Since being handed down, there has been significant debate about the rationale and implications of the ruling amongst the scientific community, lawyers, investors, and those opposed to hESCs and embryo research – and it looks as though the debate is likely to continue for some time yet.
A key area of concern for the development community is that without patent protection, few investors will pay to develop hESC-derived therapies for conditions ranging from neurodegenerative diseases to diabetes, and that therefore the ruling effectively pulls the rug from under their feet.
However, the ruling and the resulting discussion has highlighted and reminded all interested parties that it is still possible to achieve real intellectual property value with, for example, other types of stem cells, in territories outside Europe, and from associated growth media, chemicals and enabling technologies such as processing equipment and delivery devices.
As such, I believe that the Brüstle ruling will have no substantial material impact on the regenerative medicine industry. In fact, there are innovative companies in the sector that are currently, and clearly, demonstrating that value comes in many guises. For example:
- Prof. Pete Coffey at the Institute of Ophthalmology in London and his team are working with industry partners to develop a hESC-based treatment for age-related macular degeneration, a progressive and currently untreatable disease of the retina that causes blindness. Their patents cover the placement of their retinal cells in the eye, not the cells themselves.
- Avita Medical in Cambridge has developed ReCell Spray-On Skin which is a stand-alone, rapid, autologous cell harvesting, processing and delivery technology that enables surgeons and clinicians to treat skin defects using the patient’s own cells. This is a great example of a regenerative medicine technology which avoids the use of hESC.
- Organovo is continuing the development of its NovoGen 3D bioprinter, which uses human cells to print functional human tissue. “The end goal is to print human organs that can be used in transplants,” said Chief Executive Officer Keith Murphy in an interview with Business Week (08/01/12).
As someone who has worked on core technology for the bio-printing of vascular grafts, and on OrganOx’s normothermic organ perfusion device (which maintains organs in a fully functioning state outside the body), I find the Organovo work to be particularly exciting.
Looking to the (near) future, further developments of enabling technologies are likely to come to the fore, such as the delivery of an implant or cell therapy through a retro-injection delivery device, or scale-out autologous and allogeneic manufacture in a ‘cGMP-in-a-box’ system with integrated PAT (process analytical technology). Such developments will provide ample opportunity for parties to secure IP outside of hESC applications and then use this IP to commercialise their science or at least protect it.
This increased focus on enabling technologies has other benefits outside of IP generation and protection. The delivery device (or enabling technology) is the interface between the science and the patient or healthcare professional and therefore its ease of use, simplicity and safety is paramount. And not only from a user preference perspective but also from a regulatory perspective, as regulators such as the FDA look for clear evidence that the device has gone through structured user validation.
