BioWorld International Correspondent

PHILADELPHIA - Investment in stem cell technology is growing rapidly despite widespread public controversy and the many and varied regulatory, ethical and legal barriers it faces, according to an analysis of patent activity.

Worldwide, more than 3,000 patents related to stem cell technology have been filed since 2000. Overall, patent activity was up 127 percent in 2003 over 2000, and had it not been for a snafu at the European Patent Office the number of applications would have risen further in 2004.

"The industry is clearly taking the view that countries will adopt a more liberal approach once the potential contribution that stem cell research can have in furthering the cause of medical science is more widely understood," said Claire Irvine, a partner at Marks and Clerk, a firm of patent and trade mark attorneys based in London that compiled the report.

According to the report, which was launched here at the BIO 2005 convention, the UK had the highest number of first filings in stem cell research in Europe between 2000 to 2004, accounting for 31 percent. The U.S. dominates worldwide, with four times as many first filings as Japan, Australia and the UK together.

Those figures are contrasted with bio-nanotechnology, a field at a similar stage of maturity, but with minimal regulatory constraints, which saw an increase of 134 percent in patents filed from 2000 to 2004.

Biotech companies are undeterred by the hostile research environment that currently governs the stem cell sector, according to Irvine. "The market is sure that there is potentially a huge revenue stream from stem cell research."

With the worldwide market currently valued at $2.7 billion, and set to grow significantly, biotech companies want to protect their R&D investments as much and as far as regulations will allow, Irvine said.

The UK's dominant position in Europe is fueled by a liberal regulatory framework. But Irvine pointed out that in the absence of a unified European approach, patents registered by the UK Patent Office may not be enforceable elsewhere in Europe.

"If this discord continues, Europe and the UK could fall further behind the U.S. as well as Asia, where China, Singapore and South Korea are all benefiting from government investment and greater clarity in patenting regimes."

The report also highlights China's emergence as a force in biotechnology intellectual property. The Chinese company Shanghai Biowindow Gene Development was granted the highest number of patents in cancer therapeutics from 2000-04, with Bayer AG in second place and another Chinese company, Shanghai Gene Development, in third place. Overall, China had the fourth largest number of bio-nanotechnology filings in the world and the seventh largest number in stem cell research.

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