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European court’s ban on stem cell patents will harm research, say scientists

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d6787 (Published 18 October 2011) Cite this as: BMJ 2011;343:d6787
  1. Clare Dyer
  1. 1BMJ

Research methods that involve the removal of stem cells from a human embryo that is destroyed cannot be patented under European law, the European Court of Justice has ruled.

In a judgment with profound implications for the development of stem cell therapies, the court held that a process involving the removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.

Scientists said that the ruling may fetter the development in Europe of stem cell treatments for a range of diseases from Parkinson’s to blindness, because drug companies would not want to make the large investment needed if they could not protect their discoveries by patent.

Austin Smith, from Cambridge University’s Wellcome Trust Centre for Stem Cell Research, said, “This unfortunate decision by the court leaves scientists in a ridiculous position. We are funded to do research for the public good yet prevented from taking our discoveries to the marketplace, where they could be developed into new medicines. One consequence is that the benefits of our research will be reaped in America and Asia.”

Pete Coffey, of the Institute of Ophthalmology at University College London, said, “This is a devastating decision that will stop stem cell therapies’ use in medicine. The potential to treat disabling and life threatening disease commonly using stem cells will not be realised in Europe.”

The case reached the European Court of Justice in Luxembourg after Greenpeace challenged a patent held by Oliver Brüstle, director of the Institute for Reconstructive Biology at Bonn University. The patent relates to neural precursor cells produced from embryonic stem cells used to treat neurological diseases. Professor Brüstle told the court that there were already clinical applications, particularly for Parkinson’s disease.

The German federal patent court ruled that the patent was invalid, and Professor Brüstle appealed to the Federal Court of Justice. That court asked the European Court of Justice to decide whether a ban on patents for the use of human embryos for “industrial or commercial purposes” in the 1998 European Union directive on the legal protection of biotechnological developments covered scientific research.

The European Court of Justice ruled that it did, although a patent could be granted where an embryo was used for therapeutic or diagnostic purposes useful to the embryo, such as to correct a malformation and improve the chances of life.

The case now goes back to the German courts for a final decision

Sarah Turner, a patent lawyer at the law firm Hogan Lovells, said, “Unless effective, alternative sources of cells can be found for stem cell research, this ruling will have an enormous effect on the fledgling stem cell industry. If patent protection cannot be obtained, investment in this area is likely to decrease. Investors look to the rights granted by patents as a means to recover the huge costs of research in this area and support ongoing and future research. Without proper protection the incentives to innovate are eroded.”

Professor Brüstle said, “With this unfortunate decision, the fruits of years of translational research by European scientists will be wiped away and left to the non-European countries. European researchers may conduct basic research, which is then implemented elsewhere in medical procedures, which will eventually be re-imported to Europe. How do I explain this to my students?”

Notes

Cite this as: BMJ 2011;343:d6787

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