Private investment in stem cell research stalled; patent applications in China soar: Marks & Clerk

Investment in stem cell technology is growing, but private investment has been affected by increasing controversy and by legal and regulatory barriers, according to a report co-authored in the Cambridge office of Marks & Clerk, the patent and trade mark attorneys.

The Biotechnology Report 2006 says that in the past year there has been a marked shift in the pattern of patent filings in the area of stem cell research, with 24% of patents held by the top 20 organisations belonging to just three academic and government organisations.

It also found that the number of stem cell priority patent filings in China equalled those for the whole of Europe between 2003 and 2005.

The report highlights that over 2,000 stem cell technology patents have been granted worldwide since 2000. Patent activity was 41% higher in 2004 than in 2000. Figures available for 2005 suggest this growth trend has continued.

Report co-author Dr Gareth Williams (pictured), a partner at Marks & Clerk's Cambridge office, said: "The message from our report is clear. Whilst the hostile research environment and controversies that continue to blight stem cell research are not affecting overall investment or the total number of patents filed worldwide, industry has become far more cautious.

"Biotech companies and the venture capitalist community appear nervous, with uncertainties surrounding return on investment and public reception of such research taking their toll on non-governmental investment", he said. As a result, government and academic bodies make up a higher proportion of patent activity than would be expected of a comparably-aged technology.

With these institutions taking the slack, however, growth in the sector shows no signs of stalling. "We may therefore see private investors drawn back in, by the tempting possibility of seizing a share in the estimated $11 billion world market," Dr Williams said.

China

Dr Williams said that stem cell research in China has exploded in the last three years, clearly seen in both filings originating in China (but filed elsewhere) and those filed within the country. This is result of a benign regulatory environment and the significant capital that has been invested in China.

Nonetheless, the data confirmed the US has by far the largest number of priority filings in stem cell research. It accounted for 51% of all applications filed between 2000 and 2005, almost twice as many as China, Australia and Japan combined – which together accounted for 28%.

Within the European market, the report identified the UK as the leader with 35% of priority filings in Europe, a third more than in second-ranked Germany.

Dr Williams said this wasn't surprising because "within Europe, there is currently no single attitude towards the patentability of human embryonic stem cells, whereas in the US it is well-established. The scientific community is continuing to call for more clarity and consistency in the legal status of stem cell research.

"Meanwhile, Europe’s prolonged uncertainty has meant that its academic institutions, governments and industries are effectively forced to file in the EPO without knowing whether their invention is patentable – even in principle. Until this is resolved, Europe is in a situation where it is at a serious disadvantage to the US and Asia-Pacific.”

RNAi sees rush for patents

The report says that RNA interference – the promising technology which allows for the ‘silencing’ of genes – is causing a real stir amongst academics, investors and pharmaceutical companies even though it is still undergoing pre-clinical trials.

Between 2001 and 2003 the number of published patent applications for RNAi technology increased three-fold each year. Marks & Clerk expects this trend to have continued in 2004 and 2005, and into 2006 and beyond.

So far RNAi is dominated by academic and government institutions which currently own 46% of patents. It has been predicted the market will grow to $1.2 billion over the next decade.

5th May 2006

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