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EU court ruling could make it easier to get patents for cell therapies, says expert

A ruling by the EU's highest court should make it easier for biotech companies to obtain patents for inventions from human embryonic stem cell research, an expert has said.

However, Helen Cline, a specialist in patents and life sciences at Pinsent Masons, the law firm behind Out-Law.com, said that the judgment leaves it in the hands of national courts across the EU to assess the patentability of inventions in this field. 

The Court of Justice of the EU (CJEU) was considering a case referred to it from the High Court in London where the International Stem Cell Corporation (ISCC) challenged decisions by the UK's Intellectual Property Office (IPO) to refuse two patent applications it made. The patent applications concerned inventions ISCC had claimed in stem cell research it had conducted. 

The patentability of inventions deriving from human embryonic stem cell research has been a controversial issue. In the EU, the Biotech Directive states that "uses of human embryos for industrial or commercial purposes" shall be considered unpatentable. 

However, in its High Court appeal, ISCC had claimed that a 2011 CJEU ruling meant that its applications concerned tissues which are not excluded from patentability. 

In this earlier case the CJEU had ruled on the meaning of the term 'human embryo' and said that any organism that is "capable of commencing the process of development of a human being" should be considered a human embryo, and gave examples where both fertilised and non-fertilised human ovums would be said to constitute human embryos. 

The CJEU, however, also left it to national courts to decide "in light of scientific developments" whether a stem cell obtained at the blastocyst stage, which is a very early stage of development, constitutes a human embryo within the meaning of the Biotech Directive. 

In its judgment issued on Thursday, the CJEU has further clarified the position. 

"An unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine," the CJEU said in its ruling. 

Cline said the CJEU had followed the earlier non-binding opinion issued in the case by an advocate general of the court in July, and that the decision would be welcomed by the biotech industry. 

"For biotech companies who develop cellular therapies this will be welcome news," Cline said. "On its face the decision could increase the possibility of securing patent protection for such therapies across the EU and could remove some of the existing uncertainty for investors." 

Cline said that opinion is divided about the patentability of biotech inventions and that it had taken more than 10 years to agree on the final wording of the EU Biotech Directive to both "encourage biotechnology innovation and address the varying ethical concerns" within EU countries. 

"The field of human embryonic stem cell research and related cloning technologies continues to be a contentious issue world-wide," Cline said. "In Europe, the member states of the EU are each wrangling with the issues raised by embryonic stem cell research and coming to very different conclusions. The on-going debates are driven mainly by the diversity of opinion on the ethical cost-benefit analysis of human embryo and human embyronic stem cell research. It is widely acknowledged that such research may yield immense benefits for mankind and revolutionise medicine. However, many believe that these great benefits might not warrant what has been termed ‘the instrumentalisation of persons’." 

"The broad interpretation of the term ‘human embryo’ adopted by the CJEU in the 2011 case has been limited and now excludes parthenotes that have not got the inherent capability of developing into a human being. However, opinion was divided amongst the member states that submitted observations to the CJEU, most agreeing with the patentee that parthenotes should not be considered ‘human embryos’ but it was argued that there was a risk that parthenotes could perhaps acquire the ability to become human beings by additional manipulation. It will now be for national patent offices and courts to consider this risk on a case by case basis, in the light of current scientific knowledge," Cline said. 

Adrian Murray, patent law and life sciences expert at Pinsent Masons, said it would be interesting to see how the CJEU's findings relate to new unitary patents in the biotech sphere once they come into existence. 

Murray said that it was all very well to allow individual EU countries to set the public policy and moral threshold for assessing whether inventions from human embryonic stem cell research are patentable or not, but said it is unclear how the unified patent courts (UPCs) would consider the issue in relation to unitary patents. 

"While the ability for the threshold of ‘morality and ordre public’ to be assessed on a country by country basis is fine for national patent rights, or European patents validated nationally, under current regimes, it is interesting to see how this determination will be made for unitary patents under the forthcoming UPC system, where patents cannot be found to be invalid on a national basis, but must stand or fall singly, across all of the participating EU member states," Murray said.

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