Patentability of Animals

Industrially useful inventions are generally patentable if they are novel and involve an inventive step (i.e. they are surprisingly different, rather than simply a routine development, modification or combination of previously known features). Biotechnology is providing the capability to produce novel genetically modified organisms (plants, microorganisms and animals) which are commercially valuable and industrially useful. Patent protection for these innovations is being sought in many countries.

When a patent is granted, the monopoly right given by the patent is defined in patent claims which must be supported by a detailed description with one or more examples of how the invention can be carried out and used. The description may describe variations on the basic inventive concept covering a number of ways in which the invention can be put into practice.

The grant of a patent confers only a civil right on the patent owner to prevent others doing what is claimed in the patent. It does not give the owner any specific rights to exploit the invention himself. He might be prevented from exploiting the invention by virtue of a patent right held by a third party, or he might be prevented by reason of law or regulation. For example, an inventor might successfully obtain a patent for a particularly unusual construction of a rocket-propelled motorcycle, but in order to use it he would have to satisfy other laws and regulations relating to the control of road vehicles. If such vehicles were completely forbidden for use on roads it would nonetheless not prevent him from experimenting with them, obtaining patents for them and testing them under controlled conditions. If the invention was commercially valuable but no patent protection was available that might not, of itself, stop him from developing the technology but it might deter others from investing money in any business set up to exploit the technology of the invention. There would be no incentive to put the effort into development and commercialisation if competitors could copy the finally developed idea. These same considerations apply, particularly with respect to regulation and control, in the field of patenting biotechnology.

By specific provisions of the UK and European patent laws it is not possible to have a valid patent claim which claims an essentially biological process as such (e.g. a method comprising mating a bull from one cattle breed with a cow from another cattle breed to produce a cross-bred calf). Nor is it possible to have a valid patent claim with scope so narrow as to cover only a group of animals comprising an "animal variety" as such. An "animal variety" is not legally defined in European patent law, but may be taken to be a group of animals of the same species which have been selected to constitute a breed having at least one significant and identifiable characteristic. The meaning of the term "breed" is well defined and understood within the farming industry. Patents should not be granted for inventions which are judged morally offensive or against the “ordre public”. There is no absolute criterion of moral offensiveness: the decision rests with the Patent Offices and Courts in each country and, ultimately, with public opinion.

Recent advances in animal husbandry and biotechnology mean that new organisms can be bred which differ from previous organisms of the same type by virtue of a modification caused by human technical intervention. Hence the production of genetically modified organisms, whilst possibly being for the most part an essentially biological process, may now involve a critical process step which is essentially non-biological (e.g. the insertion of a segment of a foreign gene into the animal's DNA). Such processes (being a combination of essentially biological steps in combination with other steps) taken as a whole fall outside the specific exclusion clauses and are therefore patentable provided they meet all other requirements for patentability. Furthermore, the new techniques and the new products for which patent protection is sought are generally applicable or obtainable over a whole range of species or even genera. The inventor of a useful and advantageous modification should in principle be able to obtain patent claims of broad scope which would cover any animal from a broadly defined group (larger than a breed or variety) within which all group members embody the invention. Claims to such a group fall outside the specific exclusion of claims to animal varieties.

In Europe, the Biotechnology Directive 98/44/EEC (approved by the European Parliament in May 1998) allows the patenting of animals (subject to certain conditions). The test case in Europe is “The Harvard Mouse” or “oncomouse” patent application filed on 24 June 1985. The inventors devised a technique for inserting a gene which increases sensitivity to cancer (an oncogene) into the DNA of animal cells and this enabled the inventors to clone laboratory test animals (generally mice) which are useful for testing and identifying any potential cancer-causing chemicals. After long and detailed examination by the EPO Examining Division and Board of Appeal, the case granted on 13 May 1992 (Ref: EP Application No. 85304490.7, Publication No. 0 169 672B). The granted patent included claims to the technique and also to non-human animals produced by the technique. In allowing the case, the EPO considered both the technical questions of patentability and the numerous ethical questions raised by many third party objectors.
However, the matter was not closed because there was opportunity for objectors to oppose the grant of the patent by the EPO. Oppositions were indeed lodged by a number of objectors including a coalition of animal welfare groups. All of the oppositions were lodged on ethical/moral principles (not on technical grounds). A final hearing was held in November 2001, and a decision from the Opposition Division of the EPO issued on 16 January 2003. The Opposition Division decided to maintain the granted patent, with the claims restricted in scope to cover the invention carried out in rodents only (rather than any non-human animal as per the originally granted claims). The patent claims upheld by the Opposition Division covered methods of making transgenic rodents and transgenic rodents per se, as well as directly related plasmids, chromosomes, cells, methods of culturing transgenic rodent cells, and methods of testing for carcinogenic materials.

Several of the opposing parties filed Appeals in March 2003 against the Opposition Division’s decision (Appeal Reference EPO T0315/03). At Oral Proceedings on 5-6 July 2004, the Appeal Board decided to uphold the patent in a further restricted form in which the term “rodent” was limited to “mouse”. Reasons for the Appeal Board decision were published by the EPO in March 2005. The Appeal Board considered two key issues in detail: (i) whether in the present case the process for modifying the genetic identity of the animals would be likely to cause the animals suffering without any substantial medical benefit to man or animal; and (ii) whether the publication or exploitation of claimed invention would be contrary to “ordre public” or morality. The Appeal Board held that they could see no medical benefit in relation to rodents as a group (including species such as squirrels) but that the invention when limited to mice was shown to have substantial medical benefit. The contrasting positions put forward on the issue of morality reflected divergent European perspectives, but the Appeal Board held that the usefulness of invention to mankind was sufficient to outweigh the evidence before it against “ordre public” or morality. By the time the Appeal Board’s final decision was published, the upheld “Harvard Mouse” patent was only a few months away from its 20 year patent expiry term. However, the oncomouse test case has confirmed that in principle it is possible at present to obtain a European patent for a non-human animal produced by genetic modification.      

Both the US and Japan have already recognised the patentability of animals.

In contrast, the corresponding “Harvard Mouse” case in Canada has been held to be unpatentable because Canadian patent law excludes higher life forms.

Conclusion

Man has always owned and exploited animals for his own purposes both as pets and as livestock. Animals are goods of trade and fall within the definition of "goods" in the UK Sale of Goods Act 1975. The genetic modification of domestic animals has been carried out to-date by traditional breeding methods and selection. Legislation exists in the UK and Europe to control genetic experimentation (such as Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes), and to control the introduction of genetically modified organisms into the environment (such as Directive 90/219/EEC and Directive 90/220/EEC regarding the contained use and deliberate release into the environment of genetically modified organisms). The general public must be reassured and have confidence that the necessary rules and safeguards are in place and effectively enforced. In the UK, genetic experimentation is strictly controlled by the Health and Safety Executive. So long as innovative research and development in the field of biotechnology continues to be accepted as part of technological progress, results of such efforts should be protectable by intellectual property rights, provided that the criteria for patentability are met. European patent law now provides certain additional criteria for assessing whether or not a process for genetically modifying animals, or animals produced by such processes, are patentable, for example by imposing a test which weighs up the likelihood of suffering by the animal against any substantial medical benefit to man or animal.

April 2008 (originally prepared August 1993)