Human embryos; a collapsing market?
When compared to other countries, European researchers in the field of human embryonic stem cells maybe at a disadvantage. Because of the morality clause in the European Patent Convention, the EPO does not grant patents on human embryonic stem cell research.
Human pluripotent stem cells
Embryonic stem cells are obtained from an undifferentiated inner mass of cells from a human embryo. Such cells are pluripotent and so are able to differentiate into any types of cells the human body is able to produce. Since the 1990s, research regarding stem cells has been a very controversial discussion. On the one hand, there are hopes and potential in the area of regenerative medicine and therapeutics (for instance the development of human embryonic pluripotent stem cells into tissues of organs), which would have obviously beneficial effects to society. On the other hand, ethical concerns arise when human embryos have to be destroyed in order to obtain the embryonic pluripotent stem cells which are needed.
Article 53 of the EPC (European Patent Convention) states that patents will not be granted in respect of inventions, of which the exploitation or publication would be contrary to ordre public or morality.
Although there are several ethical concerns, stem cell research is well developed within Europe. There are several legal provisions such as Regulation (EC)1394/2007 Advanced Therapy, Medical Products) and the Directives 2004/23/EC and 2001/83/EC which permit the use of embryonic stem cells of humans in a controlled manner, but leave it for national legislation to prohibit such use. Article 5(1) of the 98/44/EC Directive on Biotechnological Inventions excludes the human body, in whole or in parts, at various stages of development from patentability. In addition, Article 6(2)(c) of the Directive excludes the use of human embryos for industrial and commercial purposes as being against ordre public and morality. As a result, any use of human embryos for industrial and commercial purposes cannot be patentable. However, Article 5(2) allows the patenting of elements isolated from the human body or produced by technical means.
Non-patentability of human embryonic stem cells
The patenting of living organisms is thought to have begun in 1873 by Louis Pasteur and his isolated yeast, 10 years before the introduction of the Paris Convention. Since then, technology has been constantly improving and patentability of living organisms has been declining due to emerging ethical and moral concerns.
In 2008, the Enlarged Board of Appeal (EBA) held that inventions regarding human embryonic pluripotent stem cells are against ordre public or morality, even when the product is intended to be used for further research. It also reiterated that “this use involving destruction [of human embryos] is thus an integral and essential part of the industrial or commercial exploitation of the claimed invention and thus violates the prohibition of Rule 28 (c) EPC.”
As a result, inventions that involve human pluripotent stem cells cannot be patented under the EPC, even if they have been generated under compliance with the applicable regulatory provisions of each country.
Problems regarding the European approach
As patents are thought of as being a major incentive for investment in pluripotent human stem cells for therapeutics, such investment began to collapse in Europe and take place outside the European Union as they are excluded from patentability and their incentive was taken away. As a result, Europe was found to be at a disadvantage as compared to other countries such as the US and China in being rewarded for research in stem cells. In recent years however, as technology has improved and is capable of obtaining embryonic stem cells non-destructively from human embryos, the previous restrictions do not apply to such new methods and researchers can begin to obtain patents over stem cell research through this window.
Even with new methods, the dilemma between stimulating innovation in the biotechnology industry within healthcare through patents on the one hand, and respecting the basic legal and core principles of human integrity and dignity on the other hand is still not balanced. In 2014, in the case of International Stem Cell Corporation v Comptroller General of Patents, the court confirmed that a human embryo at any stage is not patentable. However, according to the Court, a process that develops organisms that cannot further develop into human beings, should be patentable within Europe. The Court concluded that “unfertilised human ovum whose division and further development to a certain stage have been stimulated by parthenogenesis, does not constitute a ‘human embryo' under European Union law”. Hence, such products can be allowed for patenting and commercialisation. Although this may have given a brief relief to people involved, it is still unknown if such an approach along with the ‘stem cells obtained non-destructively’ approach will be future proof, certainly when considering the increasing potential and abilities of genetic manipulation techniques.
|Written by Andreas Rossos - IPKM student 2018/19 - More blogs on Law Blogs Maastricht|