OT: Stem cell research thrives, despite EU patent ruling on destruction of embryos
Scientists working with stem cells have found ways to ensure their treatments can be patented and are commercially viable
A ruling by the Court of Justice for the European Union at the end of last year that procedures using embryonic stem cells cannot be patented sent a shockwave through the biotechnology industry. However, one year on, human stem cell research is still thriving as it innovates to side-step the ethical issues surrounding the destruction of embryos.
In fact, long before Greenpeace brought its case against the German neuroscientist, Oliver Brüstle, to the court last year, research scientists had been exploring ways to create human stem cells using alternative methods.
The court's controversial decision, which determined that any invention is unpatentable if it necessitates the destruction of a human embryo, regardless of when that took place, has served to accelerate the search for these new methods. When the decision came, research scientists realised that all work involving embryonic human stem cells had been rendered commercially worthless and was therefore at risk.
The European Patent Office (EPO) had been granting patents relating to embryonic stem cells for cases filed after the cell lines were made available to the public in 2003. Their position is based on the view that, as the cells were obtained from an established line, performing the patented invention did not necessitate the destruction of a human embryo.
However, there is now concern that this view may not be in accordance with the court's decision, as these cell lines did originally require the destruction of a human embryo.
Scientists are now able to create human stem cells by "reprogramming" a mature human cell taken from a living donor to become a versatile cell known as an induced pluripotent stem cell (iPS). It is thought that this breakthrough could eliminate the need for stem cells sourced directly from human embryos. And, crucially, inventions developed using human stem cells sourced using this new method are still very much patentable.
In recognition of their important work in this field, Japan's Shinya Yamanaka and Britain's James Gurdon won the 2012 Nobel Prize for Medicine last month.
As the first human trials get under way, stem cell research projects are reaching a critical stage. Earlier this year, the first trial results from a research project involving embryonic human stem cells were published, showing how two women in the US received breakthrough treatment for an eye condition which resulted in an improvement in their vision. More recently, other studies have produced promising results, demonstrating how adult stem cells can be rejuvenated to help regrow healthy heart tissue in patients who have had a heart attack.
If such potentially life-saving medical research is to continue, the patentability of these inventions must be secured. If companies investing large sums of money in developing stem cell-based therapies are not able to protect their innovations, then they will stop doing so in future.
Speaking at a conference in Paris, Shinya Yamanaka warned this week that the matter of ethics will remain a barrier to stem cell research for some time yet. He explained that new ethical issues are emerging regarding the potential production of germ cells – sperm or eggs – from differentiated cells.
While some uncertainty remains about the future of stem cell research, researchers have demonstrated their ability to address ethical concerns and in doing so have ensured that their work remains patentable and commercially viable. As long as those involved in stem cell research can patent therapies that people need and health organisations want to buy, this field will continue to thrive.
All wonderful cures-but they are going to fight and make ridiculous claims of weak ethics-both sides sounded dumb. SCientists worked very hard to be ethical over the years-to come to the point where you don't need embryos. The sperm/egg question needs heavy duty guidelines.