Innovation and health technologies: celling science

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  • SLIDE Within the context of human ESCs biovalue as such is still highly prospective rather than real as embryonic-derived products are still, to use an appropriate phrase, in their infancy. Most as this slide shows relate to the use of hESCs as a source of tissue to test the toxicity of new pharmaceutical compounds, and indeed in the UK, the Medical Research Council and Department of health recently established the Stem Cells For Safer Medicine (SC4SM) programme to fund experimental work to do precisely this. I have listed some of the main centres internationally that are developing these sorts of techniques and products, including one just down the road in Redfern .
  • Within the context of hESC there have been some interesting developments. Here I make a number of important observations about patent activity we have found that reflects the intellectual property response of companies to the moral position taken by the EPO in Munich. The EPO does not make a distinction between embryonic cells as toti compared with pluri-potent. This means that cell lines are seen to be able to generate whole persons, not just specific organs. While in the US The United States Patent and Trademark Office (USPTO) has, to date, granted over 50 patents that claim human embryonic stem (hES) cells in their title and front pages. These include patents on culture methods, differentiated cells derived from hES cells and even hES cells per se . By contrast, the European Patent Office (EPO) has not granted a single patent that makes direct hES cell claims. This reflects the major constraints imposed by the European Patent Convention (EPC), which prohibits the patenting of the "human embryo" on moral grounds As I note here – despite the Federal constraint on hESC research in the US, ironically it is easier to get a patent there than in Europe. One other point to note is that we can see the emergence of patent thickets that serve to secure commercial monopolies in the area: WARF is trying t do this with new IPS cells.
  • This slide simply gives you an idea of patenting by private compared with public (university/research organisation) sectors, here a UK/US regional comparison. It is quite interesting to note that despite the long-standing complaint about British universities being entrepreneurially weak the proportion of patents they are filing is much higher than the US, though in absolute terms is still of a lower number of course.
  • SLIDE – Overall, as Bergman and Graff have recently argued, we can say that the patent landscape is highly complex. ‘ Stem cell lines and preparations, stem cell culture methods and growth factors show the most intense patenting activity but also have the most potential for causing bottlenecks, with component technologies expected to show high degrees of interdependence while being widely needed for downstream innovation in stem cell applications’. This complexity makes for real difficulties among firms trying to secure some niche in the market, especially smaller ones, who have to embark on a considerable amount of cross-licensing to be able to make any headway with their product.
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