There has been concern for months about the direction that the European Union was heading in regards to intellectual property (IP) rights and stem cell patent approaches.
Now, a definitive decision banning embryonic stem cell (ESC)-based patents by the EU Court has dealt a severe blow to stem cell science in Europe.
The European Court of Justice ruled today that methods involving not just human embryos but also existing human ESC lines, cannot be patented. Remarkably, this ruling impacts all 27 members of the EU.
What this means is that in one fell swoop the Court has eliminated the incentive for biotech and big pharma companies from investing in ESC-based research essentially in all of Europe. In turn, this means that translating ESC-based research to the bedside for cures will be nearly impossible.
While some lawyers quoted in the piece talk about potential work-arounds to allow for protection of IP for some ESC-related methods, the bottom line is that this ruling has nearly completely frozen ESC-based translational science in Europe. Industry has to have IP protection or there is no way they can risk, in an already risky field, to proceed with such research.
Ambiguity is like a kiss of death for for-profit biotech companies. While many of us are hopeful that academic institutions will get more directly involved in the business of early clinical trials and stem cell drug development, clearly we need industry involvement to overall advance the field and help patients.
Some might view this ruling as a victory for companies in the U.S. doing ESC-based research since patent protection of ESC technology is rock solid, but I don’t view it that way. Stem cell research is very much an international endeavor and what is bad for Europe is not necessarily good for the U.S. Witness that ACT has trials in the U.S. and Europe. In addition, while some may say that ACT itself may not be affected by this ruling due to its blasomere-based ESC lines, any ambiguity is bad. Whether some firms survive or not may depend on stem cell patent decisions both in the US and EU as well as elsewhere.