ECJ Stems “Stem Cell” Patents
The sticky nature of Biotechnology research has always led to massive debates every time there was path-breaking discovery. It happened with Nucleic acids, amino acids, genetic modifications, transgenic animals and now stem cell research. This has been mainly because of its close and unavoidable link to life. When we came to believe that stem cell therapy for all monstrous ailments is around the corner, the moral police made its presence felt. After the famous WARF patents in US, it is now the turn of University of Bonn in Europe. On 18th of October in the Oliver Brustle v. Green Peace case; the ECJ gave its verdict on Patentability of Embryonic Stem cells in negative. In November 2009, Green Peace sought to prove in the German Federal Court of Justice that a patent held by Oliver Brustle, a University of Bonn professor was unlawful. Mr. Brustle’s patent was related to isolated and purified neural precursor cell and the process of producing the same from embryonic stem cells. In the German Court, Green Peace had argued that Brustle’s therapy contravened Article 2 of the German Patent Act, which prevents the grant of patents on any usage of human embryos in an industrial or commercial context. To this, Mr. Brustle countered that the embryos used in his research were created in laboratory conditions and the use of such embryos was being made only for research purposes. (I wonder why he would want to invest in filing for a patent when all he wants to use the patent for is research!)To this, the German court had stated that although the aim of scientific research must be distinguished from industrial or commercial purposes, the use of human embryos for the purposes of research which constitutes the subject matter of a patent application cannot be separated from the patent itself, and the rights attaching to it. In that regard, the use of human embryos for purposes of research that is the subject matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability.
The Federal Court of Justice, Germany decided to refer questions to the European Court of Justice concerning the interpretation of, in particular, the concept of ‘human embryo’ which is not defined in Directive 98/44/EC on the legal protection of biotechnological inventions (Biotech Directive).
The European Court of Justice (ECJ) analyzed the question in the light of TRIPS and the Biotech directive and stated that “any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’”.
As per Article 6 (2)c of the directive use of human embryos for industrial or commercial purposes shall be considered as unpatentable.
To summarize, any patent relating to embryonic stem cells that requires one to destroy a human embryo (irrespective of whether it is taken from a female womb or prepared in a Petri dish) will be considered non-patentable irrespective of whether the said use is in the industry or for research.
Although I’m an absolutely pro-patent person, I agree with the ECJ decision to a large extent. This is not because I think the destruction of an embryo for research purpose is immoral and is a threat to women (remember the hilarious debate within the EU where it was argued that embryo patent would lead to slavery of women! It was so cinematic that I rolled on the floor laughing for hours.)
In my opinion, Stem cell therapy research at present is not very developed. If the story stem cell researchers are selling regarding its benefits are to be believed, it has the potential to change the entire approach of the health system. As it stands today, although in theory stem cell treatment sounds possible, there are several practical challenges that the researchers are facing to make the treatment work (eg. issues relating to transporting the stem cells to the affected area, controlling its multiplication, sustaining its effects etc). Given its potential, if patents are granted at this stage, it would create a “tragedy of anti-commons” kind of situation and would dissuade others from actually working on overcoming the existing challenges. This, in turn, would hinder the progress of stem cell research thus defeating the purpose of patents itself. In an ideal world, stem cell research should be public funded until such time that enablement and safety issues are sorted out. What is your take on it?
Contributed by Vinita Radhakrishnan