This conclusion, which runs counter to the views of the European Group on Ethics (EGE) under the European Commission, was reached by an interdisciplinary group involving ethics researchers Mats G Hansson and Gert Helgesson at the Centre for Bioethics at the Karolinska Institute; Richard Wessman at the Department of Law, Uppsala University; and one of the world’s leading stem cell researchers, Rudolf Jaenisch at the Whitehead Institute for Biomedical Research and the Massachusetts Institute of Technology.
“Our conclusion is that, in principle, stem cells can be patentable and that this is consonant with ethical views that the human embryo should enjoy special protection owing to its capacity to develop into a human being,” says Hansson.
The possibility of patenting stem cells has been excluded by several bodies, including some national European patent authorities and the EGE. According to the EGE, only genetically altered stem cells or cells that have been further developed into certain body parts should be eligible to be patented. In several European countries patents for stem cells have been ruled out, while the European Patent Organisation, along with several national patent offices, has a wait-and-see policy.
“It was when I understood that people have failed to grasp that the great challenge in stem cell research lies in taking the first step – to succeed in getting the cells to survive in a culture medium – that I got the idea for the article. If the cells survive, it will be in a form that is completely different from their origin, so they should be patentable,” says Hansson.
The survival challenge
The great challenge for stem cell scientists is thus not primarily to alter embryonic stem cells genetically, or in some other way. The difficult scientific and technological task is to get these cells to survive in a laboratory environment in the first place, outside the blastocyst cells they were taken from.
To develop stem cells entails a radical modification that is achieved by altering the various environmental factors that make the cells grow – changes that irreversibly break down the protective protein casing that surround the cells’ DNA. A cell isolated from a human embryo is therefore crucially different from what it originally was.
The researchers conclude that isolated stem cells should be eligible for both method and product patents as long as the research meets accepted patent requirements, such as degree of invention and industrial application.
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