China vs. U.S. on Cancer Gene Therapy IPR

Read "To China For a U.S. Cancer Drug? Researchers Say Gene Treatment Was Stolen and Rushed to Market" by Ariana Eunjung Cha, The Washington Post, July 5, 2007.

SiBiono GeneTech is now marketing Gendicine, a cancer drug which works by replacing genes in the cancerous cells. Peng Zhaohui, founder of the Chinese firm which created the drug, put it on the market in the breakneck span of seven years. The "chief executive of Introgen Therapeutics of Austin, said SiBiono's drug is the same one that he and an American colleague developed 15 years ago. He said that while Introgen's drug was making its way past U.S. research hurdles, SiBiono stole the technology and rushed it to market, thereby infringing on Introgen's patents......Peng, a former University of California at Los Angeles medical researcher, denies that his company is infringing on any patents held by Nance's company.....As of last month, more than 5,000 patients had been treated with the drug." Gene therapy research in the United States is subject to extensive ethical review and new drugs have to demonstrate safety and efficacy through extensive trials prior to approval. Gene therapy will only work on some patients and there are other therapies available for cancer patients; both of these factors make the approval process longer. "Introgen says it holds 258 worldwide patents, four of them in China. No lawsuit has been filed. Nance declined to comment about specific patents or to describe the company's Chinese patent position in detail, citing possible future litigation." The article suggest that the situation poses a threat to U.S. (and other multinational) research intensive pharmaceutical firms which depend on patent protected innovations to enable global sales of their products at relatively high prices.

Comment: I am more concerned with delays in making potentially life saving treatments available to large numbers of people who could benefit than I am with the profits of multinational pharmaceutical firms, which will in any case invest in Chinese facilities and research if that is the way to more efficiency. A really good system to track and analyze possible adverse reactions to pharmaceuticals and more funding and reform of the U.S. Food and Drug Administration drug licensing processes would help to speed the process here.

I know that people are adverse to risks that are new and poorly understood. I also know that there are irrational concerns with anything involving the introduction of new genes in our cells. I hope that in spite of these fears we can make rational decisions to accept a reasonable amount of risk in research where there is a reasonable expectation of large gains from the research.

I find it hopeful that 5,000 people have been treated with this gene therapy, many under the supervision of Chinese experts who once worked at Johns Hopkins and UCLA. Perhaps there is real potential in gene therapy.

On the other hand, from what I read in Science, human genetics is much more complicated that we thought 10 or 20 years ago. A lot of the DNA in our chromosomes that was once thought to be junk seems to code for RNA that has direct function in cells rather than simply guiding the production of proteins. There also seems to be a lot of complexity in the numbers of copies of genes, and the ways in which DNA on the chromosomes is cut and pasted into genes.

It is almost certain that as scientists develop better understanding of micro-biology and genetics, as better tools are developed for gene sequencing, and better gene therapies are developed we will see huge progress in medicine (and indeed in agriculture, industrial biological processes and other technologies). It may take longer and more work that was once expected, however, to see these technologies in full flower.

In any case, kudos to the Chinese for their guts in going forward a full throttle with this exciting work! JAD