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18 December 2014Europe

CJEU lays down stem cell patent rules

Europe’s highest court has said that an organism incapable of developing into a human does not constitute a human embryo and therefore uses of it can be patented.

The Court of Justice of the European Union (CJEU) was ruling on a case brought by a US organisation asking whether it could patent processes covering the use of human cells.

The CJEU’s decision, issued today (December 18), upholds a ruling from Advocate General (AG) Cruz Villalón from July. The CJEU is thought to follow the AG’s opinion in 80% of cases.

“An organism which is incapable of developing into a human being does not constitute a human embryo within the meaning of the Biotech Directive. Accordingly, uses of such an organism for industrial or commercial purposes may, as a rule, be patented,” the court wrote this morning.

The CJEU was considering the question following a referral from the English High Court.

It had to decide whether certain types of cells, called parthenotes, fall within the definition of “human embryos” under the Biotech Directive, which outlines the legal protection of biotechnological inventions in the EU.

The case was brought by International Stem Cell Corporation (ISCC), which had been in dispute with the UK Intellectual Property Office and its comptroller general of patents, designs and trademarks after they refused to grant it two patents.

Assessing the case, Dominic Adair, partner at law firm Bristows, said research in the biotech sector was “moving at an incredibly fast pace” and that the race to find revolutionary solutions to illness is particularly on between Europe and the US

“There have been dramatic developments in the field of stem cell research, which means cells can be manipulated to have characteristics of embryos without necessarily conforming to the typical definition of an embryo,” Adair said.

The CJEU said UK judges will be left to determine whether the specific organisms used by ISCC lack the capacity to develop into human beings and therefore uses of them meet the patentable criteria.

Jason Rutt, executive at law firm Rouse, said the court seemed to take a “very sensible position”.

He added: “The judgment refers to a common core; a nucleus of things is excluded under the directive. There remains the possibility that national courts have discretion to still rule it’s not patentable. However, there is no absolute bar to patentability.

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