The Battle to Patent Human Stem Cells

An upcoming European Court ruling could allow an American company to patent stem cells.

Jul 18 2014, 1:55pm
Image: Shutterstock/koya979

An upcoming European Court of Justice decision could change the landscape of stem cell research after a top adviser published an opinion suggesting that researchers should be able to patent human stem cells.

Until now, this wasn’t possible because the stem cells in question are derived from human eggs and the EU Biotech Directive excludes human embryos from being patented. But the definition of exactly what counts as an embryo is a tricky question under that law. As you can probably imagine, it’s a divisive debate. 

The case currently in question, as The Wall Street Journal reports, is brought by US-based company International Stem Cell Corporation, and concerns stem cells derived from human eggs. The thing is, these stem cells could never develop into a human being. They are parthenotes—unfertilised eggs that are induced to develop by a chemical process. While the stem cells are able to form human tissues, they’re not able to form human beings as they don’t contain any genetic material from the father.

ISCC’s patent applications were rejected by the UK, which led them to appeal to the European Court of Justice. In his opinion on the matter, Advocate General Pedro Cruz Villalón agreed that parthenotes therefore shouldn’t come under the definition of an embryo. An EU release explained that “the mere fact that an unfertilised ovum is capable of engaging in a process of cell division and differentiation similar to that of a fertilised ovum does not suffice in itself to consider it as a human embryo.”

That’s a bit of a curveball for European law, which effectively banned embryonic stem cell patents in a previous case. German researcher Oliver Brüstle fought to be able to patent a technique based on embryonic stem cells but the court ruled against it. In his case, he used pluripotent cells—which also can’t develop into humans—but the real sticking point for the Court was that the cells were taken from an embryo that was destroyed in the process.

That put European researchers in the awkward position of being able to work with embryonic stem cells but unable to patent their discoveries. A group of leading stem cell researchers expressed their dismay at the effective ban on patents in a letter in Nature, and Brüstle argued that it left them unable to fully benefit from their own work.

“With this unfortunate decision, the fruits of years of translational research by European scientists will be wiped away and left to the non-European countries,” he argued at the time. “European researchers may conduct basic research, which is then implemented elsewhere in medical procedures, which will eventually be re-imported to Europe.”

That’s important, because getting ahead in the field could bring massive advantages. Stem cell research has been responsible for some groundbreaking discoveries recently, and the stakes are high; Brüstle, for instance, was working on developing therapies for Parkinson’s disease.

The European Court of Justice is expected to follow Cruz Villalón’s opinion in this case, which would mean ISCC could get a patent for the technology it uses to produce stem cells (it’ll be up to individual European countries to decide if they want to allow it). 

Aurora Plomer, a professor of law and bioethics at Sheffield University who wrote against the Brüstle ruling, told me the new opinion was a step in the right direction, but noted that if the EU Court followed the opinion, a US company could be getting a patent for an invention circumventing the Brüstle ruling, while related work on human embryonic stem cells by European researchers remains unpatentable. The ISCC case wouldn’t change the main gist of the Brüstle ruling—the company has effectively found a way around it, instead. “It still comes on the back of  a ruling which has severely limited the opportunities for European research to avail itself of patent protection,” she said.

And even with a new precedent, the issue is unlikely to be settled once and for all. In his opinion, Cruz Villálon noted that the situation may change in the future if we find that parthenotes can, in fact, be genetically altered so as to develop into human beings. That kind of genetic manipulation has already been demonstrated in mice, and while it’d likely be illegal in humans, it could one day be possible. 

As progress continues to be made in the often controversial field of genetics, our ideas of what it is to be human, or at least a could-be human, will continue to change.