Bioethics and Patent Law: The Case of the Oncomouse
The Oncomouse, genetically modified to develop cancer for the purposes of medical research, raised complex ethical issues for patent authorities. (Credit: Photo by Harvard Medical School, © Harvard College)
This article is the second in an occasional series which highlights issues that have arisen in some significant patent law cases concerning biotechnology and bioethics. Here we look at how several jurisdictions have dealt with the ethical implications of patenting transgenic animals.
Animals are called "transgenic" when DNA from other species has been artificially introduced into their genome. Transgenic animals have been developed for potentially beneficial applications, such as medical research, enhanced food production, and the production of proteins or organs. But the genetic manipulation of animals, particularly mammals, also raises a host of ethical issues that can be highly controversial.
Such issues are much wider than the questions relating to patentability. And governments may of course at any stage of research and development directly outlaw any technology deemed inherently unacceptable. But it is notable that some controversial new technologies only surface publicly when they reach the patent office.
So what has happened when inventors have sought to patent transgenic animals?
Among the first transgenic animals to be produced was the oncomouse. Researchers at Harvard Medical School in the early 1980s produced a genetically modified mouse that was highly susceptible to cancer, by introducing an oncogene that can trigger the growth of tumors. The oncomouse (from the Greek word for tumor) was conceived as a valuable means of furthering cancer research. Harvard College sought patent protection in the United States and several other countries.
The case raised general ethical issues regarding transgenic technology in itself. But it also raised two key issues for the patent system:
- should patents be granted at all for animals or animal varieties, particularly for higher-order animals such as mammals, even if they do otherwise meet patentablility criteria (novelty, industrial applicability/usefulness, inventive step etc.)?
- how should moral implications be addressed in relation to specific cases, e.g. the question of suffering caused to the transgenic animal?
These issues have been resolved differently by the patent authorities of different countries, as the following examples illustrate.
United States - patent granted
The United States Patent Office in 1988 granted a patent no. 4,736,866 to Harvard College claiming "a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…" The claim explicitly excluded humans, apparently reflecting moral and legal concerns about patents on human beings, and about modification of the human genome.
EPO - applying the utilitarian test
Researcher studying oncogenes, which can trigger the growth of tumours. (Credit: Photo by Bill Branson/National Cancer Institute)
The European Patent Office (EPO) considered the oncomouse case at length and at several levels. It was only resolved in 2004 *, and we touch here on only two aspects of a very complex case. The EPO applies the patent standards of the European Patent Convention, which contains two key relevant provisions: Article 53(a) excludes patents for inventions "the publication or exploitation of which would be contrary to ordre public or morality". And Article 53(b) excludes patents on "animal varieties or essentially biological processes for the production of…animals."
The EPO decided that the exclusion on patenting animal varieties did not constitute a ban on patenting animals as such. It concluded further that the oncomouse was not an animal variety, and so did not fall within that exclusion.
In order to address the ordre public or morality exception, the EPO developed a utilitarian balancing test. This aimed to assess the potential benefits of a claimed invention against negative aspects, in this case weighing the suffering of the oncomice against the expected medical benefits to humanity. Other considerations could also be taken into account in the balancing test, such as environmental risks (neutral in this case), or public unease (there was no evidence in European culture for moral disapproval of the use of mice in cancer research i.e. no moral disapproval of the proposed exploitation of the invention in this case). The EPO concluded that the usefulness of the oncomouse in furthering cancer research satisfied the likelihood of substantial medical benefit, and outweighed moral concerns about suffering caused to the animal. In the original application, the claims referred to animals in general, but in the course of the proceedings, the patent was amended and finally maintained with claims limited to mice.
The Upjohn mouse - same approach, different outcome
The same utilitarian approach to the morality issue was applied by the EPO in the Upjohn case in 1992, but with a different outcome. The patent in question, filed by the Upjohn pharmaceutical company, was on a transgenic mouse, into which a gene had been introduced such that the mouse would lose its hair. The objective was to test products to treat human baldness and wool production techniques. The EPO again weighed up benefits (usefulness in research to cure hair loss) and harm (suffered by the mice), but concluded that in this case the latter outweighed the former, such that the exploitation of the invention was contrary to morality and therefore not patentable.
Canada - patent rejected
In Canada, the patent examiner initially rejected claims to transgenic animals on the basis that they were not included in the definition of an invention, but allowed claims on the process for obtaining the oncomouse.
The Supreme Court of Canada finally ruled in 2002 that higher life forms were not patentable because they were not a "manufacture or composition of matter within the meaning of invention" of the Patent Act **. Manufacture was interpreted as a non-living mechanistic product or process. "Composition of matter" was understood as ingredients or substances that had been combined or mixed together by a person. So while microorganisms, or an oncogene-injected egg capable of maturing into an oncomouse, may be a mixture of ingredients and thus patentable under Canadian Law, the body of a mouse was not. Moreover, the drafters of the Patent Act (1869) had not had mammals in mind and so the Act did not address higher life forms. It was recommended that, as the patentability of such life forms was contentious, the Parliament should engage in public debate to address the complex social and moral issues and close the legislative gap.
The dissenting justices, however, questioned the justification for distinguishing between lower life forms, seen as a composition of living matter, and higher life forms, which were not deemed to be compositions of matter. They held that the scientific achievement of altering the genetic material of which an animal - which does not exist in nature in this altered form - is composed, was itself an inventive "composition of matter" within the meaning of the Patent Act.
Transgenic animals pose questions for bioethics in general, and specific ethical questions in the context of the patent system. The oncomouse case highlights how different jurisdictions have dealt with the basic question of whether a transgenic animal -provided it complies with the patentability requirements - should be considered patentable subject matter; and how they have then weighed the ethical dimension of this particular technology.
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