The European Union (EU) Court of Justice ruled today that any process that removes stem cells from a human embryo where it
entails the destruction of that embryo cannot be patented. The ruling has led to speculation that it will hamper the development of therapeutic stem
cells and drive investment to the US and other countries.
The EU Court of Justice, which has headquarters in Luxembourg, interprets EU law to make sure it is applied in the same way in all EU countries.
Why the Ruling?The German Federal Court of Justice had asked the EU court to provide an interpretation of the concept of "human embryo" to help it deal with an appeal by Mr Oliver Brüstle, a German scientist whose patent on an invention to create nerve precursor cells from human embryonic stem cells was ruled invalid by the German Federal Patent Court.
Brüstle's method requires the removal of stem cells from a human embryo that has reached the blastocyst stage (around day 5 after the egg has been fertilized). The stem cells would then be used to treat neurological diseases, and according to information Brüstle supplied to the court, there are already clinical applications, particularly for patients suffering from Parkinson's disease.
The German federal court sought the interpretation because the relevant EU Directive (number 98/44/EC, concerning the legal protection of biotechnological inventions) does not define the term "human embryo".
The ruling itself constitutes three parts: the definition of the term "human embryo", whether scientific research is covered in the same way as commercial or industrial application, and whether an invention involving the production of neural precursor cells would be covered.
What Is An Embryo?A press statement about the ruling says the EU court decided to interpret "human embryo" in its widest sense, because the aim of the Directive is to "exclude any possibility of patentability where respect for human dignity could thereby be affected".
So they ruled that essentially the term "human embryo" covers a fertilized human egg from the point of fertilization onwards, "if that fertilisation is such as to commence the process of development of a human being".
They pointed out that it was up to the ruling court to decide if, "in the light of scientific developments", whether stem cells obtained from a human embryo at the blastocyst stage are capable of "commencing the process of development of a human being and, therefore, are included within the concept of 'human embryo' ".
Scientific Research Not Distinct from Commercial or Industrial UseThe court decided that the "use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability".
They explained that the grant of a patent for an invention "implies, in principle, its industrial or commercial application", and therefore, although scientific research has different aims to industry and commerce, using human embryos for research that is subject to a patent application "cannot be separated from the patent itself and the rights attaching to it".
However, the court also points out that the Directive does not forbid patents on the use of human embryos where that use is "therapeutic or diagnostic" and is useful for the embryo, for instance to correct a defect and improve the chances of life.
Neural Precursor Cell PatentsIn answering the question of whether patents for inventions involving the production of neural precursor cells should be allowed, the court decided that they should not, because this presupposes two things: these types of stem cells have to be removed from the human embryo at the blastocyst stage (and this is after fertilization), and their removal destroys the embryo.
They added this third point because a skilfully drafted patent application could be written in such a way as to avoid mention of human embryos.
In other words, the court holds that an invention should not be patentable if the process it describes requires that human embryos are destroyed either directly, or in order to produce the base material, even if the patent application does not refer to the use of human embryos. It looks like this third part of the ruling was made because Brüstle's application apparently does not mention human embryos.
What Might Happen to Stem Cell Research in Europe?There has been speculation that the ruling may drive stem cell research and investment outside the EU.
But there also those who say this will not happen, because the ruling is only about patents: it is not outlawing the research per se, just the ability to patent it and there are other ways to protect scientific methods, plus there are other ways to make stem cells (although not necessarily as safe or effective as embryonic ones).
Richard Willoughby, an intellectual property lawyer writes in The Telegraph today there are positive and negative aspects to the ruling. Among the positives he says that removing patent protection could actually free up early stage research in the EU and make it more attractive.
Among the negatives he says the absence of patent protection could make it harder for companies and research institutions in Europe to get funding, and this could shift investment to other places like the US.
On balance, Willoughby suggests the negatives will outweigh the positives, and "there is a risk that this will hinder the development of therapeutic stem cells, which have shown immense promise for treating some of the most problematic medical conditions".
Click here to read the full text of the ruling.
Written by Catharine Paddock PhD