The Court of Justice of the European Union (CJEU) recently handed down judgment on whether stem cells obtained from parthenogenetically stimulated human ova are excluded from patentability as “human embryos”. Since the Brüstle decision in 2011 , the position has been that that stem cells obtained from human embryos whether directly, or indirectly, are unpatentable. However, following the CJEU’s recent decision in International Stem Cell Corporation v Comptroller General of Patents the position appears to have changed.
Embryonic stem cell research has been a controversial topic since its inception in the late 1990’s when James Alexander Thompson developed the first embryonic stem cell lines at the University of Wisconsin. Stem cell technology is thought to hold the key to some of the most innovative treatments of our generation but research has often been curtailed by questions of moral and ethical considerations.
Approach to stem cell research throughout the world
There are a wide variety of sources commenting on the approach to stem cell research throughout the world. It is reported that Asia is at the forefront of stem cell research and Singapore is the “Asian stem cell centre” with over 40 stem cell research groups. Research is authorised for therapeutic purposes on embryos no more than two weeks old.
In China, it appears that research has progressed without much legal interference and it has some of the most relaxed policies in the world (this is arguably connected to the Chinese cultural notion that life begins on birth) and Japan allows stem cell research for therapeutic purposes (although there are no formal guidelines).
Commentary suggests that South Korea has made strong advancements in stem cell research because of its flexible policies regarding research which have propelled South Korea to the forefront of stem cell research. Stem cell lines have been produced that are a perfect genetic match to patients of all races and genders.
Australia has a relatively liberal approach allowing research on cloned embryos for therapeutic purposes but on the condition that they must be discarded within 2 weeks. There is still a blanket ban on cloning for reproduction which is the common position worldwide.
The Brazilian government passed controversial legislation in 2005 allowing excess in-vitro-fertilisation (IVF) embryos frozen for more than three years to be used in research.
Mexico has no formal regulations and stem cells are being used to treat locals and foreigners for conditions such as cerebral palsy and autism and apart from the moral arguments, however the international community have criticised this lack of regulation.
US legislators face the difficulty of unifying policies that govern divided opinions between states. It has dealt with this by limiting federal funding for embryonic stem cell research to a small number of stem cell lines and allowing private funding and funding at state and local levels.
So what about the EU?
Opinion within the European Union (EU) has historically been divided. Germany, Austria, Italy, Finland, Greece, Ireland, Portugal and the Netherlands have traditionally taken a more restrictive approach. On the other hand, Sweden and Belgium, along with the UK, support embryonic stem cell research.
The UK (under the the Human Fertilisation and Embryology Act 2008) permits the destruction of embryos for human embryonic stem cells and authorises Somatic Cell Nuclear Transfer . This is on the proviso that these acts are done in order to increase knowledge about the development of embryos or serious disease.
The EU enacted the Biotechnology Directive (“Directive”) in 1998 in order to bring about harmonisation in relation to the approach to legal protection of biotechnological inventions. Under the Directive, inventions based on the use of human embryos for industrial or commercial purposes could not be patented on moral grounds . This left many questions open as to whether the meaning of “human embryos” included stem cells derived from human embryos and if methods derived from human embryonic stem cells were patentable.
This ambiguity was enough for differences to appear in the application of the Directive by the different patent offices and the UK saw 100 patents for human embryonic stem cell inventions granted by 2009 whilst in Germany the Federal Patent Court refused to grant them.
The Court of Justice of the European Union (CJEU) considered the ambiguities of stem cell patentability in the Brüstle case. In this case, the CJEU determined that “use of human embryos for industrial or commercial purposes” included scientific research and this effectively banned patents for embryonic stem cell research. It was a decision condemned by medical researchers and those who believed stem cell research capable of revolutionising medical treatments.
The latest position
The question of human parthenote patentability has however recently been thrust back into the spotlight in the recent International Stem Cell Corporation case.
On 18 December 2014 the CJEU made a crucial distinction between embryonic stem cell technologies based on fertilised human ovum and those based on unfertilised human ovum stimulated by parthenogenesis. The court held that unfertilised human ovum stimulated by parthenogenesis does not constitute a “human embryo” within the meaning of the Directive and as such unfertilised human ovum stimulated by parthenogenesis were patentable.
The technology at the centre of the dispute used parthenogenetic activation of oocytes and so did not involve the destruction of a fertilised ovum capable of developing into a human being. The case concerned two patents for technology that produced stem cell lines and corneal tissue from the parthenogenetic activation of an unfertilised ovum.
It was common ground in the case that such parthenogenetically-activated ova did not produce totipotent stem cells , but instead pluripotent cells , and were therefore not capable of developing into a human being.
The ruling will no doubt open the door for other patent applications using similar methods and may open up arguments that other research methods are also patentable. It is important to note that the CJEU specifically flagged that parthenotes which have been the subject of manipulation by genetic engineering fell outside the remit of the case, which strikes a warning to those considering inventions which involve such activity.