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. 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. If, however, it could be shown that exploitation of an invention would "seriously prejudice the environment", a rejection on the ground that the invention was contrary to ordre public might be appropriate.

The Board went on to reconsider the Lubrizol decision on the meaning of the prohibition on the grant of patents for "plant varieties" discussed above. The Board now felt that this interpretation was not entirely logical, since it permitted 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.

Since this view seems in conflict with that of the Oncomouse case, the question of the patentability of claims to plants and animals was referred to the Enlarged Board of Appeals by the President of the EPO under a procedure permitting the president to refer issues where there seems to be a conflict between different Appeal Board decisions for consideration of the general question. Unfortunately, the Enlarged Board ducked the issue and held that there was no conflict between the decisions because the Oncomouse case had merely decided that it was possible that some types of animal claim were patentable and that the Plant genetic systems case had really decided that what was being claimed was in fact a new transgenic plant variety.[5]

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© Copyright 1997 John Richards - Posted 11/29/97 v4
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