Andrew Sharples and Duncan Curley, McDermott, Will & Emery, London

Introduction
On 22 June 1984 what was to become one of the most controversial European patent applications on record was filed. When it was granted in 1992, European patent no. 0,169,672 (the ‘Harvard Oncomouse’ patent) initially claimed a method for producing transgenic non-human mammals with a predisposition to developing cancer. The aim behind the invention was to produce laboratory test animals, such as mice, with an increased probability of developing cancer tumours, thereby facilitating study of the disease. The prospect of the commercialisation of animals fated to develop cancer was the cause of significant protest, particularly from certain political and quasi-political groupings vehemently opposed to laboratory testing on animals.

Although the grant of the patent was initially refused, this refusal was overcome on appeal.1 The appeal decision contained two important conclusions. First, it stated that while Article 53(b) of the European Patent Convention (‘the EPC’) excluded animal varieties from patentability, the fact that Article 52(1) stated that patents are available for all inventions capable of industrial application meant that this exception must be construed narrowly. Furthermore, the fact that the words ‘animal varieties’ were used in Article 53(b), rather than merely ‘animals’ or ‘animals as such’, meant that this exclusion did not have the effect of excluding animals per se from patentability. Although the Technical Board of Appeal did not make a ruling on this specific point, it was eventually decided that animals which had been genetically altered did not in themselves constitute animal varieties, and they were not therefore excluded from patentability under Article 53(b).

The other important point to come out of the Technical Board of Appeal’s decision was that the exclusion in the EPC on granting patents for inventions which are contrary to morality or ‘ordre public’ contained in Article 53(a) should, in the case of a claimed invention where the animals were certain to suffer some harm, be assessed by weighing up the suffering of the animals and any possible risk to the environment against the benefits to mankind said to be conferred by the invention. This issue was referred by the Technical Board of Appeal to the Examining Division, which subsequently decided that the benefits of the Oncomouse outweighed the risks, and granted the patent.

Since grant, the patent has spent a decade under opposition from 17 opponents. In 2003, an interlocutory decision was published by the Opposition Division of the EPO. Although the arguments about the ethics of granting a patent with claims to living animal matter have been well rehearsed in the literature, a number of other, technical points related to patentability were put forward in the numerous grounds of opposition.

Patentable Inventions and Discoveries
It was argued that the invention was not patentable because it was a discovery, that is, that it had simply been discovered that mice obtained by the claimed process had increased susceptibility to cancer. The Opposition Division pointed out that if there had been a discovery, the substance or organism must occur in nature. By contrast, transgenic animals were the result of a technical intervention by man and were not therefore a discovery, per Article 52(2)(a) EPC. The claimed invention was not therefore excluded from patentability on this ground.

Additionally, it was argued that the invention was excluded from patentability because the mice were created by chromosomal incorporation of an oncogene, which was a surgical process and therefore unpatentable under Article 52(4) EPC. The patent proprietor argued that the exclusion from patentability of surgical processes in the EPC actually related to treatment of the animal body, and this was distinct from a living cell, on which the actual chromosomal incorporation was performed in the claimed invention. The Opposition Division agreed, stating that a distinction must be made between living cells and whole organisms, and the incorporation of the oncogene in mice was a process that was not surgical, therapeutic or diagnostic in nature.

Novelty and Inventive Step
The opponents focused particularly on an article published by Brinster et al. in Cell in June 1984. As the priority date of the patent was 22 June 1984, the assumption had been made by unable to provide any evidence in support of an earlier publication date for the Brinster publication, the Opposition Division proceeded on the basis that the article was published on, or later than, the priority date. Consequently, it was not relevant for consideration of novelty, and as there were no other prior art documents containing disclosures that were even close to the subject-matter of the patent, the arguments concerned with lack of novelty failed.

The Brinster article was of course also irrelevant when lack of inventive step arguments were considered. However, an argument was put forward that there was no inventive step over the common general knowledge, since (it was said) all the invention did was to introduce a known gene linked to a known promoter into mice in a known manner. The patent proprietor argued that, at most, this only made it obvious to try the method of the invention, but that the viability of the animals was not at all predictable and there was no reasonable expectation of success. The Opposition Division agreed, citing an item of prior art which showed that mice carrying oncogenes did not necessarily develop tumours. The technical problem of the invention was providing animals which had increased susceptibility to cancer. There was no reasonable expectation of success with this endeavour, based on the common general knowledge. Thus, the invention was not obvious over the common general knowledge.

Industrial Application
Three arguments were made based on alleged lack of industrial application of the invention. First, it was said that because the oncomice had turned out to be a commercial failure, they were not industrially applicable. Additionally, the success rate of 1 to 3 per cent was not sufficiently high for commercialisation. Finally, no industrial application was shown for any animal other than mice: no industrial application had been shown in relation to animals such as giraffes, elephants or blue whales.

The proprietor pointed out that industrial application did not require commercial success. The inventive concept applied to the invention as a whole, and not to every specific embodiment of it. The Opposition Division agreed both that commercialisation was irrelevant in considerations of patent law and that industrial application need not be demonstrated for every embodiment. Given that the nature of the invention was the provision of test animals for cancer, references to elephants, giraffes and blue whales were inappropriate.

Sufficiency of Disclosure
This had been examined at length in the appeal against the initial refusal, carried out by the Technical Board of Appeal. Nevertheless, it was reprised before the Opposition Division, the proprietor relying substantially on the previous decision. The Opposition Division pointed out that the Board of Appeal ruling was not binding upon them, but despite this, they agreed with the ratio of the Technical Board’s decision and rejected this ground of opposition.

Patentability of Animals
By the time of the Opposition Division’s decision, arguments to the effect that animal life must be excluded from patentability as a matter of principle had been superseded by both the implementation of rules 23b to 23e to the EPC (which incorporate aspects of European Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, which specifically states that animals are patentable subject-matter, provided the patent is not confined to a specific animal variety) and by the decision of the Enlarged Board of Appeal in Decision G1/98 (the Novartis decision, which addressed a similar point in relation to plant varieties).

Although rules 23b to 23e post-dated the filing of the oppositions, having been inserted by a decision of the Administrative Council of the EPO of 16 June 1999 (and entering into force on 1 September 1999), absence of transitional provisions meant that these rules did in fact apply. In any event, the Opposition Division pointed out that these rules were not a departure from, but merely an interpretation of, the previous law. They had not changed the law, but merely set out a situation which would have fallen within the law as at the date of filing of the oppositions. Consequently, on considering these rules and the only applicable case law,2 the Opposition Division drew a number of conclusions.

It was emphasised that living matter, in particular plants and animals, can be the subject of patent protection. Applying the logic of the Novartis decision to animals, it was decided that groupings of animals characterised by a specific gene do not fall within the exclusion from patentability of animal varieties in the EPC. The Opposition Division had no doubt that the invention as claimed applied to more than just varieties of mice, and the invention at hand was not excluded from patentability because of the bar in the EPC on the patenting of animal varieties.

Morality and Ordre Public
Arguments based on morality and ordre public essentially underpinned all of the opposition briefs, with every opponent taking the view that either the nature of the invention or the nature of the proprietary interest being granted over living matter, or both, were inherently morally offensive. A range of arguments were advanced. Some argued that animals in general should not be patented, some argued that the weighing up of benefit to mankind against the suffering of animals had not been done properly, and that the limited value of the invention and modest gain from using the Oncomouse meant that this did not outweigh the suffering to be imposed on the animals by means of the invention. Other opponents argued that the ‘weighing’ approach was wrong in principle, being unsuited to assessing the morality of any particular invention, and that instead an assessment should be made of whether an invention was inherently immoral, morality not being achieved simply by the ends justifying the means. It was also contended that the patenting of animals was inconsistent with religious and modern secular beliefs. It was argued that the majority opinion should be decisive, and as such, a number of opinion polls were submitted in support of the opponents’ position. Finally, it was stated that a sui generis form of protection was far more appropriate for animal technology, and that even though there was no such system in place, this did not mean that per se patent protection of animals was appropriate.

The proprietor responded with its arguments, which were that in assessing morality, the views of patient groups were at least as relevant as other sections of society. The proprietor also showed that many non-transgenic rodents had been selectively bred to be susceptible to cancer, and consequently, this invention did not provide for something fundamentally morally different from what was already available. The proprietor also pointed out that animal testing was a requirement in all of the EPC contracting states, regardless of suffering. Finally, it was argued that the standard for morality must not be based on extreme views.

The Opposition Division set out several underlying principles for approaching issues of morality and ordre public in assessing patentability:

* Issues of morality and ordre public would only arise in exceptional cases (although this case was arguably such an instance);

* Rule 23c(b) points out that animals are patentable, and so arguments to the effect that patents claiming animal matter are inherently immoral must fail;

* Extreme positions will not be taken into account (for example, possible abuses of the invention or a complete disregard for issues of ordre public and morality);

* The balancing test of Decision T19/90 has now been superseded by rule 23d(d). However, the approach is similar. Rule 23d(d) requires that patents shall not be granted for processes (and the resultant animals) modifying the genetic identity of animals which are likely to cause the animal suffering, without there being any substantial medical benefit to man or animal;

* Assessments of ordre public and morality should be made by looking at the rules and regulations common to most of the EPC contracting states, since these would be the best indicators of morality within the relevant societies. Insofar as such laws exist, there is no need to rely on other forms of assessment (such as opinion polls).

In applying these criteria, the Opposition Division relied on existing European laws governing the use of animals and medical research. Given that such use is generally allowed (albeit subject to certain conditions), and because the animals of the invention would be useful as test animals, the patent was held to comply with the requirement for morality.

That still left the date for assessment under rule 23d(d). It was held that this assessment must be made at the priority date of the patent application. While in this case there was obvious suffering to the animals, assessing the probable benefit at the effective date of the patent (without taking into account later evidence as to the actual outcome of the exploitation), there was a definite prospect of a substantial medical benefit. Therefore rule 23d(d) was satisfied.

The Opposition Division posed the question as to how one should assess where there is suffering, and whether there is substantial medical benefit. However, other than setting the date of the assessment, no general principles were given as to how these assessments should be carried out.

Although they had been defeated on all of the substantive grounds of opposition, there was some comfort for the opponents. The assessment of medical benefit applied only insofar as the subject-matter of the invention was capable of being embodied in test animals. Consequently, the fact that the claims as drafted were directed to non-human mammalian animals fell foul of this criterion, because the claims additionally covered many other inappropriate animals. The Opposition Division therefore rejected the initial claims of the patent, but accepted amended claims limited by the proprietor solely to rodents. In conclusion, the patent (as amended) was held valid by the Opposition Division.

Conclusion

This was an interlocutory decision. These are usually issued by the EPO in order to provide guidance and to save the time and cost of further proceedings. However, given that this decision has now been appealed, whether it will in fact serve to shorten or to lengthen the proceedings remains an open question.

While the decision does not alter the law concerning the patentability of animals (indeed, it reiterates the previous case law and established statutory principles), the Guidelines set out by the Opposition Division relating to the assessment of morality may have somewhat wider application in other areas of biotechnology. In particular, the fact that the Opposition Division has now expressly stated that morality will be assessed by reference to the laws of Member States, and that other factors will only be considered when such laws do not exist, would seem to give support to the view that patent law is not an appropriate forum for regulating controversial technologies such as genetic engineering. The Opposition Division has highlighted the importance of relying on national governments to decide what is and is not acceptable within society, rather than the EPO. That at least must be democratically and perhaps even morally correct.

1) Decision T19/90.

2) Decisions G1/98 and T19/90.

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