The European Union’s highest court said that stem-cell research involving human embryos can’t be patented, in a ruling that scientists called “devastating” for medical research.
Inventions based on the use of human embryonic stem cells for scientific research purposes can’t be patented, the European Court of Justice in Luxembourg said. The case was triggered when Greenpeace challenged a German patent awarded to Oliver Bruestle, a professor and specialist in stem-cell research.
“This is an unbelievable setback for bio-medical research in the area of stem cells,” Bruestle said in an interview after the ruling. The EU court “took an extreme position on restrictions in this area, which will have huge repercussions globally, especially in the competition with the U.S. and Asia, and in scientific research.”
Under an EU law from 1998, research methods that involve human embryos for industrial or commercial purposes can’t be patented. A German court handling the dispute at the center of today’s case sought the EU tribunal’s view on how to interpret the phrase “for scientific research involving human embryos” and to clarify the term “human embryo.”
“A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented,” said the EU court. The blastocyst stage is about five days after fertilization.
Greenpeace, which said it sued for “ethical reasons,” argued the patent for a stem-cell research process developed by Bruestle to treat neural diseases is invalid because it covers cells derived from human embryos. The Federal Court of Justice, Germany’s highest civil court, last year asked the EU tribunal for guidance on the case.
“We wanted a fundamental decision about the protection of embryos under European patent law and we got that clarity today,” said Christoph Then, a spokesman for Greenpeace. “Commercial interests have to take a backseat and integrity has to take over.”
The court clarified that “only use” of human embryos “for therapeutic and diagnostic purposes which are applied to the human embryo and are useful to it” are patentable.
Researchers called today’s decision “unfortunate.”
“One consequence is that the benefits of our research will be reaped in America and Asia,” said Austin Smith, a professor at the Wellcome Trust Centre for Stem Cell Research at the University of Cambridge.
“This is a devastating decision which will stop stem cell therapies use in medicine,” said Pete Coffey, a professor at the Institute of Ophthalmology at University College London.
The initial research carried out in Europe with European funds “will be more likely to be developed and used in other parts of the world,” said Ian Wilmut, a professor at the MRC Centre for Regenerative Medicine at the University of Edinburgh.
The ruling might actually allow scientists a “sigh of relief,” said Julian Hitchcock, a lawyer and intellectual property specialist in the London office of law firm Field Fisher Waterhouse LLP.
Researchers “won’t have to worry about inadvertently infringing someone else’s patent,” said Hitchcock in a phone interview. “While the ruling restricts patentability of such inventions, it doesn’t in any way restrict the use of embryonic stem cells.”
While patent protection might not be available, European scientists can seek so-called data exclusivity, which protects documentation for as much as eight years and prevents the marketing of competing products based on the same data for up to 10 years, said Hitchcock.
The case is: C-34/10, Prof. Dr. Oliver Bruestle v. Greenpeace e.V.