The following article, written by David Rickard and Colm Murphy, appeared in Times Online on 9 July 2009.
End Muddle Over Stem-Cell Patents or US Will Race Ahead
This week’s news that synthetic human sperm have been grown from embryonic stem cells for the first time raises the prospect of a breakthrough in male infertility treatment, but it also highlights the legal and ethical hurdles that will need to be overcome before the full potential of stem cell research will be realised.
In the US, one of President Obama’s first Executive Orders on taking office was to reverse the ethics-driven ban on US federal funding for human embryonic stem cell (hESC) research. This is good news for anyone hoping for a cure for Parkinson’s, Alzheimer’s, diabetes or other debilitating conditions, but not for the European Union (EU) which, until now, has had a clear advantage in stem cell research.
The emergence of the US as a key player in stem cell research will make it attractive to both researchers and investors, at a time when inconsistencies in the legal framework designed to position the EU at the forefront of biotechnology opportunities are threatening to undermine investor confidence and, ultimately, funding for such research in Europe.
Until recently the EU has had fewer legal restrictions on funding for stem cell research than in the US, but the ethical debate has affected the way in which such work can be patented within the EU with resulting implications for its funding and commercial exploitation.
Stems cells are significant because they can transform into other cell types and perform the function of that cell. Adult stem cells are found within certain human organs and tissues and normally can differentiate only into that particular tissue. Embryonic stem cells remain unspecialised for longer. Indeed, some are so unspecialised that a single cell can develop into a human being; others don’t have this ability but can still transform into any human cell type.
In the EU, patenting of hESCs is governed by EU Directive 98/44/EC (The Legal Protection of Biotechnological Inventions) which was intended to create a consistent approach across Member States so that Europe could fully exploit biotechnology opportunities.
The Directive prevents patents being granted for the human body at various stages of development, including the embryo stage. Cells which could develop into a human being cannot be patented, but adult cells and those which can develop only into body components should, in practice, fall outside the Directive and may be patentable. Whether any resulting patent can be enforced throughout Europe is another question.
Most patents in Europe are granted via the European Patent Office (EPO) which has adopted the Directive’s provisions. However, European patents must still be enforced in individual Member States whose national courts may interpret the Directive differently. In some counties there has even been resistance to implementing the Directive into their national law on the basis that no patents should be granted on inventions using stem cells. Of the national patent offices, the UK Intellectual Property Office (UKIPO) has taken a relatively liberal approach, although the use of in-vitro derived sperm for reproduction was banned by the Human Fertilisation and Embryology Act last year, and this is the law that will have to be considered following this week’s news about synthetic sperm. The UK and other countries will need to examine such issues if the EU’s lead in stem cell research is to be maintained.
The Directive prevents granting of patents that involve “use of embryos for industrial or commercial purposes”, and the EPO had used this as a basis to refuse patents that use cells derived from a human embryo. However, in November 2008 the Enlarged Board of Appeal of the EPO ruled that stem cells cannot be patented if the means of obtaining them requires destruction of a human embryo. This potentially opens the way for patenting of stem cells that are not obtained directly by means involving destruction of an embryo.
Until recently stem cells could only be obtained in this way, and therefore the EPO’s interpretation of the Directive amounted to a de facto ban on patents for any use of such cells. However, recent advances mean that stems cells can now be obtained without destroying embryos, such as those which are generated from adult stem cells; they can also be sourced from stem cell banks. The EPO’s decision should therefore allow patents to be granted for hESCs where a stem cell bank rather than an embryo is identified in the patent as the source, despite the fact that at some stage an embryo may have been destroyed in order to produce the cell line.
The UKIPO’s position has been that inventions using stem cells not capable of forming a human being were patentable irrespective of their source. In March 2009, following the EPO ruling, it confirmed that it would continue to grant patents for such stem cells as long as it can be demonstrated that, at date of filing, the invention “could be obtained by means other than the destruction of human embryos”.
It remains to be seen whether other EU countries will adopt similar policies and uphold patents granted by the EPO, but they will come under increasing pressure to do so. Although there will always be ethical concerns about use of human embryos in medical research, the debate in this area has progressed significantly in the last decade, primarily because of the great potential to find cures for debilitating conditions.
Europe has established a reputation for stem cell research largely as a result of its relatively open attitude towards investment and likely patent protection, but the necessary significant funding will only be forthcoming if investors know that they will be able to reap the financial rewards of their work. And this means allowing them to protect their work through patents which can be enforced consistently throughout Europe.
Now that the US has started to dismantle its barriers to investment in stem cell research, Europe needs to get its act together – and quickly – before it loses funding and research capability, together with its competitive advantage, to the US.