Europe boosts stem cell patent rights

Stem cells produced by Carlsbad's International Stem Cell Corp. can be patented, a European court ruled Thursday. The decision allows the biotech company to get patents for its stem cells made from unfertilized, or parthenogenetic, human egg cells.

In related news, the company said Thursday it plans to apply by the end of the year to do a clinical trial of a Parkinson's treatment derived from its parthenogenetic cells.

The trial should begin in a couple of months, said Simon Craw, the company's executive vice president of business development. The company will need to raise about $5 million for the trial, he said.

International Stem Cell is developing these cells as an alternative to human embryonic stem cells, which many regard as morally wrong. Moreover, the parthenogenetic cells have a reduced tendency to cause immune reactions when transplanted, which could make them an attractive use for therapy.

The European Union forbids patents on the use of human embryos, the source of embryonic stem cells. Patent applications in the United Kingdom and other countries for parthenogenetic cells have been held up because dividing parthenogenetic cells resemble embryos.

However, the Court of Justice of the European Union in Luxembourg ruled that parthenogenetic cells are not embryos, so cells made from them are eligible for patenting. While the structures look like embryos, they stop growing in a few days and die.

"In today’s judgment, the Court holds that, in order to be classified as a ‘human embryo’, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being," the European court said in a press release. "Consequently, the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a ‘human embryo’."

Shares of the company closed after the decision at 8 cents, up 1 cent for the day.

The decision is a great turning point in the legal struggle to patent parthenogenetic stem cells in Europe, Craw said.

Craw said the decision "is a clear case of the law catching up with the science."

ISCO already has patents on the cells in the United States, Craw said, and the European decision helps solidify the legal status of parthenogenetic stem cells.

The next step is for the company to ask the United Kingdom to grant patents for the cells, said Lisa Haile, an attorney with the San Diego office of DLA Piper who worked on the case for International Stem Cell. The UK government had earlier balked, but didn't entirely rule out the request. Now the European court's decision should tip the balance.

Haile said the UK and other governments have the legal right to make their own decision, but the European court has great influence.

Haile said the decision was well-reasoned because it considered the parthenogenetic cells as they exist, not the effect of hypothetical improvements in technology that could potentially make the cells develop into full-term babies.

The decision was also personally satisfying because the case had gone on for a long time, Haile said.

"I first filed these patent applications in 2005," Haile said. "It's been a long, long haul for us and the company so it's really exciting."

However, Rev. Tad Pacholczyk, director of education for the National Catholic Bioethics Center in Philadelphia, said that the moral status of human cells created by parthenogenesis is "unclear."

"My view would be that if these grow as organized embryos for the first few days and then arrest, they may just be very short-lived human beings," Pacholczyk said. "When genes are not properly imprinted, the organism tends to be severely compromised, and will likely develop only to a certain point, and with serious defects. Another reason for thinking that parthenotes may be defective embryos is that they produce blastocysts that appear to be very similar to those of normal embryos. A blastocyst is a particular stage of an embryo, about 5-7 days of age, in humans."

"The issue here is, in my opinion, that if we are not quite sure whether it might be a human being/human embryo at a very early stage, but we have some grounds for suspecting it could be, we should exercise caution. If the noise rustling in the bushes might be a human, we shouldn't shoot our gun into those bushes."

Meanwhile, preparations continue for the Parkinson's trial, Craw said. Patients will be treated at two sites, one in North Carolina in collaboration with Duke University, and another in Australia. Those eligible will have mild to moderate Parkinson's disease. When the trial is ready to begin, information will be available at International Stem Cell's Web site.

The trial will primarily look for safety, Craw said, and secondarily for signs of effectiveness.