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European Biopharmaceutical Review

Stemmed Potential

Stem cell research is in its infancy, and if companies are to invest in costly and long term research they need some protection for their investment. A recent ruling in Europe on patents that make use of human embryos could have a detrimental effect on future research and developments.

A recent legal decision from the Court of Justice of the European Union (CJEU) has decided that inventions which make use of human embryos are not patentable on morality grounds. While the decision has been welcomed by Greenpeace and some church groups, many scientists have expressed deep concern about the detrimental effect that this decision may have on the stem cell industry within Europe. The decision highlights the complex relationship between science, law and ethics that have to be taken into account when patenting inventions in the area of human embryo research.

The issues stem from the requirement in European patent law for the commercial exploitation of an invention not to be “contrary to morality”. For many years, the European Patent Office (EPO) examiners had very little guidance on what inventions were immoral; the example usually given was that of a letter bomb – an object with no moral use. In 1998, however, the European Commission passed a directive on the patenting of biotechnological inventions (generally known as the Biotech Directive, EC/98/44). The main aim of this directive was to confirm that various biotechnological inventions were patentable, such as isolated genes, purified proteins and isolated cells (even if such genes, proteins and cells are present in non-isolated or non-purified form in the human body). The directive also included – for the first time – a list of inventions which were said to be immoral and hence not patentable. This list included inventions which concern “uses of human embryos for industrial or commercial purposes”. At the time that the directive was passed, stem cell technology was in its infancy and hence the directive did not directly address the patentability – or morality – of human stem cell based inventions. Although it was not obliged to do so (the EPO is not an EU institution and hence is not bound by EU law), the EPO implemented most of the provisions of the Biotech Directive into its rules in 1999.

Since that time, stem cell technology has developed rapidly and stem cells have been shown to have great potential in treating numerous disorders such as Alzheimer’s and Parkinson’s diseases, and to be capable of providing a ready supply of specific cell types which can be used to repair or rebuild organs such as hearts. However, the original source of human stem cells is the human embryo (and this is generally still considered to be the best source, despite other sources of stem cells now having been found). Human embryonic stem cells are obtained from four to five day old human embryos, and the removal of these cells leads to the death of the embryo. These stem cells are called pluripotent stem cells because they have the capacity to form almost all of the cells within the human body, but they cannot individually form an entire human being. For this reason, it had generally been accepted that patents claiming such cells fall outside of the ‘uses of human embryos' exclusion.

The first time that this ‘uses of human embryos’ rule was tested was in 2008 when the European Patent Office (EPO) was asked to rule on the morality of a patent application filed by Wisconsin Alumni Research Foundation (WARF) related to pluripotent human stem cells. In that case, the EPO decided that, although the claims of the patent application did not specifically cover ’uses of embryos‘, at the filing date of the patent application, human embryos had to be destroyed in order to produce the claimed pluripotent stem cells, and hence the invention could not have been put into practice at that time in a moral manner. For that reason, the WARF patent application was rejected by the EPO under the morality exclusion. Since that time, however, it has been the practice of the EPO to allow patents on human stem cell inventions under circumstances where the inventions can be put into practice without requiring the destruction of human embryos, for example if the inventions are based on established human stem cell lines which have been grown in the laboratory.

The latest decision from the CJEU looked at similar issues to those considered by the EPO; that is, whether pluripotent stem cells can be patented. In this case, a German patent had been granted to Professor Brüstle which claimed pluripotent human neuronal cells but, just as in the WARF case, the pluripotent stem cells had to be obtained from human embryos. The German patent was challenged by Greenpeace, who alleged that the invention fell within the ‘uses of human embryos’ morality exclusion. The German courts decided to ask the CJEU to provide a definition of a ‘human embryo’ and to provide guidance on how the term ‘uses of human embryos for industrial or commercial purposes’ should be interpreted. Many people expected it to provide similar answers to those that were given by the EPO.

However, an early indication that the CJEU was going to depart from the WARF decision was provided by the Advocate General in March 2011 (the Advocate General is a legal advisor to the CJEU who provides a preliminary opinion on the issues before the court. This preliminary opinion is usually followed by the full court in its final decision). In this case, the Advocate General provided his interpretation of what was meant by the term ‘human embryo’, and confirmed that Brüstle’s pluripotent stem cells did not fall within this definition. However, he then hinted strongly that the full history of the invention needed to be considered when judging its morality. Hence, in his opinion, even if the invention could be put into practice at the filing date of the patent application by using laboratory-grown stem cells, the fact that those cells – at some point in their history – would have been obtained from a human embryo meant that the invention fell within the morality exclusion. It is this latter assertion that sent shockwaves through the European stem cell industry earlier last year, with letters of concern being published in Nature and the major UK newspapers.

Despite intense lobbying, the fears of the stem cell companies were realised in October when the CJEU agreed with the opinion given by the Advocate General, stating that “The fact that destruction [of the human embryo] may occur at a stage long before the implementation of the invention ... is irrelevant.” Hence the CJEU has essentially said that if an invention makes use of a human embryo or makes use of material obtained from a human embryo – at any point in its past – then that invention will be unpatentable in Europe on morality grounds.

The decision of the CJEU is binding on all of the courts of the member states of the EU. Existing European patents which cover such inventions will still remain in force until they are challenged, but they will become essentially unenforceable. Patentees will have to take decisions on whether such patents still have any residual value, or whether they should simply be allowed to lapse due to non-payment of renewal fees.

The CJEU decision is not in fact binding on the EPO (because, as mentioned above, the EPO is not an EU institution). The EPO is already, however, taking steps to change its examination practice to bring it into line with the decision because they recognise that it would be inappropriate if the EPO were to grant European patents which were then not valid in the member states of the EU. The UK Intellectual Property Office is also considering how its practice needs to be changed in light of this decision. The decision will have no direct effect on the patent practices of non-European countries, although it might well be influential in determining patent policy in some other countries.

With regard to the commercial effect that this decision might have, some have expressed concern that European stem cell companies will move to the US or Asia if they receive reduced investment and support within Europe as result of this decision.

The decision does not affect the patentability of other areas of stem cell research, such as adult human stem cells, non-human stem cells or induced pluripotent stem cells (iPS cells). However, it would be unfortunate if humanity were to be deprived of the (potentially large) benefits of human embryonic stem cell research merely because of the unavailability of patents.

It is interesting to speculate whether patents in other areas of technology might be vulnerable as a result of this decision. Does the use of slave labour to mine metals such as tin, tantalum, tungsten and gold for the mobile phone industry mean that mobile phone patents are immoral?

It is rather ironic that the recitals of the Biotech Directive acknowledge the fact that “the protection of biotechnological inventions will certainly be of fundamental importance for the community’s industrial development” and that “only adequate legal protection can make them profitable,” whereas it is the rules of this same Biotech Directive which may in fact lead to significant damage to the fledgling European stem cell industry. Or is the decision a timely reminder that, whatever the benefits that stem cell technology might hold, we must not lose track of our sense of morality or respect for human dignity?

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Philip Webber is Partner at Dehns Patent and Trade Mark Attorneys. Phillip prosecutes patent applications in all areas of molecular biology and biochemistry including genomics, proteomics, recombinant DNA and protein products, biosimilars, transgenic plants and animals, stem cells, diagnostics assays, virology and vaccines. He is also an active member of the Life Sciences Committee of the UK Chartered Institute of Patent Attorneys (CIPA) and often gives presentations to university students and academics, as well as training junior patent attorneys. He has spoken at many European and UK conferences and on BBC Radio about the patenting of biological and biotechnological inventions, and has published a number of papers in this area. Email:
Philip Webber
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