By Catherine Saez
In order to explore the relationship between intellectual property rights and life science innovations, the World Intellectual Property Organization (WIPO) is organising policy symposia to identify and clarify the intellectual property dimension in the life sciences.

In a world where biotechnology is booming and new technological frontiers are being crossed, new challenges arise such as ethical questions relating to the implication and applications of biological research. Patent agencies, industry and civil society were invited on 4 September to share their thoughts and experience on the use of the intellectual property system in bioethics.

As Antony Taubman, acting director of the WIPO Global IP Issues Division described it, biotechnology is based on living organisms which raises distinct ethical questions.

Countries have adopted diverse legislative responses to the challenge. There are also emerging international norms such as the Universal Declaration On Bioethics and Human Rights adopted by the United Nations Educational, Scientific and Cultural Organization (UNESCO) members in October 2005 under which member states committed themselves to respect and apply the fundamental principles of bioethics.

However, Taubman said, fundamental questions remain. He identified four types of ethical questions: concerns about life sciences technology; consequences of a national authority granting exclusive IP rights over a technology; implications of an individual, a firm or an institution seeking exclusive IP rights over a technology; and how IP rights are exercised in practice, citing examples for each.

The European Patent Office (EPO) has developed guidelines on what is patentable on the basis of ethical considerations. For example, biotechnological inventions involving elements isolated from the human body or produced by technical means (including the sequence or partial sequence of a gene) are patentable, said Maria Fotaki, director of the EPO’s Biotechnology Directorate.

However, according to Article 53 of the European Patent Convention (EPC), which states the exceptions to patentability, no patent can be granted to inventions which would be contrary to morality or “ordre public” if they were commercialised, according to Fotaki. Thus the cloning of human beings or the industrial or commercial use of human embryos is not patentable, she said.

Nevertheless, the case of human embryonic stem cells remains a dilemma. It is neither addressed by European Union Directive 98/44/EC (on the legal protection of biotechnological inventions) nor by the EPC. The European Group on Ethics in Science and New Technologies (EGE), an EU advisory group, released an opinion in May 2002 advising that unmodified stem cells were “too close” to the human body to be patentable, but stem cell lines which had been modified by in vitro treatments or genetically modified so that they have acquired characteristics for specific industrial application may be patentable.

In addition to patenting, according Fotaki in Europe there are even sizable differences between countries on treatment of embryonic stem cells for research purposes. Different pending legal cases in several countries “are rousing questions that may be useful to the debate” she said.

Switzerland’s New Patent Law

The Swiss Confederation, meanwhile, has been working on a new patent law. It has been approved by Parliament and if no referendum is brought forward before 12 October, the new law will be applicable, according to Felix Addor, deputy director general of the Swiss Federal Institute of Intellectual Property. It will come into action in July 2008, he said. The law, Addor said, was based on the principle that too much protection or too little protection would be equally bad for both inventors and the public. The new law represents a middle way, he said.

As for other countries, the human body is at the heart of preoccupations when it comes to patent applications. Switzerland like the EPO regards as not patentable any parts of the human body or the embryo, or a naturally occurring sequence or partial sequence of a gene.

There is also an ethical controversy concerning human stem cells, because to obtain stem cells from a human embryo means that the embryo has to be destroyed. However, contrary to the EPO, the new Swiss patent law would render patentable modified embryonic stem cells as well as procedures to obtain such cells. The new law also would allow any person to file an opposition against a granted patent if the ethical limits seem not to be respected, according to Addor.

But Addor asserted that the new Swiss patent law contributes to new developments in the international context with the introduction of a requirement to declare the source of genetic resources and traditional knowledge in the patent application. Another source said an increasing number of national laws include such a provision, adding that Switzerland also has made proposals on this issue at the international level.

The goal, Addor concluded, was to reach a balance between the patent owner who needs research incentives and exclusive rights, and the public which is entitled to knowledge, transparency and research, and private use.

On bioethics, a Novartis representative said that proper understanding of ethical issues is essential, and that an external ethical review is mandatory. The representative said that legal systems in general do not provide clear guidance, and that the different cultural, moral and ethical values throughout the world add difficulty to the process.

The patent system cannot be the primary tool to deal with ethical considerations said Peter Thomson of the Novartis’ corporate intellectual property office, adding that other legal institutions or instruments are needed. Nevertheless, he found that enforcing the patent protection system is important. “A functionary patent system is essential for development of new pharmaceuticals and treatments,” he said.

Meanwhile, Julie Morgan, Asia Pacific program coordinator non-profit Franciscans International, said civil society agencies ought to base their activities and development of conceptual frameworks for public policy on the experience of local people and local ecosystems. Experience of vulnerable communities should be privileged in policy formulations, she said.

“Civil society may not want to accept a novel application of a therapy derived from a new discovery in genome sequences but will be interested in seeing whether or not the proposed application advances both human dignity and the common good,” said Morgan.

Human-Animal Hybrid Research Permitted in UK

On 5 September, the United Kingdom Human Fertilisation and Embryology Authority (HFEA) gave permission, with strict framing, for research on human-animal hybrids. “Having looked at all the evidence, the authority has decided that there is no fundamental reason to prevent cytoplasmic hybrid research. [T]his is not a total green light for cytoplasmic hybrid research, but recognition that this area of research can, with caution and careful scrutiny, be permitted.”

This is yet another step into unknown territory which will likely fuel further debates on research and patenting biotechnological inventions.

The next WIPO public symposia on life sciences are scheduled for 19 September (on public health) and 16 November.

Catherine Saez may be reached info@ip-watch.ch.