An early major case in which the morality objection was considered by the European Patent Office (EPO) was the opposition to the DuPont/Harvard ‘Oncomouse’ patent. The
The Oncomouse quickly came to be seen as an ideal test subject for toxicology studies on new cancer drugs and therapies and, although it was hailed as a wonderful tool at the time, few foresaw the consequences of the monopoly over the technology that the patent gave DuPont. Many cancer researchers now assert that the high royalties demanded by DuPont for the use of the technology, and their overly broad interpretation of the scope of the patent, have created practical obstacles to basic research and has slowed the pace of progress.
When the morality objections to the Oncomouse patent were considered by the EPO, the EPO provided the following guidance in relation to the moral issues: “the possible detrimental effects and risks (i.e. the suffering to the mice) had to be weighed and balanced against the merits and advantages (the benefit to cancer research).” In this case, the EPO deemed that the balance fell in favour of granting the patent.
More recent guidance on how to interpret the ‘morality’ exclusion was given in a European Board of Appeal decision of 2005 entitled ‘Euthanasia Compositions’, in which the board found that, for this exclusion to apply, the invention must lend itself only to immoral forms of exploitation. The patent in debate claimed a chemical composition which, when administered, would cause a ‘lower mammal’ to die. The composition was intended for use by vets, generally for the purposes of saving the animal in question further suffering. Opponents to the patent objected on the basis that the composition could also be used for human euthanasia, merely by adjusting the dosage, and further that the research necessary to develop the invention had involved killing animals. The board rejected these arguments and upheld the patent.
A recent patent application being disputed on moral and ethical grounds is the J Craig Venter Institute’s application to patent the world’s first synthetic life-form. This patent has elicited a great deal of comment, emotion and debate, with the Canadian-based ETC Group (which monitors developments in biotechnology) calling on patent offices to reject all applications relating to synthetic life forms.
The Venter Institute, run by Dr J Craig Venter, the controversial DNA researcher who led a private sector effort to sequence the human genome, has filed worldwide patent applications for a ‘minimal bacterial genome’, including
at the EPO.
Venter’s team have deciphered the minimal gene set required for a free-living organism to live and replicate. The minimal bacterium claimed can be used as a carrier for additional genes and, in theory, could therefore be instructed to produce any number of products from drugs to fuels.
The ETC Group has written to the World Intellectual Property Organisation and the US Patents and Trademarks Office objecting to the Venter application on the basis that its exploitation would be contrary to public morality and safety. They have voiced fears that the patent signals “the start of a high-stakes commercial race to synthesize and privatise synthetic life forms”, even going so far as to allege that “for the first time, God has competition”. The ETC Group’s objections include the following:
- The risks associated with the bacterium — they argue that the minimal bacterium “could be harnessed to build a virulent pathogen that could pose grave threats to people and the planet”. These concerns are given weight by magazines such as Nature which, in its October 2004 issue, stated: “If biologists are indeed on the threshold of synthesizing new life forms, the scope for abuse or inadvertent disaster could be huge.”
Contrary to the ETC Group’s allegation however, the Venter Institute claims that its minimal bacterial genome could, for example, the key to ameliorating climate change through cheap energy production.
- The impact on other researchers in this area — the ETC Group argues that the commercialisation of the patent would be contrary to public policy given the extremely broad scope of the claims, as the patent would give the Venter Institute a monopoly over a number of fundamental tools and components of synthetic biology which the ETC Group argues should be freely accessible to all researchers in the field.
The ETC Group urges that, before commercial research and patent applications in the field of synthetic life are allowed to progress any further, society should consider the “social, ethical and environmental implications of synthetic life”. Synthetic biologists, including those at the Venter Institute, do acknowledge that there is potential for misuse and accidents and have put forward governance options that attempt to reduce safety and security risks without imposing undue burdens on either researchers, industry or government.
How do these arguments affect the way in which patent applications for synthetic life, or for biotechnology inventions in general, should be dealt with? This is an extremely broad field and a blanket ban would not be appropriate. Any blanket ban would suffocate commercial research in the area affected — allowing inventions to be patented yields many benefits to society by stimulating innovation and private investments in research.
In 1998, the European Union (EU) attempted to make some headway in dealing with these issues, through the adoption of a European Directive aimed at clarifying the position on the patentability of biotechnological inventions throughout the EU. The Directive confirms that an invention is not prevented from being patentable merely because it concerns a product “consisting of or containing biological material” or a process “by which biological material is produced, processed or used”. It also lists a number of inventions which are excluded from being patentable including, for example, the simple discovery of the sequence of a human gene and processes for cloning human beings. Although useful, this Directive leaves many areas untouched — for example, it does not, in principle, exclude the Venter application from being patentable in the EU as a biotechnological invention — micro-organisms such as bacteria, or gene sequences for such micro-organisms are not included on the list of
excluded ‘inventions’.
Given that a blanket ban of patents in any field is impractical and unworkable, patent applications can only be considered individually — on their own merit. The approach of the EPO to the Venter application should, as with the Oncomouse patent, be to consider the benefits of the patent against the risks associated with its commercialisation. Assuming that the Venter application passes all other validity requirements for a patent, it seems unlikely that it will fail on the basis of the morality objections — only some of the potential uses of the invention are morally objectionable and, following the more recent guidance in the ‘Euthanasia Compositions’ case, this should not prevent the patent being granted.
David Knight is a partner and Susanna Thompson a solicitor in the intellectual property and life sciences groups at Field Fisher Waterhouse.
