European Patent Law Developments In Stem Cell Research

Medical scientists and cell biologists have long heralded stem cell research as the next major revolution in medical therapy. However, the use of stem cells in research and treatment raises a number of ethical questions.

The patenting of inventions relating to stem cells and related technologies is extremely controversial and raises issues of ethics, morality and public interest. Worldwide, patent protection has been sought (and, in some instances, granted) for inventions relating to stem cell lines per se, methods of deriving, growing, preserving and selecting stem cell lines, methods of therapy using stem cells, and methods of genetically modifying and cloning stem cells.

The European Patent Convention and the UK Patents Act are the laws dictating what can and cannot be patented in Europe and the UK, respectively. One of the fundamental requirements is that patents must not be granted for inventions that are contrary to public policy or morality. The concept of morality as applied by the European Patent Office is supposed to reflect the culture inherent in European society and civilisation. Accordingly, inventions the publication or exploitation of which is not in conformity with the conventionally accepted standards of conduct pertaining to this culture, are not to be granted patent protection because they are contrary to morality. The assessment of whether or not the exploitation of a particular invention is to be considered contrary to morality by the European Patent Office is not dependent upon any national laws or regulations. Equally, an invention is not automatically deemed patentable if its exploitation is permitted in some or all states which are party to the European Patent Convention.

The patenting of biotechnology inventions is further regulated by the European Biotechnology Directive of 1998. This directive was intended to promote research and development in the field of biotechnology in the European Community through the removal of legal obstacles arising from differences in standards relating to what may and may not be patented in national legislation and case law. In order to address the ethical concerns voiced during its drafting, the European Biotechnology Directive also includes a clause which prevents the patenting of inventions that are contrary to morality. In addition, the Biotechnology Directive also explicitly states that “uses of human embryos for industrial or commercial purposes” should not be patentable.

As a result, the European Patent Office has, in the past, refused to grant patents for inventions relating to cells derived from human embryos. However, research has meant that stem cell technology has quickly moved on, and the interpretation of whether something constitutes industrial or commercial use of human embryos has become increasingly unclear. For example, whilst stem cell cultures traditionally required the destruction of a human embryo, this is no longer necessarily the case in light of technical advances.

The European Patent Office currently applies a broad interpretation to the definitions provided by the European Biotechnology Directive of what may not be granted patent protection. As a result, the European Patent Office has refused to grant patents for inventions that involve, at any stage, the use of a human embryo. This is in contrast to the approach currently adopted by the UK Patent Office. According to guidelines issued by the UK Patent Office, human embryonic pluripotent stem cells are patentable in the United Kingdom. By “human embryonic pluripotent stem cells”, the UK Patent Office means “stem cells, which arise from further division of totipotent cells and do not have the potential to develop into an entire human body”. Nevertheless, according to these guidelines, i) processes for obtaining stem cells from human embryos; ii) human totipotent cells having the potential to develop into an entire human body; and iii) methods of culturing or propagating human totipotent cells may not be protected by patents.

However, the European Patent Office now has the opportunity to review its interpretation of the exclusions from patentability. Its current practice has been challenged by the Wisconsin Alumni Research Foundation, whose patent application relating to a cell culture comprising primate embryonic stem cells was refused by the European Patent Office. The Wisconsin Alumni Research Foundation subsequently appealed against this refusal and the case has been considered by the European Patent Office's Board of Appeal. It was recognised that this case raises important legal issues and so the Board of Appeal has moved to clarify the situation by referring a number of questions relating to the interpretation of what constitutes industrial or commercial use of human embryos to the Enlarged Board of Appeal, the division of the European Patent Office charged with deciding points of law.

The questions referred to the Enlarged Board of Appeal concern complex and inter-related issues of technology, morality and patent law. The answers to these questions could set an important precedent for European patent applications which relate to human embryonic stem cells. On the one hand, the decision could result in the current situation being maintained. However, it is possible that the Enlarged Board of Appeal will advocate a change in the way the European Patent Convention is interpreted, so that the exclusions from patentability relating to human embryo cells is interpreted more narrowly. This could lead to the grant of many more European patents in this technical field, including patents directed stems cells themselves and uses of such cells in therapeutic treatments, where it is possible to carry out an invention without the use or destruction of human embryos.

Third parties have been able to provide the European Patent Office with their views on the issue and over 160 submissions have been made by various parties including numerous individuals, religious groups and national patent offices.

The UK Patent Office has made a submission and it's position is that patents for stem cells should not be excluded on morality grounds because there are different strands of opinion regarding morality across the states that are party to the European Patent Convention. According to a poll conducted in the United Kingdom, human embryo research is generally not considered to be unethical and it has been argued that the European Patent Office should not adopt a Europe-wide stand where such differences in opinion exist.

The UK Patent Office also suggests that the European Patent Office should not be required to act as a moral arbiter between strands of opinions and that it should not refuse patents for inventions the exploitation of which would be considered as moral by a significant strand of respectable opinion. This is an interesting point. The European Patent Office is an international organisation charged with the task of granting European patents. The premise behind the patent systems around the world is that patents encourage innovation by enabling innovators to protect the investment they have made in developing their inventions. The prime concern of the patent offices around the world should be whether or not an invention is worthy of patent protection. That is, whether or not the invention is new and sufficiently innovative to warrant the grant of a patent.

Importantly, a granted patent allows the owner of the patent to prevent others from using the invention protected by that patent. A granted patent does not give the patent owner the right to exploit the protected invention. This means that the existence of other laws must also be taken into account when ascertaining whether or not an invention may be exploited. In the field of stem cell technology, such laws can include, for example, EU legislation controlling genetic experimentation and UK Health and Safety Executive controls. It is arguably the role of the individual national governments or the EU to decide what is morally acceptable and what inventions may be exploited, regardless of whether or not they have been granted patent protection.

Nevertheless, the European Patent Office has, in the past, made decisions relating to moral issues and some such decisions have gone against the vocal opinions of ethical groups. Most notable amongst such decisions was that relating to the so-called “Harvard Oncomouse”. This patent related to a mouse genetically manipulated by insertion of an activated oncogene. The European Patent Office decided that the invention was not necessarily contrary to morality if, in a careful weighing up of the suffering of the animal and the envisaged medical benefit to man, the advantages outweigh the negative aspects. The envisaged medical benefit is likely to once again be an important factor in the considerations of the Enlarged Board of Appeal.

The UK Patent Office has confirmed that it recognises the enormous potential of stem cells in the development of therapies and considers that “on balance the commercial exploitation of inventions concerning human embryonic pluripotent stem cells would not be contrary to public policy or morality in the United Kingdom.” It remains to be seen whether or not the Enlarged Board of Appeal agrees with this. In the meantime, parties seeking to protect inventions relating to human stem cells should consider applying for national patent protection in the United Kingdom, in addition to European patent protection, in order to make the most of the UK Patent Office's current stance.

Siân Gill 01 Jan 2007

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