Bioethics and Patent Law: The Relaxin Case
This article introduces an occasional series, which highlights issues that have arisen in some significant patent law cases concerning biotechnology. We begin by outlining some bioethical questions that arise in connection with patenting biotechnological inventions; and we look at how European Patent Office (EPO) jurisprudence dealt with the issues surrounding the patenting of a human gene in the Relaxin case.
Biotechnology is booming. Innovation in biotech is producing new medicines, treatments and processes with the potential to save or transform the lives of millions. As new technological frontiers are crossed, our expectations continue to rise. But so too do the complexities of the associated bioethics, i.e. the ethical questions relating to the implications and applications of biological research. One aspect of this complex area concerns the way in which biotechnological inventions are protected – or excluded from protection – by intellectual property (IP) rights.
When considering bioethics in an IP context, some critical distinctions have to be kept in mind. For instance, ethical arguments for or against permitting researchers to undertake research on certain technologies (e.g. on embryonic stem-cells) should be distinguished from the rights or wrongs of permitting the outcomes of such research to be patented. But the patent system does not exist in a moral vacuum. The intersection between bioethics and IP lies rather in questions such as: Is it morally acceptable to grant exclusive patent rights over a particular technology, such as isolated DNA sequences? What issues of prior informed consent arise when genetic resources are used to develop a patented invention? What ethical concerns arise regarding the way that exclusive rights over a technology are exercised, such as patents on diagnostic tools?
The same, but different…
In the patent laws of most countries, the same basic rules and principles govern the patenting of biotechnological inventions as other technologies: only genuine inventions – not mere discoveries - are eligible; the same conditions of novelty, inventive step, and industrial applicability apply; the applicant must fully disclose how to carry out the invention; and so forth.
But biotechnology is special, not least because it is based on living organisms. Indeed, biotechnological inventions can be self-reproducing and self-disseminating, as in the case, for example, of a genetically engineered seed (which may itself be considered an invention if it is truly novel and inventive).
Patent law has accordingly developed certain special rules for biotechnological inventions. These include public interest exceptions to patentable subject matter – some countries exclude patents on plants or animals, for instance – and some provide special disclosure requirements relating to inventions based on genetic resources. There are also some distinctive legal mechanisms, such as the deposit of micro-organisms, when access to the actual materials is needed to understand the invention.
Patenting human genes - The case of relaxin*
The central debate on bioethics and IP revolves around the morality of what is loosely referred to as patenting life. This is not new. Back in 1873 Louis Pasteur received a patent on isolated yeast, a living organism. Debate intensified from the 1980s onward, when patents began to be filed on human genes.
The jurisprudence of the EPO offers a more recent illustration of legal and ethical concerns about patenting genes. In question was a patent for relaxin, a hormone which relaxes the uterus during childbirth, and which, it was hoped, could have medical application in reducing the need for caesarean deliveries in difficult pregnancies.
Relaxin from pigs was first described in 1926,. but it was not until 1975 that the Howard Florey Institute in Australia isolated and determined the chemical structure of a human form of the hormone . Their subsequent research revealed a second form of human insulin, the existence of which had not previously been suspected. The structure of human relaxin was found to differ from other species, such that only human relaxin could be used for the medical purpose envisaged.
In order to obtain sufficient quantities of the hormone to explore its therapeutic use, it was necessary to manufacture it in synthetic form. So having isolated the nucleotide sequence that coded for relaxin, recombinant DNA techniques were used to clone the gene, making it possible subsequently to produce synthetic relaxin.
In the Howard Florey Institute’s patent application, the claimed invention concerned the gene coding for the unexpected second form of human relaxin, and the synthetic form produced through cloning technology. A patent was issued in Europe in 1991, but opposed in 1992 by members of the Green Party in the European Parliament. The following summarises some of the legal and ethical issues addressed in this case.
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Challenge by the opponents
• The claimed invention was not novel, since the gene encoding relaxin had always been present in the female human body.
• There was no inventive step, because a conventional method was used to isolate the DNA.
• Relaxin was a mere discovery, and as such “no more patentable than the moon or a new animal found in a remote area.”
• The patent was contrary to morality or ordre public;
• Isolating a gene from tissue taken from a pregnant women was an offence to human dignity, as it used the pregnancy for a technical profit-oriented process;
• Patenting human genes "amounts to a form of modern slavery since it involves the dismemberment of women and their piecemeal sale to commercial enterprises;”
• Patenting human genes was tantamount to patenting human life, and would as such be intrinsically immoral.
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Response by the EPO Opposition Division
• This gene sequence was itself novel, as it was in the form of complementary DNA, which does not exist in nature. The form of relaxin that it coded for was also unknown until the inventor isolated it for the first time.
• As the inventor was providing to the public for the first time a product whose existence was previously unknown, the method used to obtain it was immaterial.
• A discovery of a substance freely occurring in nature was not patentable; but if the substance was newly isolated and characterized, then it was not a mere discovery; it was an industrially applicable technical solution to a technical problem.
• It would not be viewed by the public as too abhorrent to be patentable.
• The tissue was donated with consent within the framework of gynaecological operations. Many life-saving substances were isolated in this way, patented and welcomed by the public;
• Gene patents do not confer any rights over individual human beings. There was no dismemberment of humans since the point of the invention was to synthesize the hormone;
• "The patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned it would be impossible to reconstitute a human being from the sum of its genes". No moral distinction was seen between the patenting of genes and the patenting of other important human substances, such as adrenaline.
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Next case: The Harvard Oncomouse
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* Howard Florey/Relaxin; Oppositions by Fraktion der Grünen im Europäischen Parlament; Lannoye; EPO 6/1995 388
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