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May 17, 2011

Stem cell technology development gets cold shoulder from European Advocate General

by Paul Krzyzanowski

Protecting inventions arising from publicly funded research is a polarizing issue for many scientists and the general public. One perspective views all the fruits of publicly-funded research as public domain, while another believes that same knowledge must be turned into products by entrepreneurship and private sector investment. It’s a tricky dilemma with no clear answer. In the stem cell research field, problems of ethics complicate matters further, particularly when it comes to human embryonic stem cells. 

In Europe, the Advocate General M. Yves Bot recently released a recommendation for a legal ruling that may result in severe restrictions on patentability of inventions using human stem cells.

Naturally, the research field opposes such restrictions on research and the implementation of knowledge. An open letter was recently published in Nature (Also available here for Open Access) and the ISSCR has also made a statement on this matter. For those interested, the European Advocate General’s nearly 8000-word Opinion Statement is available online, in addition to the European Court of Justice’s press release.

In summary, recommendations are being put forward to apply the term ‘human embryo’ to all stages in which totipotent cells can be found, beginning from fertilization and including the blastocyst. Totipotent cells created from somatic cell nuclear transfer are included in this definition. So too are inventions that use pre-existing embryonic stem cells – the Advocate General’s opinion equates inventions using embryonic stem cells to an industrial application that uses human embryos as a base material (which scientifically isn’t really the case), and thus considers them completely unpatentable.

If the Advocate General’s recommendations are passed into European law, it will dissuade, but not prohibit, European companies from investing in stem cell technologies. It’s important to keep this distinction in mind. A prohibition on patenting leads to the denial of intellectual property protection, not the prevention of the activity itself.

The effect on European stem cell companies would be to reduce investment into products that require patent protection to be economical. Productization of embryonic stem cell-based tools, like drug toxicity assessment technologies, might stall not only within Europe, but worldwide.  The European market isn’t isolated and potential revenues from the region are often incorporated into predictions of returns when investors decide whether to sponsor a project or not. 

The ultimate effects on academic research are a little more difficult to predict. Insofar as academic pursuits become more intertwined with industrial goals and patenting activity, should it become more difficult to obtain IP protection for potential stem cell technologies, researchers may choose to pursue projects with less career uncertainty.

While Advocate General Bot’s recommendation tries to solve the ethical problem of obtaining human stem cells on a large scale, it takes an indirect approach that will eliminate financial incentives for human cell-based technology development.  It may completely freeze some technologies that have been demonstrated academically, but have yet to find the investment needed to run clinical trials. Those in the stem cell field are left in a quandary:  you can develop the technology, but it may never be commercialized and used.


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