By Maria Nichol
Being responsible for the intellectual property (IP) in a biotech is no small task, not least since our goal is to uncover new disease processes and develop new and innovative molecules which can address these. Our research team is dedicated to identifying new ways of doing all this. If I were to summarize what I do together with my team, I would say our job is to protect the ingenuity and creativity of our scientists. By protecting their innovation, we’re creating a foundation that help us grow as a company and give us the resources, financial and human, to keep pushing down scientific barriers.
Particularly in the era of the Coronavirus pandemic, there is a lot of debate around the ethics of protecting IP for commercial purposes and the impact that has on making therapeutic innovation available to the greatest number of people, fast. I’m afraid to say it is not as black and white as the discussion may suggest. Access to medicines relies on many stars aligning and we, as industry, only control a very small part of the sky. Patenting biotechnology is a matter of great complexity and the exclusivity that we are able to obtain is limited to the innovation that we contribute – typically our novel molecules and their uses.
In fact, one cannot patent anything considered to be a scientific discovery, for instance identifying how a gene interacts in a disease process is considered a ‘natural process’ and is excluded from patentability. This whole interaction between scientific discoveries and application of scientific knowledge to inventions has formed the basis of complex litigation for many years – a particular example can be considered around the non-invasive pre-natal testing technology, where despite it being acknowledged that the scientific contribution was significant, at least in the US, it was considered to be a natural law and not eligible for patent protection. This may be an example from a more distant field, but a large part of what our scientists do – they discover new science every day. And, the majority of these discoveries contribute to advancing scientific knowledge in a universal way. By publishing our findings – and ensuring these are made available to all through our Open Access policy – we are a proud contributor of the global scientific ecosystem.
Those discoveries form the basis of our drug discovery process, whereby we apply our expertise to develop molecules so that they interact in a certain way with the disease targets we have previously identified, and then, drawing on years of scientific experience, we can optimize these molecules, in the end bringing new drugs to people suffering from serious diseases. When we identified the role of the JAK1 pathway in inflammatory diseases, it kick started years of further research and work into how we would turn this scientific finding into a new molecule that can help address debilitating diseases such as rheumatoid arthritis or ulcerative colitis.
Of course, like any research institute, be it public or private, we need to fund our research activity and ensure we can continue to fund it in a sustainable manner, over the long run. Add to that the complexities of bringing new drugs to patients, where we are bound by strict regulatory processes, and have to incur significant costs from all the studies and clinical trials that are required to ensure the drugs are safe and well tolerated, and you get to a very big number quickly.
I referred to the ingenuity and creativity of our teams, and I believe the identification of our Toledo research program, presented last October, perfectly exemplifies this. Our scientists have uncovered a new target class, the salt-inducible kinases, and developed new molecules that act as a potential master switch. This has the potential to restore the immune balance, typically out of control in auto-immune diseases, and is potentially differentiated from existing therapies.
To continue to raise the bar and help our teams deliver scientific and medical breakthroughs, it is essential that we maintain certainty and visibility over how innovation is valued and rewarded, which includes but is not limited to how we protect our intellectual property.