Stem Cell Ethics: European Court Rejects Embryonic Stem Cell Patents

With its potential to regenerate damaged and diseased organs, stem cell research can revolutionize the future of medicine.

Human embryonic stem cells (hESCs), in particular, have the ability to turn into any of the 200 or so cell types in the body. This means that hESCs may potentially be used to develop medical therapies to treat previously untreatable diseases. These may even be used to regenerate damaged organs that used to be replaced with donated organs. Where hESCs are concerned, the possibilities are endless.

This is why the controversy over human embryonic stem cells is one that affects us all—and one that should therefore concern us all.

But a landmark ruling made by Europe’s top court late last year escaped public notice.

In a judgment with widespread consequences, European Court of Justice in Luxembourg on Oct. 18, 2011 ruled against patenting any process that involves removing a stem cell from, then destroying, a human embryo.

Inventions based on the use of hESCs for scientific research purposes can’t be patented, the court ruled, saying that European law forbids this.

“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,” the ruling read.

At the blastocyst stage — which occurs about five days after fertilization just before implantation into the womb—the embryo consists of around 80 to 100 cells. At this stage, stem cells are what scientists like to call “eternal” or “immortal” because they can continue to grow indefinitely under the right conditions. This means that they can be used continuously for research and scientists don’t have to acquire a production line of embryos.

In its ruling, the court said “scientific research entailing the use of human embryos cannot access the protection of patent law.” But patents are permitted where the technique was useful to the human embryo itself “to correct a malformation and improve the chances of life.”

The ECJ said its ruling reflects European law, which protects human embryos. A European directive on biotechnology patents “intended to exclude any possibility of patentability where respect for human dignity could thereby be affected,” it said.

Test case
The test case involved a patent filed in 1997 by Dr. Oliver Bruestle, a German neurology professor and one of the world’s leading stem cell research pioneers.

Prof. Bruestle filed a patent over the creation of nerve cells from hESCs, saying there were many potential clinical applications, especially treatments for deadly neurological diseases like Parkinson’ s.

Greenpeace e.V. challenged the German patent awarded to Dr. Bruestle, saying it was suing for “ethical reasons.” The environmental group said it chose to oppose Dr. Bruestle’s patent because it was seeking a fundamental decision on how the protection of human embryos is to be laid out under EU patent law.

Greenpeace wanted the patent to be declared invalid for moral reasons (“ordre public”), in light of ethical objections to the commercialization of the fundamentals of human life.

Under an EU law from 1998, research methods that involve human embryos for industrial or commercial purposes can’t be patented.

Last year, the Federal Court of Justice, Germany’s highest civil court, sought the EU tribunal’s guidance on the case. It asked the ECJ for its view on how to interpret this law and the term “human embryo.”

“We wanted a fundamental decision about the protection of embryos under European patent law and we got that clarity today,” Christoph Then, a Greenpeace official in Luxembourg told reporters on the day the European court made the ruling. “The court has said that ethics take priority over commercial interests.”