‘Legal bombshell’ threatens European stem cell treatment

PATIENTS could be denied revolutionary stem cell treatments by a legal bombshell from Europe that threatens to blow apart the biotech industry, scientists have warned.

The European Court of Justice is considering a test case that could make it unlawful to patent applications using embryonic stem cells on moral grounds.

Fears about the outcome have been raised by an influential ruling recommendation that patenting the use of human embryo cells breaches ethical principles.

That advice was given by Yves Bot, one of eight “advocate generals” appointed to provide reasoned, independent guidance to the court. They have a powerful voice, and while their opinions are not binding, they are frequently followed.

A European legal ban on embryonic stem cell patents will have potentially catastrophic consequences for the multi-billion euro European biotech industry and patients, the scientists say.

13 leading researchers in the field spelled out their concerns in a letter.

They include clone pioneer and “Dolly the Sheep” creator Professor Ian Wilmut, chairman of the Scottish Centre for Regenerative Medicine in Edinburgh, and Professor Austin Smith, director of the Wellcome Trust Centre for Stem Cell Research in Cambridge.

Speaking at a press conference in London, Prof Smith said the advocate general’s opinion, issued in a public statement, was “astonishing and shocking”: “If the European Court of Justice was to follow this opinion then the reality... is that all patents in Europe that involve human embryonic stem cells will be eliminated.

“Other patents will apply in the United States, China and Japan, so this will put Europe at a huge disadvantage. It will effectively wipe out the European biotech industry in this area.”

Licensing authorities would effectively be prevented from approving therapies based on the “immoral” commercialisation of embryonic stem cells.

More than 100 patents on embryonic stem cell products have already been filed in Europe. But advanced stem cell treatments are only just starting to make the transition from lab to clinic.

The first British trial, led by Professor Pete Coffey from University College London, will use cells derived from embryonic stem cells to treat an incurable form of age-related macular degeneration, an eye disease.

Two other clinical trials involving a stem cell treatment for spinal injuries and another degenerative eye disease are already under way in the US.

Prof Coffey, one of the letter’s signatories, said: “There’s an ethical need to treat disease which appears to have been lost in this whole debate.”

He said obtaining permission for a clinical trial partly depended on the likelihood of ending up with a licensable product.

While “new” embryonic stem cells are extracted from early stage human embryos — usually surplus embryos from IVF treatment — few if any are now used in research. Instead scientists rely on proliferating cell cultures that have been maintained in laboratories for years.

Such cells can be chemically coaxed into forming different kinds of body tissue for use in treatments. They may be also be used as screening tools to test the toxicity of drugs, as an alternative to animal models.

But because they originally started out as cells taken from cannibalised embryos, they would still be affected by the European Court patent ruling. Theoretically so would any technology that can be traced back to a fertilised human egg.

The case before the European Court of Justice began as a legal battle over a patent granted in 1999 to Professor Oliver Bruestle, from the University of Bonn in Germany. He wanted to safeguard his method of producing nerve cell precursors from embryonic stem cells.

Prof Bruestle’s patent was challenged in the German courts by the environmental group Greenpeace in 2004. Two years later the dispute was referred to the European Court of Justice by the German Federal Patent Court.

Prof Smith said patenting was a “key vehicle” for the successful transfer of stem cell research into applications that can help patients.

The legal ruling will be made by the European Court of Justice’s “grand chamber” of 13 judges. Typically the process takes several weeks. Once a ruling is made it will be binding on all member states.