Human Eggs That Can’t Develop Into Human Beings Should Be Patentable, EU High Court Advisor Says

Unfertilised human eggs that can’t develop into human beings are generally not “human embryos” within the meaning of the EU directive on the legal protection of biotechnological inventions, a 17 July European Court of Justice Advocate General opinion said. The opinion is good news for researchers into stem cell therapies, said a member of the industry group IP Federation, who added he hopes it will be upheld by the ECJ. But one biotech civil society member said the ruling, if it stands, could be abused.

The case, International Stem Cell Corporation (ISC) v. Comptroller General of Patents, was referred to the ECJ by the UK High Court of Justice. The matter offers the ECJ an opportunity to reconsider the meaning of “human embryos” in Article 6(2)(c) of the directive, said Advocate General (AG) Pedro Cruz Villalón’s opinion.

The EU high court addressed a similar question in 2011 in Oliver Brüstle v. Greenpeace (IPW, European Policy, 18 October 2011), Villalón noted. There, the issue was whether unfertilised human ova whose division and further development have been stimulated by parthenogenesis (known as “parthenotes”) are human embryos under the directive. The ECJ said yes, and outlawed the patenting of such stem cells for scientific research or commercial purposes.

In ISC, the question was whether unfertilised human eggs, whose division and further development have been stimulated by parthenogenesis and which, in contrast to fertilised eggs, contain only pluripotent cells and are incapable of developing into human beings, are human embryos under the directive.

The AG opinion said such ova aren’t human embryos but added a caveat: If the unfertilised egg is genetically manipulated in such a way that it can develop to term and become a human being, it would be covered by the directive.

The case is an important one because it’s expected to offer further guidance on the embryo definition to be applied under European law, said a European Patent Office spokesman.

Good News for Patients

The AG opinion supports the IP Federation’s stance that parthenotes shouldn’t be considered human embryos, said the Federation member. Parthenotes can’t become human beings because they don’t contain any paternal DNA, a fact that the earlier ECJ decision in Brüstle appears to have been unclear about, he said. If the high court follows the opinion, more stem cell technology will be patentable, making more stem cell therapies likely, he said.

If, however, the ECJ opts to disregard the AG opinion, the broad definition of human embryo set by Brüstle may stand, and many potential stem cell inventions might not be patentable, the IP Federation member said.

Putting Pressure on Egg Donors?

The proposed ECJ decision could “give a commercial incentive for asking donors for oocytes,” said Christoph Then, executive director of Testbiotech, which identifies itself as a non-profit organisation that promotes independent research and public debate on the impacts of biotechnology. He cited an academic article that claims patent applications were a reason for asking women to contribute their eggs for research, which raises “substantial ethical concerns.” While the article might not be directly applicable to ISC, it shows the issue must be considered, he said. Then said he was speaking personally.

In addition, the exclusion from the directive proposed by the AG, “might be used as a legal loophole that could be abused by patent applicants to escape Article 6just by a clever wording of the claims,” Then said. “Doubts remain” about the AG opinion, he added.