Restoring the Equilibrium within the Patent System

(IPRinfo 2/2011)

Amina Agovic
LLD Cand, University at Helsinki, Innocent graduate school

A patent application should be rejected on ethical grounds only in exceptional circumstances. Despite this morality clause Europe still struggles with patentability of hESCs and bio-sciences inventions.

What should the patent system do about ethics and morality as found within the patent system itself? The question is easily asked, but for the past three decades, the patent system has experienced tremendous difficulty in coming up with a good answer.

Ever since the birth of modern biotechnology and new bio-sciences, the patent system has increasingly being confronted with confounding series of ethical and moral challenges.

The Hunger for Patents
For patentees, the major issues in respect of patentable subject matter are, ’scope of patentability and certainty’. New technologies, such as biotechnology (biotech) and pharmaceuticals generally take about 10 years of research before products are able to sell. It is, therefore, imperative that manufacturers and investors have a specific level of certainty that their planned commercial product will be worth the investment costs. Patents currently allow for this.

Yet, the question arises whether the traditional patent system should and if affirmative, how it should apply to the realm of living things and material of human origin. This is particularly significant as e.g. patenting human embryonic stem cells (hESCs) is intertwined with a number of values, social practices, economic conditions and historical traditions which need to be considered when evaluating new and emerging technologies.

At present, patenting requirements for mechanical innovations are the same as for material of human origin. This complies with the Article 27.1 of the TRIPs Agreement. However, when it comes to patenting hESCs and material of human origin, this clear-cut definition fails to adjust to the general nature of bio-patenting and specific ethical and social confines it carries along.

EPO decisions need to provide effective use of patent morality
European Patent Convention (EPC) explicitly incorporates ethical shields that bar patentability of the ’inventions publication or exploitation of which would be contrary to ’ordre public’ or morality …’ (Article 53(a) EPC, ’the morality clause’). Only in most exceptional circumstances should a patent application be rejected on ethical grounds. However, despite this morality clause Europe continues to struggle with patentability of hESCs and bio-sciences inventions.

The Article 54(a) EPC does not provide guidance or tools as to how patent examiners at the European Patent Office (EPO) who are primarily engineers should go about in evaluating the finer details of ethics and morality when examining morally or ethically controversial inventions.

The EPO decisions fail to clarify the issue of how to interpret the morality clause by issuing confusingly inconsistent tests with respect to patent morality: the public abhorrence test, the unacceptability test and the balancing test. In addition, instead of setting the record straight on the determination of the morality clause, the EPO Enlarged Board of Appeal (EBoA) WARF decision rejected the controversial WARF stem cell (SC) patent on the grounds that it involved the destruction of human embryos.

Carefully and cleverly worded WARF decision, allowed the EBoA to avoid a discussion concerning morality and patents and thereby, postponing the patent morality issue for another few years.

Soon after WARF ruling, the CIT patent application which claims a population of mammalian neural crest cells from other embryo cells and uses thereof by Caltech was refused by the EPO. Given that at the time of filing the application, ’the only teaching of how to prepare human neural crest stem cell cultures is the use (involving their destruction) of human embryos’ the EPO concluded that at the filing date, the method claimed necessarily involved the destruction of human embryos.

Claim 1 was held to fall under the prohibition of the morality clause taken in combination with Rule 28(c) EPC and the appeal was dismissed in May 2009. EPO Boards of Appeal cited WARF decisions G 0002/06 and T 1374/04 in its reasoning as well. Overall, it appears that the morality clause and its subsequent lack of interpretation by the EPO seems to only increase the uncertainty level about the patentability of life sciences and material of human origin.

Underlying Ethical Theories
Ethical theories within the patent system play a special role. The underlying ethical theory applied to the intellectual property rights has been utilitarianism. For example, the EPO’s discussion over patentability of hESCs are largely characterised by ethical monism, the search for a single, timeless and essential trait in which the moral standing of hESC related inventions can be grounded.

Lately however, non-utilitarian theories of intellectual property have been gaining stronger ground. In fact, applications of only utilitarian theory appear to obstruct and oversimplify the moral issues surrounding hESC and other morally controversial inventions. Thus, the ability to understand key ethical theories (i.e. utilitarian, Kantian) and principles is necessary in order draw on these viewpoints from which guidance can be obtained in reaching the decision on the patentability of hESC and likewise inventions. This renders it important to asses applications of the range of ethical theories in its patent examining procedure.

In addition, a need to consider and possibly accept a number of ethical theories rests in the fact that philosophers and ethicists are not in agreement as to which normative ethical theory might best apply to issues concerning patentability of hESCs and other morally controversial technologies.

Although different ethical theories can provide distinct and quite contradictory results, many believe that ’all these theoretical approaches throw light from different angles on one and the same problem’ and can work in a complimentary rather than a mutually exclusive manner.

Countries are embracing patent morality
Recently, countries such as Australia and New Zealand have put forth proposals to include a form of a morality clause / purpose clause in their respective patent laws. Patent examiners find examinations of morally controversial inventions doubly difficult primarily due to conflicts between moral and non-moral considerations in legal precedents.

For example, moral considerations do not always override the non-moral concerns and when there is a conflict between the two, a balancing act is required to assess what ought be done all things considered. The key problem lies in how to go about in examining such inventions.

EPO fails to cooperate with the EGE
Article 7 of the Biotech Directive grants the Commission’s European Group on Ethics in Science and New Technologies (the EGE) power to ’evaluate all ethical aspects of biotechnology’. Yet, this is the only article that has not been transposed to the EPC rules.

By comparison, Recital 44 of the Biotech Directive states that, ’… the EGE may be consulted only where biotechnology is to be evaluated at the level of basic ethical principles, including where it is consulted on patent law.’ However, there is no explicit requirement that EGE’s opinion be taken into account and despite requests for cooperation, the EPO is yet to engage in a debate on ethics and patents with the EGE.

Norway as the solution
The Norwegian patent law and most national European patent laws contains a morality clause which bans patentability of inventions that go against the ’common morality and public leader’. However, the Norwegian Parliament believed that questions surrounding ’life patents’ required particular ethical attention in addition to the morality clause stipulated by the Biotech Directive.

Thus, the Norwegian Advisory Board on Ethical Aspects of Patenting was founded in 2004. In line with Norwegian patent law, patent applications pending examination or under opposition or under court proceedings can be referred to the Ethics Advisory Board for advice on whether the invention breaches the morality clause. Norwegian safeguards are now applicable to not only Norwegian but also EPO issued patents with effect in Norway.

Ethical patent system was always the norm
It has become increasingly clear that life sciences or biotechnological innovation cannot be adequately handled in the same manner as mechanical and traditional inventions. No longer is it a matter whether we need ethics within the patent system but it is a task of how to implement ethical policies in patent law.

The ethical evaluation of hESC and morally controversial inventions should become part of the standard patent examining procedure; thereby becoming a vision of a balance between the society and the economy and the one of hope, not alienation. A patent system that has the functional morality clause entrenched in its core would secure a process of interpretation that respects a moral conception of patent law and would easily adapt to ethical issues posed by new bio-technologies and to the society’s changing ethical norms.

Considering the remarkable progress in stem cell and bio-sciences and their immense reliance on patents, a rejuvenated patent system which safeguards the social welfare, may prove the best and the only way to manage ethical and social issues of hESC and other emerging bio-technologies related inventions.

References

Howard Florey/Relaxin (T74/91) [1995] OJ EPO 6/1995 (’Howard Florey/Relaxin’)

Harvard/Oncomouse (T 0019/90 – 3.3.2) 1990 OJ EPO 476

California/Stem Cells (T 522/04) 2009 EPOR 45 (’California/Stem Cells’)

Stem Cells/WARF (T 1374/04) EPO OJ 2007, 313 (’Stem Cells/WARF’)

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Official Journal of the European Communities 30.7.1998, L 213/13