Does the patenting of biological material conflict with traditional justifications for patent law, and in particular John Locke's (1632–1704) Labour theory?
Refer to the relevant statute and case law to support your answer.
The principal purposes of a patent law system are to recompense invention, encourage disclosure of inventions, thus stimulating further advancements, and protect ideas in the public domain. In return for a limited monopoly, the traditional justifications for the patent law regime rely on the concept of reward for labour (the ‘Labour theory’) and the disclosure of useful inventions in the public interest, among others. However, these traditional justifications for the legal protection of intellectual property rights often conflict with modern moral and ethical considerations, especially in connection with biotechnological inventions. Biotechnology is the development of commercial products from biological processes.
The UK patent law regime is regulated by the Patents Act 1977. Under the Act, inventions are patentable if they meet the criteria set out in s 1(1) of the Patents Act 1977. However, s 1(3) of the Act excludes the patenting of inventions contrary to public policy and morality. This provision has become increasingly important in the context of patenting biological inventions. Further, the Act was amended by the Patent Regulations 2000 inserting s 76A and Schedule A2 which implement the EU Biotechnology Directive. Biotechnological inventions are now defined in s 130 of the Act as ‘products or processes containing biological material, that is, material containing genetic information and capable of being reproduced in a biological system’.
Does the patenting of biological material conflict with John Locke’s (1632–1704) ‘Labour theory’ which was conceived several centuries ago? It is well known that Locke identified labour as the original and just foundation of property. In brief, Locke’s was a labour theory of property. Locke viewed private property ownership as legitimate and he argued that the labourer should be rewarded for his efforts. But, he stated that the reward for labour was conditional, so that ‘there must remain objects of similar qualities in sufficient quantities to supply others’. In other words, Locke was concerned to grant some form of reward, so long as that reward was not detrimental to the public interest.
In relation to biotechnological inventions, the conditional aspect of Locke’s labour theory is reflected in the arguments propounded by some scientists in relation to the Human Genome Protect (‘HGP’). The HGP identifies all the human genes and determines the sequence of base pairs for the entire human genome, storing information in databases for further advancements in biotechnology. Succinctly, the genome is the ‘complete set of genetic information of an organism’. On the one hand, the raw sequence of the human genome is a natural manifestation of nature, not made by the human hand. On the other hand, the other format consists of the cloned or isolated and purified partial DNA fragments. The DNA fragments must be excised from the natural context of the human genome, isolated, purified and cloned before scientists can study them. Since the sequenced gene fragments do not exist in their natural state and are therefore ‘not nature’s handiwork’, they are patentable subject matter.
However, certain scientists argue that instead of allowing human genes, tissues and organs to become privately owned commercial property controlled by business for a twenty-year term, the intellectual property law community should work towards creating a global treaty to jointly administer data concerning the human genome and the gene pool for other plants and animals on behalf of future generations. In line with Lock’s Labour theory, the community should ensure that sufficient genetic information is available for use by others.
More recently, modern legal academic Professor Michael Pendleton has argued against promoting private interests because in his view progress has been made only by re-combining pre-existing knowledge. Pendleton’s theory provides that ‘no one own an idea . . . all ideas lie within the public domain’.
The creation of a global treaty to jointly administer data concerning the human genome and the gene pool for other plants and animals on behalf of future generations could be said to be a combination of Locke’s Labour theory (don’t take more than you need) and Pendleton’s theory that an invention cannot be attributable to an individual or small group of people. Elaborating further on Locke’s Labour theory and in line with Pendleton’s theory, Nozick asserts that the labourer should be entitled only to the ‘value added’, not to the total value of the resulting product. Further, it is not only the object and the labour added that have value, but the thoughts and ideas of those who came before (affirming Pendleton).
The counter-argument is that a patent monopoly is the key means of rewarding research-based industries, such as the biotechnological and pharmaceutical industries, enabling them to recoup their massive research and development invest during the patent term where they have the exclusive right to exploit their invention. It is estimated that it takes on average more than ten years to create a useful biotechnological product or process and to market it. Patents protect against competition at the vulnerable early stages of development and converts a risky investment into a saleable commodity. In particular, the patent system protects a patentee’s invention from prospective infringers by preventing others from copying, making, using, offering for sale, or selling another’s work without consent. However, most prospective gene patentees seek patent rights on genetic sequences, which lack intrinsic marketability or definite utility. Should DNA sequences be protected by patents? Is there a need to put an end to the international rush to patent DNA fragment sequences with no known function? Clearly, however, genetic research contributes to the development of many of today’s breakthrough pharmaceuticals and diagnostic tests.
Nevertheless, some scientists object to patents over biological material because of the effect on research in that permission needs to be obtained, licence fees paid in order to use the information. Indeed, one of the strongest arguments opposing DNA sequence patenting is the assertion that such patenting hinders innovation rather than promoting it and so holders of DNA sequence patents have the capability to deprive researchers and physicians of any use of that sequence for diagnosis, treatment, or development of disease treatments. It is argued that scientific integrity is being compromised by commercialism and the giving of property rights over ‘nature’ and further that patent monopolies are being used as a device to monopolise industries and restricting the flow of ideas. In the scientific community, knowledge is usually developed in a cooperative manner through the open disclosure of new knowledge and peer testing of that knowledge. Accordingly, the growing trend towards the commercialisation of research has led to the practice of promoting secrecy and hindering the exchange of information amongst researchers in biotechnology. It is true that information-sharing between laboratories seems to be inhibited by patents and licensing. In other words, until researchers acquire patent rights, publication of research findings may be delayed and the commercialisation of genetic research diminishes the collaborative efforts in scientific research.
Certainly, there are criticisms of the current system of granting patents for biotechnological inventions. However, historically, there is a long tradition in granting patents for purified natural products such as that granted to Louis Pasteur (1822–95) for yeast ‘free from organic germs of disease’. In Parke-Davis & Co v H.K. Mulford & Co (1911) it was held that purified human adrenaline was patentable because, through purification, it became ‘for every practical purpose a new thing commercially and therapeutically’. Some hold the view that as gene sequences already exist naturally and are discovered rather than invented, they should not be patentable. How can the genetic codes which stimulate and codify the make-up of every living cell and organism be bought and sold? This view is supported by the BioIndustry Association, the trade industry representing the UK biotechnology industries.
In addition, many people believe that it is morally and ethically wrong to treat life, and thus biological material, as commercial property. DNA sequence patenting has been attacked on religious grounds based on the notion that genetic manipulation is the same as ‘playing God’, and that the fruits of such work should not be rewarded with patent control.
On the other hand, the patent system significantly benefits society by expediting the discovery of new medications, technologies and non-infringing improvements, while decreasing consumer costs through the development of non-infringing substitutes. Further, the patent law principles may already provide the means to adapt to biotechnological inventions. For example, as the process of isolating gene sequences becomes more commonplace, it will inevitably become harder to show an inventive step which is a legal pre-requisite to the grant of a patent. It is also interesting to contrast the case of biological material with that of chemical elements in the period table. Such elements were largely non-obvious when first isolated and purified, and very useful, but they were not held to be patentable because they were discoveries of nature, despite the human ingenuity involved in isolating them. In conclusion, there is need to find a viable compromise that protects knowledge in the public domain and encourages further biotech research.
Commentary:
A good answer will critically assess whether the traditional philosophical rationales justifying the grant of patent monopolies are still relevant when considering modern dilemmas over the patentability of certain biological material. This answer effectively deploys the relevant statute and case law at each point of the analysis. It provides a comprehensive analysis of the two limbs of the question illustrated with topical and relevant examples. The answer also presents a balanced discussion by providing counter arguments.