Prostate Cancer UK is a relatively young charity in terms of research funding. Up until around 2012, we were spending a maximum of £2-3m per year and, like most small research-funding charities, we were spending that budget on early stage discovery research. In 2012 the charity committed to becoming more focussed on funding research that could make a difference to men with prostate cancer. That renewed focus, and a larger budget for research, have enabled us to think and do things a bit differently.
At a recent AMRC masterclass I heard from a number of charities who are exploring exciting new ways of funding research. While there were a range of approaches, the thing that they all seemed to have in common was that they were designed to enable each charity to diversify away from funding only discovery science through response-mode schemes and specifically to support translation of promising results toward eventual patient benefit.
It seemed that all of these exciting new schemes were in addition to the regular response-mode approach to funding discovery research. In my opinion that is exactly the right thing to do. It’s important to continue to create new knowledge to feed the start of the pipeline at the same time as taking the most exciting discoveries forward toward the ultimate goal of patient benefit. However, the barrier to wider adoption of these exciting new ways of funding might, therefore, be the need for significant additional expenditure required to support them.
At Prostate Cancer UK we’ve tried a couple of different ways to support the more translational type of research that might allow us to extend our portfolio but with a less extreme increase in expenditure. Firstly, we ran a couple of targeted calls for proposals for translational research, and more recently we have redesigned our annual response mode round to make it fit for purpose to support BOTH discovery and translational research.
What’s this got to do with Intellectual Property?
Funding this kind of research requires some changes to how we deal with intellectual property. Up to now I think that we’ve only ever really considered IP in terms of new foreground IP. Foreground IP is intellectual property that is newly created through the work we fund. However, as we move into more translational spaces the IP is likely to exist already at the point of award – so called background intellectual property. We need to make sure that we pay as much attention to the background IP as we would to foreground IP and I’m not sure that, as a sector, we’ve quite grasped the different challenges and the fact that our current terms and conditions are too focussed on the foreground to work for the background.
There might be something in the background (IP)
The terms and conditions that are used by many charities at the moment are not perfect but they do a decent job at making it clear to universities that they will own any new foreground IP but that the funder(s) expect to share in the benefits if that IP is commercialised. Some issues remain about identification of all funders who have contributed, and how they are brought into discussions about the process of commercialisation, but broadly everybody expects the same thing.
Unfortunately, in our experience, those terms and conditions don’t really work for translational research where the IP is background. I think the root of the problem is that the standard terms, and especially the “IP must be owned by the institution” clause, are clearly impossible when the IP already exists and is owned by a company. As a result, the principles behind the policy and especially the principle of shared rewards, end up being ignored. To illustrate why this is a problem, take an example of funding a first-in-man trial of a drug owned by a company. That investment de-risks the development process for the company and adds significant value to their asset. The goal for the funder is to get that treatment to patients rather than any commercial benefit, but if we add value then we should share some of the reward when the commercial benefit is translated into revenue.
What can we do differently?
Prompted by some rather difficult conversations with companies, and in committee meetings, we decided to change our application forms and our terms and conditions to improve how we deal with this kind of situation. We want to be able to identify, at application stage, those grants with significant background IP involved so that we have a head start on the grants likely to require IP negotiations. We also want to ensure that applicants have understood the difference between foreground and background IP and how each might impact on their research plans. Finally, we are hoping that the changes we’ve made will make clear our expectation that we expect to enter into discussions about revenue share or royalty payments if we felt that our funding is enhancing assets held by third parties.
A before and after shot of the IP section of our application form (can you guess which is which?)
It’ll take a bit of time to work out if the changes we’ve made have achieved all of these goals. However, from the first round of applications to come in on the new forms it’s already clear that we are managing to identify issues, and generally get better explanations of the IP situation, at application stage. In truth, the big battle is the one to make owners of existing IP understand and expect to reward non-commercial funders who have funded translational or clinical research using their assets. For this to become the norm, in the way it has for universities in the more traditional IP creation / discovery research space, will probably take a sector-wide approach. I believe that treating background and foreground IP separately is an important first step towards that goal. If we can get good deals in place for supporting translational research then not only will we have moved research a step closer to patient benefit, we will also be able to use the revenue those deals generate to fund even more excellent research in future.