This is an appeal against the refusal of an application by the Examining Division.
Independent claims 1 and 8 to 10 of the main request before the Board read:
1. A method for detecting tumour cells in a living mouse model of human disease, said method comprising:(a) providing a living, mouse comprising tumour cells, said tumour cells comprising a heterologous genetic construct encoding at least one light generating protein;(b) placing the mouse in the detection field of a photodetector device;(c) maintaining the mouse within the detection field of the photodetector device; and(d) measuring through opaque tissue, photon emission from said cells with said photodetector device, to detect said tumour cells.8. A method for identifying a therapeutic compound effective to inhibit the growth and/or metastatic spread of a tumour in a mouse model of human disease, said method comprising:(a) administering tumour cells labeled with or comprising a light-generating moiety to groups of experimental and control living mice;(b) treating the experimental group with a selected compound;(c) localizing the tumour cells in mice from both groups by measuring, through opaque tissue, photon emission from the light-generating moieties associated with the tumour cells with a photodetector device; and(d) identifying the compound as therapeutic if the compound is able to significantly inhibit the growth and/or metastatic spread of the tumour cells in the experimental group relative to the control group.9. A method for identifying a therapeutic compound effective to inhibit the growth and/or metastatic spread of a tumour in a mouse model of human disease, said method comprising:(a) administering eukaryotic tumour cells comprising a heterologous genetic construct encoding a light generating protein to experimental and control groups of living, mice;(b) treating the experimental group with a selected compound;(c) localizing the tumour cells in mice from both groups by measuring, through opaque tissue, photon emission from light-generating proteins associated with the tumour cells with a photodetector device; and(d) identifying the compound as therapeutic if the compound is able to significantly inhibit the growth and/or metastatic spread of the tumour cells in the experimental group relative to the control group.10. A method for identifying a therapeutic compound effective to inhibit the growth and/or metastatic spread of a tumour in a mouse model of human disease, said method comprising:(a) administering eukaryotic tumour cells comprising a heterologous genetic construct encoding a light generating protein to experimental and control groups of living mice;(b) treating the experimental group with a selected compound;(c) measuring photon emission through opaque tissue from mice of both groups with a photodetector device; and(d) identifying the compound as therapeutic if the compound is able to significantly inhibit the growth and/or metastatic spread of the tumour cells in the experimental group relative to the control group.
The question arose whether this request complied with A 53(a):
[13] Independent claim 1 relates to a method for detecting tumour cells in a living mouse model of human disease which includes, inter alia, the step of providing a living mouse comprising tumour cells which comprise a heterologous genetic construct encoding at least one light-generating protein. Dependent claim 6 specifies that the mouse may be a transgenic mouse comprising tumour cells […]. While such a method does not directly embrace the step of introducing the tumour cells into the mice, it presupposes, however, this step. Independent claims 8 to 10 relate to methods for identifying therapeutic compounds which include administering tumour cells to experimental and control groups of living mice. These tumour cells are labelled with or comprise a light-generating moiety or a heterologous genetic construct encoding a light generating protein. Independent claims 8 to 10 also include a monitoring step concerning the growth and/or metastatic spread of the tumour cells in the experimental group relative to the control group.
[14] The board considers that in view of the above-described character of the claimed subject-matter an examination of whether or not the patent exclusion contained in A 53(a) applies is required. The provision stipulates that European patents shall not be granted in respect of inventions the commercial exploitation of which would be contrary to “ordre public” or morality. R 28(d) furthermore specifies that processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal shall not be patented in accordance with A 53(a).
[15] Earlier decision T 315/03 has dealt extensively with the interpretation of A 53(a) and R 23d(d) EPC 1973 (corresponding to R 28(d)) in the context of an invention which concerned the production of transgenic animals having an increased probability of developing neoplasms by the introduction of an activated oncogene sequence into the genome of a rodent. It came inter alia to the following conclusions:
- R 23d(d) EPC 1973 applied to a case which was pending on the date when the rule took effect.
- In cases falling within R 23d(d) EPC 1973, a further or additional objection under A 53(a) 1973 based on the balancing test developed in decision T 19/90 could be raised.
- A case not falling within one of the categories listed in R 23d EPC 1973 had to be considered further under A 53(a) 1973.
[16] The method according to independent claims 8 to 10 include the administration of specifically prepared tumour cells (which may be genetically modified) to living mice and the monitoring of the growth and/or metastatic spread of these tumour cells. The facts of the present case are thus similar to those underlying decision T 315/03, in that the claimed method involves the deliberate generation of tumours in animals. Nevertheless, a substantial difference is that, in contrast to the invention dealt with in decision T 315/03, the methods of claims 8 to 10 do not involve the modification of the genome of the animals themselves. Therefore, the patent prohibition of R 28(d) which concerns processes for modifying the genetic identity of animals cannot be applied directly in respect of the subject-matter of claims 8 to 10.
In respect of this subject-matter the question thus arises whether in the present case the test of R 28(d) should be applied per analogiam and/or whether the balancing test developed in decision T 19/90 and endorsed by decision T 315/03 should be applied under A 53(a). In fact, as explained in more detail in decision T 315/03 [10.5-10], these two tests are not wholly identical. The board considers however that there is no necessity to decide in the present case whether both tests have to be applied cumulatively or which of the two tests has to be applied since both tests lead here to the same result […].
[17] Independent claim 1 of appellant’s request includes the step of providing a living mouse comprising tumour cells which comprise a specific heterologous genetic construct. While the claim does not specify how the mouse which is to be provided was generated, claim 6 which is dependent on it specifies that the mouse may well be a transgenic mouse. It thus appears that certain embodiments of the subject-matter of claim 1 presuppose preceding processes for modifying the genetic identity of animals and therefore have to be assessed under R 28(d). Nevertheless, the test developed in T 19/90 is arguably also of relevance in respect of these embodiments […] and in respect of those embodiments of claim 1 not relating to the provision of transgenic mice […].
[18] Accordingly the board examines whether the subject-matter of the independent claims 1 and 8 to 10 complies with both the tests as laid down in R 28(d) and as developed in decision T 19/90 under A 53(a).
[19] The board is convinced that the deliberate introduction of tumour cells into mice (which is either an explicit step of the claimed methods or is presupposed by them), in particular with the aim of monitoring their growth or metastatic spread, is most likely to cause suffering to these animals. This is in line with the view taken in decision T 315/03 concerning the deliberate introduction of an activated oncogene into the genome of rodents.
[20] The wording of the claims and the description of the patent application make it abundantly clear that the claimed methods are performed in the framework of cancer research. The main purpose is the identification and study of (putative) anti-tumour compounds, thus offering the prospect of a valuable contribution to medical research.
[21] Furthermore, the appellant submitted several documents in order to support its view that the methods of the claimed invention are likely to produce a substantial medical benefit to man or animal.
[21.1] Document D19 is a declaration by Prof. Linda C. Cork, stating that a significant benefit of the optical imaging technology was enabling scientists to observe mechanisms of action or cascading events within the animal. These events would not otherwise be detected using conventional imaging methods. The technology was particularly important in drug studies where biological pathways involving multiple tissues and organs interacted with the drug in a manner that cellular systems or other in vitro systems did not. Prof. Cork expressed the opinion that the developed non-invasive imaging methods could greatly accelerate human medical research, including drug discovery efforts.
[21.2] In document D21, a declaration by Prof. Robert D. Cardiff, it is stated that from the viewpoint of cancer research, the use of in vivo optical imaging in animal studies had been a tremendous biomedical advance. In particular, the use of luciferase as a marker of biological function was a rapid and accessible modality that had already made a significant impact on drug discovery. Since the biological process could be observed within the animals, fewer animals were required for each study with far less suffering during their lifetimes as compared to traditional approaches to animal models of human disease. Any technology that minimized the number and suffering of animals were to be encouraged.
[21.3] In document D22 Prof. Glen Otto declares that the nature of the experiments described in the application was such that the potential medical benefits of the experimentation far outweigh any potential distress caused to the animals. Whereas most drug discovery efforts required death of one or more animals at each time point, the experiments described in the application were non-invasive and allowed sequential data collection from smaller numbers of animals.
[22] In view of the above, the board concludes that the claimed methods of the invention are at least likely to be of substantial medical benefit to man, thus fulfilling the criterion provided for in R 28(d) for escaping the patent exclusion. Likewise, when applying the balancing test as developed in T 19/90, the board considers that this likelihood of substantial medical benefit demonstrates the invention’s usefulness to mankind in human cancer research. The board notes in addition that the appellant’s credible assertion that the claimed methods lead to a reduction of the number of experimental animals in cancer research is a further relevant factor in this balancing exercise.
[23] The board notes lastly that the appellant has restricted the claimed methods to their implementation in mouse models of human diseases, i.e. to conventionally accepted experimental animals. Since the claims do not embrace any other animal, the board considers that they do not cover animals for which the tests provided in R 28(d) and developed by decision T 19/90 might arguably not be complied with. Accordingly, in view of this restriction, the appellant’s arguments previously submitted in order to defend a broader version of the claim requests do not require to be addressed by this board.
[24] The board concludes that the requirements of A 53(a) are met.
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