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.
This answer will begin by stating the extent to which biological material can be patented and then discuss the relevance of traditional justifications to modern patent law.
The term “biological material” potentially refers to microbiology and biotechnology. Microbiology is associated with production techniques for pharmaceuticals and other substances which use micro-organisms in controlled reactions. Biotechnology has a broader scope and generally refers to the engineering of genetic materials towards a range of practical ends. Inventions are patentable if they meet the criteria set out in section 1(1) of the Patents Act 1977 (“the PA”).
Since the Court of Appeal’s decision in Upjohn’s Application [1977] R.P.C. 94 methods of treating the human or animal body have been unpatentable on the basis that treatment was not capable of industrial application, this decision was consolidated by article 52(4) of the European Patent Convention 1973 (“the EPC”) and subsequently by sections 4(2-3) of the PA. Traditionally this exception was justified by the view that the medical profession should not be hindered by the commercialisation of practice. Although this justification remains essentially the same today, it has been re-labelled with different language as part of “public health policy” in the European Union.
Despite article 53(b) of the EPC, section 4(1) of the PA and articles 3, 4(1) and 4(3) of the Biotechnology Directive 98/44 (“the BD”) processes for the production of certain animal and plant varieties have been patented. A number of cases illustrate this development, the case law centres on the scope of the phrase “essentially biological” in article 53(b) of the EPC. Modern biotechnology has gone beyond known biological and classical breeders’ processes and is therefore no longer essentially biological. Patents were granted in: Ciba-Geigy/propagating material [1984] O.J. EPO 112, Lubrizol/hybrid plants [1990] O.J. EPO 59and Harvard/Oncomouse [1990] O.J. EPO 476.
“The exclusion of varieties and essentially biological processes in part expresses ethical objections to human intervention in the generation of animals and plants, objections which may equally be raised on the moral and public policy grounds. But this exclusion has its basis primarily in the expectations of traditional industries and professional expertise of plant and animal breeding. Those industries now find themselves participating in biotechnological and similar grand-scale high-investment strategies, for which innovators and their financiers expect protection against competition and look towards the broad range which the patent system is most likely to provide. The European Patent Office’s interpretation of the exclusion, which was to have been entrenched in EC national laws by the proposed BD, goes as far as it can to accept this new development. Even without the BD, it is quite likely that, in individual states, courts and offices will prove reluctant to depart from the emergent European position.”
Section 1(3) of the PA excludes the patenting of inventions contrary to public policy and morality. In the past this had been a “seemingly underused provision” however, this provision has become important in the context of patenting biotechnological inventions.
In the United States, the Oncomouse technology was granted a patent and therefore a monopoly as regards production and licensing as a reward for the research carried out in this field and as a reward for investment. This gave effect to the Supreme Court’s decision of Diamond v. Chakrabarty where it was stated with typical American gusto that: ”anything under the sun made by man apart from a human being should be regarded as patentable”.
Traditionally patents have been granted for a number of reasons, for example: to incentivise inventors and to increase knowledge. In summary they are largely economic reasons. In Europe ethical considerations have been confused with concerns over the best way to limit the scope of monopoly rights granted by patent claims. Nott believes: “moral and public policy objections should play no part in the question of grant…patent office examiners lack any expertise to form the appropriate judgement”. This view is too extreme to have any practical application, a balance must be struck between morality and the promotion of competitive technological development.
Commentary:
This answer is quite strong on answering the first limb of the question relating to the patentability of biological material, but does not contain much content analysing the traditional justifications and in particular Locke’s labour theory. It is however very well-written and argued. The writing style is logical, succinct and the content is accurate. The student also makes an effort to refer to relevant statute and case law to support and illustrate the ideas presented. The final paragraph contains concluding remarks which directly address the first limb of the question.