DECISIONS OF THE EXAMINING AND OPPOSITION DIVISIONS
Grant of European patent No. 0 169 672 (Onco-mouse/Harvard)
I. Introduction
On 24 June 1985, Harvard College applied to patent a process for producing genetically manipulated animals, plus a transgenic animal itself. The application was refused by the Examining Division on 14 July 19891, on the grounds that the EPC did not permit the patenting of animals per se.
On appeal, the case was remitted to the Examining Division by Technical Board of Appeal 3.3.2 (T 19/90 of 3 October 1990)2, which found that the EPC ruled out patents only for certain categories of animals, not for animals as such. However, the Board added that the Division should also consider whether the invention was contrary to public order and morality within the meaning of Article 53(a) EPC. In particular, the suffering inflicted on the animals, and the possible risks to the environment, had to be weighed against the invention's usefulness to humanity.
After carefully re-examining the application in the light of the Board's ruling, the Examining Division on 4 October 1991 issued the communication under Rule 51(4) EPC indicating that it intended to grant a patent. In view of the case's particular importance, it also took the unusual step of commenting in writing on the fundamental patentability issues involved. The decision to grant dated 3 April 1992 took effect on 13 May 1992 when mentioned in the European Patent Bulletin.
The patent will be carefully scrutinised further during the opposition and appeal proceedings which can now be expected. A final decision on the "onco-mouse" is therefore likely to take several years yet.
II. Decision of the Examining Division dated 3 April 1992 (Onco-mouse/Harvard)
(Official Text)
Applicant: President and Fellows of Harvard College
Headword: Onco-mouse/Harvard
Keyword: "Patentability of animals - animal and animal variety - ordre public and morality" - "Rights conferred by a patent"
Headnote
1. Mammals and rodents constitute a taxonomic classification unithigher than "animal variety", "race animale", "Tierart" in Article 53(b) EPC and are therefore not excluded under this provision from patentability.
2. Article 52(1) EPC contains a general principle of patentability, which can only be denied where other legal provisions exclude certain subject-matter from the access to a patent.
3. With respect to the requirements of Article 53(a) EPC, for each individual invention the question of morality has to be examined and possible detrimental effects and risks have to be weighed and balanced against the merits and advantages aimed at.
4. A patent does not give a positive right to use the invention but rather the right to exclude others from doing so during a limited period of time. It is up to the legislator to enact appropriate provisions on the conditions under which certain technical knowledge involving dangerous materials may be used.
Order
Following examination of application No. 85 304 490.7 (Publication No. 0 169 672) a European patent is hereby granted according to Article 97(2) EPC, in respect of the designated Contracting States.
Comments on the decision to grant attached to the Rule 51(4) EPC notification
(1) In its Decision T 19/90 (OJ EPO 1990, 476) the Board of Appeal remitted the present application to the Examining Division. The Board decided that the rejection of the application by the Examining Division on the grounds of Article 53(b) EPC (non-patentable subject-matter) and Article 83 EPC (insufficiency of disclosure) was not justified. To this extent the Division is bound by the determining reasons for the decision (ratio decidendi - Article 111(2) EPC).
The Board ordered the Examining Division to consider in the further examination whether the subject-matter of the present application constitutes an "animal variety", "race animale" or "Tierart" within the meaning of Article 53(b) EPC and concluded on this point as follows: If the Division comes to the conclusion that the subject-matter is not covered by any of these three terms, then Article 53(b) EPC constitutes no bar to patentability.
Furthermore, the Board ordered the Division to consider whether Article 53(a) EPC is a bar to patenting the present invention and according to the Board this would seem to depend mainly 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.
In view of the extraordinary attention the present case has attracted from the public and the importance the public attaches to the question of patenting animals in the light of public order and morality, exceptionally in a granting procedure the Examining Division considers it appropriate to make a statement on its position concerning these questions.
(2) The only claims in the present patent application which are directed to animals are generically drafted claims to non-human "mammals" and to "rodents". Accordingly, the question to be answered is whether or not the subject-matter of these claims is covered by the term "animal variety" or its counterparts in the other two official languages as referred to above. Although the term "animal variety" is not entirely clear, in particular in view of the differing wording in the three equally binding languages of the EPC, it nevertheless can be stated with certainty that rodents or even mammals constitute a taxonomic classification unit much higher than species ("Tierart"). An "animal variety" or "race animale" is a sub-unit of a species and therefore of even lower ranking than a species. Accordingly, the subject-matter of the claims to animals per se is considered not to be covered by the above three terms of Article 53(b) EPC.
(3) In considering whether the claimed invention is contrary to ordre public or morality the following principles of patent law are to be noted:
- A patent does not give a positive right to its proprietor to use the invention but rather only confers the right to exclude others from using the invention for a limited period of time. If the legislator is of the opinion that certain technical knowledge should be used under limited conditions only it is up to him to enact appropriate legislation.
- Article 52(1) EPC contains a general principle of patentability which can only be denied if other provisions in the law exclude certain subject-matter from the access to a patent. Such exclusions are to be interpreted narrowly.
- The development of new technologies is normally afflicted with new risks; this is an experience mankind has made many times in the past. The experience has also shown that these risks should not generally lead to a negative attitude vis-à-vis new technologies but rather to a careful weighing up of the risks on the one hand and the positive aspects on the other and that the result of this consideration should be the determining factor in whether a new technology should be used or not. If higher life forms are involved in the new technology it is not only the risk which must be considered but also the possible harm which is done to such higher life forms. This leads one to the question of morality. Inventions which are made in connection with a new technology and which are to be patented under the EPC have to satisfy the requirements of Article 53(a) EPC. This means that for each individual invention the question of morality has to be examined and possible detrimental effects and risks have to be weighed and balanced against the merits and advantages aimed at.
- From the previous items it follows that biotechnological inventions and particularly inventions relating to genetic engineering are not in general excluded from patent protection.
(4) In the case at hand three different interests are involved and require balancing: there is a basic interest of mankind to remedy widespread and dangerous diseases, on the other hand the environment has to be protected against the uncontrolled dissemination of unwanted genes and, moreover, cruelty to animals has to be avoided. The latter two aspects may well justify regarding an invention as immoral and therefore unacceptable unless the advantages, i.e. the benefit to mankind, outweigh the negative aspects. The following considerations particularly apply:
(i) The present invention's usefulness to mankind cannot be denied. Cancer is one of the most frequent causes of death in many countries of the world and also causes severe suffering. Any contribution to the development of new and improved human anti-cancer treatments is therefore a benefit to mankind and must be regarded as valuable and highly welcome by everybody. Legislation in Contracting States allows animal testing under certain restrictions and subject to administrative approval.
(ii) The Applicant has pointed out that the use of the animals according to the invention gives rise to a smaller number of animals being required when compared to the number of animals needed in corresponding conventional testing. Accordingly, the present invention contributes to a reduction of the overall extent of animal sufferìng.
(iii) Another question to be considered in this connection is whether there exist alternatives to animal testing in the given context which are as reliable as the animal tests and which are therefore accepted by health authorities. In this respect it is noteworthy to take into account what the scientific community thinks about animal testing procedures in cancer research and this is well reflected in an overview article by A. Berns in Current Biology, Volume 1, Number 1, 1991, p. 28, who concludes that onco-mice are a powerful tool with which co-operating genes in tumorigenesis can be identified.
Thus it is clear that in cancer research animal test models are at present considered indispensable.
(iv) In respect of "possible risks to the environment" the Division has considered the purpose of the present invention and the risk which may be associated by practising the invention in the purpose-limited way. Obviously, the purpose of the present invention is to provide animal test models which are to be used exclusively in the laboratory under controlled conditions by qualified staff. No release is intended into the general environment. Therefore the risk of an uncontrolled release is practically limited to intentional misuse or blatant ignorance on the part of the laboratory personnel carrying out the tests. The mere fact that such uncontrollable acts are conceivable cannot be a major determinant for deciding whether a patent should be granted or not.
Exclusion from patentability cannot be justified merely because a technology is dangerous. There are many examples of inventions the patentability of which has never been questioned which cannot be used without severe security measures. For example work with certain pathogens is allowed under very limited conditions only and release of the material into the environment must be excluded by appropriate measures; patentable inventions may nevertheless arise from such work.
The regulation of the handling of dangerous material is not the task of the European Patent Office but is rather the business of specialised governmental authorities.
(v) In the overall balance the Examining Division concludes that the present invention cannot be considered immoral or contrary to public order. The provision of a type of test animal useful in cancer research and giving rise to a reduction in the amount of testing on animals together with a low risk connected with the handling of the animals by qualified staff can generally be regarded as beneficial to mankind. A patent should therefore not be denied for the present invention on the grounds of Article 53(a) EPC.
(vi) It should be stressed that the above considerations apply solely to the present case and that other cases of transgenic animals are conceivable for which a different conclusion might be reached in applying Article 53(a) EPC.