EU High Court Bans Patents On Human Embryo Stem Cells For Commerce

The European Union high court today outlawed the patenting of human embryo stem cells for scientific research or commercial purposes. The decision has forced European courts to examine the “ethical boundaries of patenting,” said Greenpeace, which challenged a German patent in the case. While there are alternate methods for obtaining stem cells, the ruling will nevertheless affect some research, one patent lawyer said.

The case arose from a 1997 patent granted to Oliver Brüstle relating to isolated and purified neural precursor cells, processes for producing them from embryonic stem cells and use of the neural precursor cells for treating neural defects such as Parkinson’s disease, the European Court of Justice (ECJ) said. Greenpeace challenged the patent in the German Federal Patent Court, which ruled the grant invalid. Brüstle appealed to the Federal Court of Justice, which asked the ECJ to interpret the concept of “human embryos” and “uses of human embryos for industrial or commercial purposes,” and to determine whether exclusion from patentability of human embryos covers all stages of life from fertilisation.

The ECJ defined “human embryo” as “any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis.” It said “uses of human embryos for industrial or commercial purposes” also cover use for scientific research, unless that research is for therapeutic or diagnostic purposes applied to the human embryo.

The high court said further that an invention cannot be patented where the technical teaching that is the subject matter of the patent application requires the prior destruction of human embryos or their use as base material, at whatever stage that takes place and even if the description of the process claimed does not refer to the use of such embryos. The decision is here.

Greenpeace welcomed the ruling, saying the ECJ has strengthened the protection of human life against commercial interests within the EU. The European Patent Office has not granted patents on human embryonic stem cells since 2006, and national patent offices which still award such patents must now change their practices, it said. The decision will only affect some stem cell research because there are now alternative ways to obtain such cells without destroying human embryos, it said.

The decision will lower the incentive to use human embryonic stem cells and boost the use of alternative stem cells, Greenpeace patent campaigner Christoph Then said in an interview. However, the ruling could affect some research, particularly in the UK and Sweden, where patents are being sought on the basis of human embryos, he said.

Greenpeace decided to get involved in the issue because of concerns over the European patent directive, a law that allows “grabbing” of food and other resources, Then said. Since the measure does not define human embryos, the organisation sought clarification as a means of stopping the patenting of lives, plants, animals, he said.

One of the most controversial aspects of the decision is that an invention is unpatentable even if its purpose is not the use of human embryos, when it concerns a product whose production necessitates the prior destruction of human embryos or a process which requires a base material obtained by destroying human embryos, said Mewburn Ellis LLP (Cambridge, UK) Patent Partner Hilary King. This is particularly relevant to areas of stem cell research that use stem cell lines originally obtained by destroying human blastocysts, which can now be maintained in culture and used without destroying more embryos, she said.

The court’s statement that the fact that embryos were destroyed long before the invention was implemented is irrelevant “could be interpreted to rule out patentability of inventions that rely on embryonic stem cell lines as a base material, even if the step of destroying human embryos to create that base material was in the distant past,” King said.

But the ECJ didn’t necessarily mean to bar inventions that rely on renewable cultured stem cell lines from patentability, she said. “If an invention can be practised by using deposited human embryonic stem cell culture, it could in principle be patented at the European Patent Office,” she said.

Other stem cell work and research uses adult human cells induced to become pluripotent so they can develop into different human cell types but not into human embryos, King said. Since those lines of research do not involve human embryos or require their destruction, they could be patented under the ECJ interpretation, she said.

Some current research still relies on human embryonic cells but the need for them has lessened as cultured cells have become available, King told Intellectual Property Watch. The ECJ ruling is “nevertheless relevant to those working with human embryonic stem cells in the EU, including blue skies research as well as research into stem cell therapies,” she said.

Intellectual property rights protection is critical to all branches of medical research, including human embryonic stem cell research, the International Society for Stem Cell Research said in April in response to an opinion by ECJ Advocate General M. Yves Bot which recommended the ruling now adopted by the court. Excluding products or technologies based on such research from IP protection “will preclude investment in potentially life-saving treatments, and curtail the engagement of both publicly and privately funded stem cell research,” it said.

[Update] Human embryo cells have two very important characteristics which make them suitable for treating degenerative diseases, Professor Sir Ian Wilmut, of the MRC Centre for Regenerative Medicine at the University of Edinburgh, said on behalf of the ISSCR. In appropriate cultures they multiply for very long periods while retaining the ability to form all of the different body tissues, he said. That is why academic research laboratories and companies around the world are carrying out research with the aim of using them in cell therapy, he said. There are two clinical trials in progress now, he said.

The research needed to make the initial discovery of how to produce a specific type of cells is just the beginning of what is required, Wilmut said. Research is often supported by pharmaceutical or biotech companies who may now be reluctant to get involved because they will not be able to protect their method, he said. That could cause funding from national and European government agencies to dry up, he said. And in the longer term, “the people who will suffer most are the patients who may now have to wait longer for their treatment,” he added.