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The term “translational medicine” has come to be widely used in recent years – but what does it mean and why do intellectual property (IP) issues arise?
A simple description is that it is “taking laboratory-based research to the patient’s bedside”. The Wikipedia definition provides a more progressive angle relating to modern medicine:
“Translational Medicine is an emerging view of medical practice and interventional epidemiology, as a natural 21st century progression from Evidence-Based Medicine. It integrates research inputs from the basic sciences, social sciences and political sciences to optimise patient care and preventive measures, which may extend beyond the current provision of healthcare services.”
For example, there is increasing realization that reliance on clinical treatments alone will be insufficient to control rising incidence of conditions such as obesity, diabetes and other diseases associated with lifestyle factors. There is also an increasing need to understand communities where health statistics reveal a common health issue so that the underlying causes can be investigated. An example of this is the high propensity to heart disease in Scotland. This approach involves integrating a study of community health with laboratory-based research, understanding how disease proliferates in the community, and clinical data on the effectiveness of treatments, to inform the development of healthcare strategies. It focuses on preventative, as well as therapeutic, measures and extends to a study of genomics and genetic propensities. It is about developing an understanding across the spectrum from the molecular level to lifestyle and environmental factors.
Translational medicine builds a bridge between clinical research and evidence from community health data. The separate disciplines of clinicians, epidemiologists, and health statisticians are increasingly working together, with policy-makers, to identify how the most effective improvements in health can be delivered, by addressing community issues, in addition to clinical treatment.
Translational medicine poses interesting challenges for the commercial management of IP, as it involves the combined expertise of so many different parties; various university departments, teaching hospitals, NHS Innovations, healthcare and medical companies are all working to innovate in this space. The question of who owns IP becomes a key issue. At one time, a clinical consultant might simply have created a new treatment or procedure and put it into practice. Now, clinicians who are also academics work for a university and for the NHS, and may also be research-funded by a healthcare company; all of these are proactively seeking to own and commercialize arising IP.
CIPM has worked with several organizations involved in translational medicine and has advised in situations where a number are working together, on how the thorny issue of IP ownership should be addressed. This is particularly challenging when the IP issues are not discussed and agreed early on. The key to resolving this is to work out who plans to do what commercially, what rights they will need within that area. It then becomes easier to sort out who should own the IP and how the rights are assigned. If commercial negotiations fail to resolve these issues, then innovations may be dropped or miss their window of opportunity.
The UK has an internationally competitive clinical academic research base, renowned high quality teaching hospitals, and state of the art clinical research facilities. It also has advanced patient databases. Scotland and Ulster are particularly interesting regions in which to run translational medicine projects. Both have large communities where the population has not changed as much as in other parts of the UK. Because there is less mobility, patterns of disease are more easily understood.
The Translational Medicine Research Institute (TMRI) in Scotland is a company focused on commercial interactions with several partners, all working towards commercial outputs. The company is owned by Scottish Enterprise, the Universities of Aberdeen, Dundee, Edinburgh and Glasgow and associated NHS Health Boards.
TMRI was established in April 2006 to create an industry access point and execution vehicle for large-scale collaborations and projects based on the significant translational medicine expertise in Scotland. It is the principal delivery and exploitation vehicle for the Scottish Translational Medicine Research Collaboration (TMRC), a venture bringing together Wyeth Pharmaceuticals with TMRI’s shareholder partners. TMRI’s remit is to deliver and manage £50m of research funding for TMRC projects. The partnership with Wyeth allows funding of clinical trial work, for example developing new technology for biomarkers to detect illness, develop treatment and drugs and drug delivery mechanisms.
CIPM has worked with Scottish Enterprise/TMRI, and also with Durham and Newcastle Universities and NHS Innovations North on commercial IP issues in areas of translational medicine. NHS Innovations hubs stimulate innovations within NHS to make healthcare more effective – for example, measuring urine flow.
We help untangle some of the IP issues and address the key issues for commercialization. Our goal is to clarify what those involved are really trying to achieve and to develop strategies to manage the way through. Our team structure is critical here, combining, as we do, an understanding of a wide range of technologies, including physics, chemistry, biology, engineering and software, with an understanding of business development, IP and commercialisation.
Translational medicine is here to stay and with undoubtedly bring substantial benefits to health care. We are delighted to be playing a role in building confidence that all parties involved in these developments are free to contribute their expertise, reassured that arising IP issues can be managed effectively.
Jim Asher, COO
October 2009
