Ban on stem cell patents which involve destroying human embryos

In what could hit the field of medical research, Europe’s top court has banned patenting any stem-cell process that involves destroying a human embryo. While researchers have called this a “regressive” step, ethicists are happy with the decision.

The judgment follows a case filed by non-profit Greenpeace against a German scientist, Professor Oliver Brüstle, who serves as professor of reconstructive neurobiology at the University of Bonn Medical Center in Germany. He held a patent (obtained in 1991) for a process that can convert human embroynic cells into nerve cells. The stem cells were extracted at the blastocyte stage. The technique can be applied for the treatment of several degenerative brain diseases, including Parkinson's.

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Greenpeace had contested Brustle's patent in 2004 at a German court saying that the patent was immoral and violated the 1973 European Patent Convention which honours human dignity and puts restrictions on commercialisation of human life. Moreover, the concept of “human embryo” was not defined in the directive of the European Parliament. The watchdog also sought clarity on the definition of “human embryo”. The patent was considered invalid by the court and Brustle's filed an appeal in the Federal Court of Justice in Karlsruhe, from where the case was moved to the European Court of Justice.

In a statement released on October 18, the European Court of Justice said, “The Court considers that any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ if that is such as to commence the process of development of a human being. A non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis (A form of asexual reproduction where growth and development of embryos occur without fertilisation by a male ) must also be classified as a ‘human embryo’.” It added, such “organisms” are not fertilised, but they are capable of starting the process of the development of a human being.

Ethics V cure Stem cell treatments are subjects of controversy around the world. Stem cells are cells which can multiply infinitely and scientists are exploring this property in contriving cures for diseases like cancer and Parkinson's. However, most stem cell therapies are in research or clinical trial phase. The issue surrounding ethics arises from a pro-life argument that a human embryo has potential to become a human being and cannot be exploited for research purposes. Stem cells are derived from surplus in vitro fertilised eggs donated by infertility clinics. These embryos are eventually discarded, but opponents of stem cell research argue that destroying embryos for research is equivalent to cruel treatment of adult human beings. Stem cell research has faced similar ethical bottlenecks elsewhere in the world. Former president George W Bush had banned federal funding of stem cell research in 2001, sending stem cell labs across the country into dismay. But his successor, Barack Obama, overturned that ban in 2009 and pledged not to leave any stone unturned in aiding the research. Promising as it may be, stem cell research is far from being used in hospital settings to save lives yet. Even in the US, which is at the forefront of this research, use of stem cells in practical settings is limited. At present, they are mainly used in bone marrow transplants.

The European Court thus concluded that scientific research entailing the use of human embryos cannot access the protection of patent law. The court ruled that the use of stem cells from human embryos is “immoral” and violates human dignity.

However, the ban does not apply to research that applies to the human embryo. For example, processes that treat a malformation in an embryo and improve it's chance of survival. The ban will not affect patenting of research techniques involving adult stem cells as well.

The Scientific community has strongly opposed the move. “We are saddened to hear that the European Court has chosen to make it far more difficult for those in the EU to benefit from the fruits of stem cell research,” says B D Colen, spokesperson for The Harvard Stem Cell Institute in the US.

We have little doubt that this exciting field of research will eventually produce treatments and cures for diseases that affect millions of people, he adds.  “By banning the patenting of stem cells and treatments derived from embryonic stem cells, the court makes it difficult if not impossible for pharmaceutical and biotech companies to introduce treatments in EU countries,” he notes.

Swathi Sundarraj, research scientist with Stempeutics, a Bengaluru-based firm that researches stem cells, concurs. “This is definitely bad for science as it will make it difficult for research to be translated to clinical settings. A huge proportion of money to translate research to clinical settings comes from pharmaceutical companies.

If they can't profit from research, they're going to back out.” Sundarraj adds that human embryonic cells are essential to understand degenerative diseases. Their regeneration potential is greater than adult stem cells.

But the move has been welcomed by opponents of stem cell therapy.  “By blocking the patenting and commercialisation of human embryos, the European Court of Justice (ECJ) has strengthened the protection of human life against commercial interests within the EU," says Lasse Bruun senior campaigner with Greenpeace. “We hope that national patent offices follow the ECJ decision, by not granting patents on human embryonic cells.”

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