Newer methods that can generate hESCs without destroying embryos could render the court’s decision moot.

This week the highest court in Europe ruled that stem cell research based on the destruction of human embryos is contrary to morality and cannot be patented. The Court of Justice of the European Union sided with arguments by its advocate general, who earlier this year termed stem cell patents “contrary to ethics and public policy.”

Oliver Brüstle, Ph.D., since 2004 has fought to maintain a 1997 patent covering methods for deriving neural cells from hESCs despite a challenge from Greenpeace. Dr. Brüstle is director of the Institute of Reconstructive Neurobiology at the University of Bonn. After a German court ruled in favor of Greenpeace, Dr. Brüstle appealed, and the case was referred to the Court of Justice.

“An invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos,” the court elaborated in its judgement.

The European Patent Office (EPO) stopped granting hESC patents in 2006, though, national patent offices across the continent continued to do so. The EPO police was an outgrowth of the EU’s 1998 directive “98/44/EC” on the legal protection of biotechnological inventions, which banned the patenting of inventions “where the technical teaching that is the subject matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”

The court also cited the Convention on the Grant of European Patents, signed in 1973, which declared that European patents shall not be granted in respect to “inventions the commercial exploitation of which would be contrary to ordre public or morality.”

Bernard Siegel, founder and full-time executive director of the nonprofit Genetics Policy Institute, states, “In the short term it will have impact on developing products using human embryonic stem cell research as its base. That’s unfortunate.
“But I don’t think on a global scale, it’s going to stop this field from moving forward. The tide of history surely remains on the side of embryonic stem cell research and its translation to cures. A single setback like this isn’t going to impede the field for very long,” Siegel added. “There has to be an alignment of interest between the patient advocacy community and the companies that are going to translate this lab work into treatments and cures.”

In a statement, Greenpeace welcomed the court decision. “By blocking the patenting and commercialization of human embryos, the European Court of Justice has today strengthened the protection of human life against commercial interests within the EU,” said senior campaigner Lasse Bruun. “We hope that national patent offices follow the ECJ decision by not granting patents on human embryonic cells.”

The head of a U.S. stem cell company predicted the decision’s impact could be more limited than Greenpeace and its supporters anticipate. “The Court appears to have clearly focused its decision on those processes relying on now dated traditional and destructive methods for generating embryonic stem cells from the inner cell mass of embryos yet seems to provide for a continuing basis for patentability of process of generating human embryonic stem cells and products derived from those cells where nondestructive techniques can be used,” Gary Rabin, chairman and CEO of Advanced Cell Technology (ACT), explained.

Writing in his blog, Rabin added, “This ruling is most unfortunate and represents a huge setback to hESC-based research and development in Europe. However, it should have minimal impact on our commercial efforts in the EU.”

The reason, he said, is because ACT’s European programs employ its single-cell blastomere technique, which allows for deriving hESC lines without destroying embryos. Last December, ACT announced a collaboration with Roslin Cells of Scotland using that technology to establish a bank of GMP-grade human embryonic stem cell lines and make the lines available for both research and commercial purposes.

As to whether the European court decision could benefit Asian or U.S. stem cell companies, Siegel said it is too soon to say. “Whatever is gained in a competitive advantage, it doesn’t help a company considering that same patent right might not be applied for in Europe,” Siegel pointed out. “A lot of the basic research related to embryonic stem cells is still going to take place. How much of that is in Europe or if there is an incentive to proceed because of eventual commercialization in Europe is an unknown at this point.”

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