Wednesday, October 19, 2011

WSJ, 10.19.2011

Patent Ruling Sets Back EU Stem-Cell Scientists

Europe's top court ruled Tuesday that any research involving the destruction of human embryos can't be patented, a decision that deals a blow to scientists on the continent but gives an edge to those in the U.S. and other countries.

The ruling by the European Court of Justice doesn't prevent scientists from experimenting with cells plucked from human embryos—which destroys the embryo—but it removes a key commercial incentive for biotechnology and pharmaceutical companies to back stem-cell research in Europe.

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Kristin Martins-Taylor holds a container with stem cells at the University of Connecticut.

Stem cells obtained from embryos can become all other cells in the body, which makes them a potential tool for repairing and regenerating diseased organs and tissue.

"Companies now will not invest in these technologies because they cannot safeguard their investment" through patents, said stem-cell researcher Oliver Bruestle of the University of Bonn, in an interview following the ruling. The case centered on a technique he invented to make nerve cells from human embryonic cells. "It's a bitter pill for all of us to swallow."

Dr. Bruestle's 1997 patent was challenged by Greenpeace in Germany on the basis of a European Union directive banning the patenting of inventions whose commercialization violates public order or "morality." A German court then decided Dr. Bruestle's patent was invalid. After he appealed the decision, Germany's federal court referred questions about the case to the European Court of Justice in Luxembourg. An advocate there handed down a legal decision, and this was largely upheld on Tuesday. There are no further legal appeals available to Dr. Bruestle.

Greenpeace has long argued that patents should only be granted to human inventions, and has opposed patents on plants, animals, genes and smaller parts of DNA.

"We're not against research on human embryonic stem cells," said Christoph Then, a spokesman for the group. "But this involves the commercialization of the human body, which we are against."

Stem cells are typically derived from 80-to-100-cell embryos—each the size of a pinhead—that are left over from fertility treatments and donated for research. For some people, the destruction of embryos in the extraction of stem cells is tantamount to destroying a human life.

The latest decision means that techniques invented by scientists in Europe involving human embryonic stem cells can now be safely copied by rival scientists without fear of violating European intellectual-property laws or having to pay licensing fees. European scientists can still get patents to protect their work in non-European markets. Patents awarded outside Europe are unaffected by the decision.

Scientists outside Europe said the ruling could help researchers in the U.S and elsewhere who are also working on embryonic stem-cell science. "Of all the intellectual work being done in Europe, if something is successful it will now be [commercialized] by a company outside Europe" where patent protection is available, said Robert Lanza, chief scientific officer at Advanced Cell Technology Inc. in Marlborough, Mass. "Europe is basically exporting its research—it is unfortunate."

The ruling could deter companies from investing in European labs that work with human embryos.

The decision comes at a time when embryonic stem-cell research, long a controversial field, is starting to attract commercial attention from biotechnology and pharmaceutical companies operating in Europe.

Next year, for example, Pfizer Inc. and scientists at University College London, hope to begin a human trial in the U.K. using embryonic stem cells to treat age-related macular degeneration, a common problem in the elderly that can cause blindness.

"We keep a close track of pertinent rulings and are aware of this one," a Pfizer spokeswoman said.

In September, Advanced Cell Technology received U.K. regulatory permission to use a product derived from human embryonic stem cells in a human trial for Stargardt's macular dystrophy, a rare condition that can cause vision loss. The company says its work in Europe won't be affected by the latest patent ruling because it involves cell lines created from a very early stage embryo—eight cells in size—in a way that doesn't destroy the embryo.

The legal ruling is likely to hit scientists in the U.K. and Sweden especially hard, since they own a large chunk of stem-cell-related patents in Europe. Researchers in the two countries together own more than 100 such patents, according to Dr. Bruestle. His own lab has converted human embryonic stem cells into nerve cells, which have been genetically changed to release a particular substance that inhibits epileptic seizures.

Dr. Bruestle now intends to see if such human-derived cells can stop seizures in mice. If successful, he might move on to human trials.

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