Tuesday, October 18, 2011

Experts View European Court Ruling as a Setback for Stem Cell Therapies

Geoff Lomax is CIRM's Senior Officer to the Standards Working Group

The European Court of Justice issued a ruling today that therapeutic products created from human embryonic stem cells are not patentable. A press release cites the court's decision:
Court holds that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in the present case, does not refer to the use of human embryos.
James Lawford-Davies presented background on the case at the World Stem Cell Summit October 5 in Pasadena. He says the decision is seen as "a victory by those opposed to the use of embryos for research in the EU". Aurora Plomer, a legal scholar at the University of Sheffield, concurs:
"The ruling of the Court of Justice of the European Union could be in breach of the European Convention on Human Rights in failing to recognize the margin of discretion granted to Member States on the rights of human embryos."
Researchers are equally disappointed. An AP story quotes Pete Coffey, who received a CIRM Research Leadership Award to support his move from University College London to the University of California Santa Barbara. Coffey has been developing an embryonic stem cell-based approach to treating the most common form on blindness.
"This is a devastating decision which will stop stem cell therapies' use in medicine," Pete Coffey, a stem cell researcher at University College London, said in a statement. "The potential to treat disabling and life-threatening diseases using stem cells will not be realized in Europe."
The Guardian quotes Austin Smith, head of the Wellcome Trust Centre for Stem Cell Research at Cambridge University, who said that the decision left European scientists is a "ridiculous position".
"We are funded to do research for the public good, yet prevented from taking our discoveries to the market place where they could be developed into new medicines. One consequence is that the benefits of our research will be reaped in America and Asia."
Lawford-Davies says he still holds out hope for the field for the following reasons:
  • Inventors and patent attorneys have known about this concern for some time and have been drafting to try to take account of the court position.
  • It should be possible to obtain patents on allied technologies, such as biomarkers and diagnostics related to the particular therapy. 
  • It is still possible to obtain these types of patents in most other countries in the world, including the US.


  1. Advanced Cell Technology has a technique that can be licensed to others that does not destroy the embryo. What I'm saying is that it does not end all research activities. They've found a way around it and others can too. I find it amazing that there is no mention of their process by CIRM. It sure looks like CIRM backed the wrong horse this time and they refuse to even mention the good things that ACTC has going for it. I guess the bias will continue to show up in ways unexpected.

  2. ACT's blastomere technology, where they only use one cell of the early embryo, is unique and very cool, but as I blog about here (http://www.ipscell.com ) this ruling is not good news for ACT either. Any kind of ambiguity about IP rights is very bad and one illogical decision can lead to others such as someone saying that ACT's technique actually does harm the embryo. I'm not saying this makes sense (quite the opposite) but the situation is unsettled and investors don't like that. Word arounds are slow and even riskier than the average, already very risky biotech situation.
    BTW, I don't see any bias by CIRM towards ACT.

  3. Make believe it was you that was waiting...

    Timing for Clinical Trials for Stem Cell Therapy in Spinal Cord Injuries Is Right, Review Suggests

    Stem cell research brings tremendous hope to those who remain paralyzed after such a devastating injury. But according to Dr. Fehlings, patients are not able to realize the potential benefits of stem cell therapy because research is largely stuck in the laboratory.

    “With the exception of a few clinical trials, current research is stalled at the animal model stage,” said Dr. Fehlings. “Scientists from around the world have demonstrated as much as they can in lab models that stem cells have an impact on spinal cord injuries and can be transplanted into patients. Now we need the support and coordination of regulatory bodies to move this science forward.


  4. Even use of a single cell from a human blastomere could be construed as "prior use as base material" of an embryo. As such, ACT's technology would be blocked as well.

  5. It doesn't seem like this ruling would affect therapeutic products from induced pluripotent stem cells (iPSCs). Does anyone know?