The patenting of nature, particularly when relating to human life, is a question heavy with legal, moral and emotional baggage. When it comes to stem cell-based therapies, these issues revolve around consideration of the human embryo. In 2011, the Court of Justice of the European Union drew the line between acceptable business and treading on human dignity very strictly in favor of protecting all possible embryos. In doing so, it may have overstepped its role and will certainly have an impact on future research in the stem cell field. Following his presentation of promising results at the Biovision World Life Sciences Forum, stem cell scientist Oliver Brüstle commented on his own fight to patent such work.
(Flickr / opensourceway)
While the US Supreme Court was busy last week hearing arguments over the patenting of human genes, Europe saw another episode in a long-running biotech patent drama. On April 11th, the European Patent Office (EPO) ruled against a patent, originally granted in 2006, involving human embryonic stem cells.
Oliver Brüstle, neuroscientist and director of the Institute of Reconstructive Neurobiology, in Bonn, Germany, had patented a technique he developed for transforming human embryonic stem cells (ESC) into neural precursor cells. These precursors are able to develop into mature neurons and may have applications for regenerative medicine, replacing missing or dysfunctional cells in diseases like Parkinson’s and Huntington’s. Professor Brüstle feels patents are essential in this field to ensure the private investment necessary for the development of therapeutics.
In 2004, Greenpeace brought a lawsuit against Brüstle, on the grounds that his patent violated public policy and accepted principles of morality. The trouble, they said, is that the stem cells used in Brüstle’s method are originally obtained through a process involving destruction of a human embryo. And patenting such a process for “commercial or industrial purposes” is specifically banned by Article 6 of the European Directive on the legal protection of biotechnological inventions.
Today, methods do exist for obtaining ES cells without destroying an embryo (as part of preimplantation genetic diagnosis, for one), but, as this was not the case at the time the application was filed, they cannot be considered in the patent request. Furthermore, the patent in question covered a downstream process that uses established embryonic stem cell lines, never the human embryo itself.
Nevertheless, the German Federal Patent Court ruled that Brüstle’s patent violated European law on this point. “Normally, patentability is judged by looking at the patented composition or procedure, not at preceding steps,” Brüstle explains. “This has never happened before. This is an indicator case that will have an impact on many other patent applications. It’s just the tip of the iceberg.”
When he appealed this decision, the German courts referred questions on ambiguous wording in the biotech directive up to the European level. In October 2011, the European Court of Justice ruled that a patent such as Brüstle’s must fall under this category of unpatentable stem cell techniques. (A decision that affected all European patents: According to Brüstle, there are more than 100 in the UK and Sweden that are now of no value.)
Significantly, what the Court did was interpret the European directive as intending to provide full legal protection to all human embryos, using a very broad definition. Now, any human egg ovum that, through either ordinary fertilization or manipulation through lab techniques, is capable of continuing development must be accorded the same protection under the law. This protection excludes from patentability any technology that arrives farther down the line, if an embryo was destroyed at any previous step.
Aurora Plomer, professor of law and bioethics at Sheffield University, writing in the Guardian, took issue with this decision on legal grounds. It pays no heed, she said, to the plurality of views that exist in Europe. The Court assumed a consensus on questions of morality pertaining to human embryos, which simply does not exist.
“What is remarkable,” Oliver Brüstle adds, “is that normally patent law is not supposed to touch on questions like What is life? and How do we protect it? These values we have in society are typically covered and protected by much broader legal regulations such as constitutional law.”
Although the European stem cell patent was struck down, Germany’s Supreme Court recently took a less restrictive view, ruling that patents involving human ES cells can be granted, provided that the patented procedure does not involve prior destruction of an embryo. This means that Oliver Brüstle’s technique for creating therapeutic neural precursor cells, and others like it, could still be patent-protected in Germany with an appropriate disclaimer.
With its April 11 decision, the EPO has closed this narrow window opened by the Supreme Court, adopting again a very restrictive position. “It is disappointing to see that the EPO handles the case more restrictively than the Federal Court of Justice”, says Brüstle. “This office is supposed to support inventors. But when it comes to sensitive topics in biotechnology, fear of environmentalist organizations seems sometimes to be bigger than striving for forward-looking decisions”.
The impact this patent dispute will have on stem cell-based innovation is up for debate. Patent lawyer George Schlich wrote in a plea to the EU Court of Justice that “if this view prevails, it is…another disincentive to invest in development in Europe of stem cell-based therapies.” But for Chris Mason, a professor of regenerative medicine bioprocessing at University College London, “the reason patents like this are important is not commercial. If pro-life lobbies could make embryonic stem cell technologies unethical to be patented, then they could push on and say the research itself is unethical.” Certain members of the European Parliament, for example, have sought to cut funding for embryonic stem cell research from the Horizon 2020 funding program.
The question is far from resolved: opinions on ES cell research continue to divide Europe and Oliver Brüstle plans to appeal the latest rejection of his European patent. In the meantime, the most important thing stem cell scientists can do is make certain to communicate with the public about their work, its background, methods and goals, to dispel some of the confusion that tends to cloud this promising field.
Find out more:
Video of Oliver Brüstle’s presentation at the Biovision World Life Sciences Forum
Oliver Brüstle's research focus at the Institute of Reconstructive Neurobiology
Stem cell patents: legal aspects
“The Brüstle-Patent-Case - Legal Background and Impacts to European Stem Cell Research and International Cooperation”, a presentation by Timo Faltus, Legal Researcher, Leipzig University
EuroStemCell, Europe's stem cell hub
Research intelligence - Continental rift over stem cell research