European judgment opens way for stem-cell patents

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December 18, 2014
Andrew Ward in London

Lawyers described the judgment as a boost for medical research in Europe, three years after the EU court had ruled that work involving human embryos could not be patented.

“It walks a clear line to exclude the sci-fi horrors of the abuse of human embryos whilst allowing the use of techniques to generate stem cells which may alleviate much human misery,” said Jason Rutt, a patent attorney at Rouse, the law firm.

The case had been closely watched as a test of whether the intellectual property rules that underpin private sector investment in medical research could be fully applied to a new generation of products developed using human stem cells.

Stem cells are the precursors of all cells in the body, and have been identified by scientists as the potential key to treatments capable of repairing defective cells to cure a range of diseases. But stem-cell research has proved highly controversial because of ethical concerns over the use of human embryos.

Thursday’s ruling was prompted by the US-based International Stem Cell Corporation’s attempt to patent a process to extract stem cells from unfertilised human eggs.

The application was rejected by Britain’s patent office on the basis of the EU ban on patenting human embryos. But UK judges referred the case back to the Luxembourg-based court for clarification on how the law should be applied.

In its latest ruling on Thursday, the EU court reaffirmed that a non-fertilised human egg could not be patented if it had “the inherent capacity of developing into a human being”. But it added that not all egg cells met this criteria.

“The mere fact that a parthenogenetically activated human ovum commences a process of development is not sufficient for it to be regarded as a ‘human embryo’,” said the court.

Dom Adair, a partner at the law firm Bristows, said: “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.

“This decision will serve to maintain the momentum in biotech research and gives great hope for the development of advanced therapies for diseases.”

Stem-cell research has been slow to produce the medical breakthroughs that its advocates have predicted. But there have been signs of growing momentum, with 104 stem-cell therapies in late-stage clinical development, according to GlobalData, the research company.

“The scientific advancement of adult stem cells and the new technology’s demonstrable clinical benefits have led to increasing patient acceptance,” said Aparna Krishnan, a healthcare analyst at GlobalData, predicting that stem cells were set “to become an integral part of the pharmaceutical industry’s R&D process”.
 
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