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Selasa, 15 Maret 2011

European Court of Justice rejects stem-cell patents


The European Court of Justice today issued a preliminary opinion that procedures involving established human embryonic stem (hES) cell lines are not patentable.

The opinion has wrong-footed stem-cell researchers, who had been expecting a less conservative judgement.

"It's the worst possible outcome," says Oliver Brüstle, director of the Institute of Reconstructive Neurobiology at the University of Bonn in Germany, whose 1991 patent of a technique to generate nerve cells from established hES cell lines sparked the legal debate. Brüstle hopes that his patented work will eventually lead to the generation of nerve cells that could be used to repair damage to the brain or spinal cord.

The preliminary opinion was prepared by Judge Yves Bot, the court's advocate general. The case was presented in November 2009 by the German Federal Supreme Court, which had requested clarification of the legal definitions of human embryos in relation to patentability after it had trouble adjudicating a challenge to Brüstle's patent from the environmental organization Greenpeace, based in Amsterdam. Greenpeace said that the patent was unethical because hES cell lines are derived from human embryos.

European Union guidelines on biotechnology patenting are hazy when it comes to techniques involving cells derived from human embryos. That ambiguity applies to the embryos that provide starting materials for cultured hES cell lines — such as spare embryos from in vitro fertilization procedures — which would have been destined for destruction anyway.

The preliminary opinion will now be considered by the 13 judges in the court's Grand Chamber, whose final decision is expected within a couple of months. If the Grand Chamber agrees with Bot's opinion — and few preliminary opinions are reversed, says a spokesperson for the European Court of Justice — it could spell difficulties beyond the issue of patenting for researchers in other European countries.

National rules

Legislation covering hES cell research varies across Europe. Some countries, such as the United Kingdom and Sweden, are relatively liberal and allow research on fresh hES cells that are still totipotent, meaning that they would still have the potential to develop into a human if they were transplanted into a womb. Others are more restrictive: Germany, for example, allows research only on imported hES cell lines created before May 2007. Such cell lines comprise pluripotent cells capable of developing only into defined organs. And some countries, including Ireland, have yet to legislate. They are "quite obviously going to refer to a legal opinion at the European level for guidance", says Hans Schöler, a stem-cell researcher and director of the Max Planck Institute for Molecular Biomedicine in Münster, Germany.

In his judgement, Bot concludes that pluripotent stem cells cannot be defined as embryos because "they are no longer capable of developing into a complete human being". However, he adds that the embryonic source of pluripotent cells "cannot be ignored". Bot argues that techniques involving hES cell lines are not patentable — even if the process in question does not involve the direct destruction of embryos — because they are tantamount to making industrial use of human embryos, which "would be contrary to ethics and public policy".

Scientists fear that a legal opinion that the embryonic origin of hES cell lines cannot be neglected — however long ago the hES cell lines were established — is likely to encourage vacillating countries to introduce restrictive laws or complete bans. Patent expert Clara Sattler de Sousa e Brito, who is a member of Brustle's legal team, says that in all patent jurisdictions the scope of a patent is defined by what that patent claims, not by issues that are outside of the claim, as the original source of hES cell lines would be.

The final opinion of the European Court of Justice will not be binding on the Federal Supreme Court in Germany, but it is likely to sway the German decision. "If we are not allowed to protect our inventions in Germany, we won't be able to compete in the international market for new disease therapies," says Brüstle.

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