Good news for stem cell patents in German Brüstle ruling

In October 2011, Europe's highest court decided that a process that involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.

It was ruling in a case referred to it by a German court, which asked the judges in Luxembourg to decide what is meant by the term "human embryos" in Article 6(2) of the directive on the legal protection of biotechnological inventions. In particular, it wanted to know whether the term embryo included all stages from the fertilisation of the ovum. It also asked what is meant by the expression "uses of human embryos for industrial or commercial purposes".

The case stems from a challenge launched by environmental campaign group Greenpeace against an application filed by research scientist Oliver Brüstle in 1997. The application related to his research work on isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases. Greenpeace claimed the patent was invalid because it covers processes for obtaining precursor cells from human embryonic stem cells.

Following the ruling of the Court of Justice of the EU, it was left to the German courts to decide on the patentability of Brüstle's work.

On Tuesday, the country's Federal Court of Justice ruled that Brüstle's patent DE19756864 could be maintained in amended form, overruling the German Patent Court's finding of partial invalidity at first instance.

In particular, the Court said it was satisfied that a general disclaimer excluding the destruction of human embryos would render inventions relating to human embryonic stem cells patentable.

Paul Chapman of Marks & Clerk described the ruling as "good news for bio-medical researchers worldwide".

"According to the German Federal Court, because stem cells do not have by themselves the capability to initiate the process of developing into a human being, they cannot be treated as human embryos per se. This means that, save when stem cells are harvested by destroying human embryos, cells derived from human embryonic stem cells can be patented."

He added that the decision could prompt the EPO and the UK IPO to consider revising restrictive guidelines they drew up in the wake of the Court of Justice's decision that banned patents on stem cells derived from blastocysts altogether.