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by Aaron Thalwitzer

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

The stem-cell researcher in question is straight pissed off.  Even though the preliminary opinion will be reviewed in a few months by the full court, such opinions are rarely overturned.

“It’s the worst possible outcome,” says sad-faced scientist 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.

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.

The EU’s guidelines on biotechnology patenting are hazy when it comes to techniques involving cells derived from human embryos.

Despite being a preliminary opinion, it create patenting issues for researchers in other European countries.

Legislation on stem cell research varies across Europe. Ranging from liberal to restrictive to undetermined (e.g. Ireland doesn’t have a law on point). None of them have had their laws fully flushed out, and they will certainly refer to the European-level court for guidance.

The opinion concludes that pluripotent stem cells cannot be defined as embryos because “they are no longer capable of developing into a complete human being” but adds that the embryonic source of pluripotent cells“cannot be ignored”. The ECJ reasoned 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”.

Obviously, the opinion is likely to influence other European countries to enact restrictive laws or even complete bans. The scope of a patent is defined by what that patent claims, not by outside issues.

Not even the final opinion of the ECJ binds the Federal Supreme Court in Germany, but it is highly persuasive. The interested researcher invokes fire and brimstone in criticizing the decision, saying, “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.”

It’s important to remember that the European Patent Office restricts patentability of methods of medical treatment, so this decision is less significant than if it were made by a U.S. Court. An public interest-focused approach is more common in the rest of the world than the United States. The USPTO has already upheld hES patents.

The ECJ’s press release is available here.