Graham Dutfield: As drugs become more precise, so needs the patent system

Transformation in Trials

We speak to Graham Dutfield, professor of International Governance and author of That High Design of Purest Gold on the evolution of IP regulation in Pharma and how it could be transformed in the future.

Patents are a historic tool, but have undergone an evolution. Patents started out in the 1470’s in Venice, and as an example Christoffer Columbus had a patent to explore the new world. Only in the late 18th century did patents become associated with exclusive rights to exploit an invention in return for disclosing the recipe for it.

The purpose of patents is to incentivise companies to take on the considerable risk and heavy investment in researching and developing drugs. Without patents, competitors could replicate a successful drug without having to take on the investment and risk.

But even though the intention behind patents is to ensure further innovation, it also creates perverse incentives in life sciences. This is mainly because new uses of existing drugs can also be patented as well as human genes and other biologics.

We speak about how the biotech revolution changes the patent landscape by introducing complex technologies that require multiple patents to ensure protection to reap the benefits of the investment in their development. The industry is changing with a rise in the sheer volume of patents on both the drugs themselves, but also the manufacturing methods.

The professionalisation of invention - the intententive pursuit of invention - was in fact the greatest revolution of the pharmaceutical industry. We look back to the history of the pharmaceutical industry and how the centre of gravity changed from originally being centred in Germany, but moving to the UK and eventually the US - shaped by the world wars.

When turning to the future, we speak about the importance of biomarkers. They have the potential to transform medicine that works mediocre in the broad population to working exceptionally well in a specific subset of the population. There are also more approvals of novel drugs than in previous decades.

But there is still an issue with a lack of research in diseases in underserved populations as well as rare diseases, where the market for the drug may be small. The potential for technology transfer is also still unutilized, and getting this right might help us prevent another pandemic.

Graham envisions a menu of incentive structures for different kinds of disease areas that may differ for areas like chronic pain, antibiotics or rare diseases. That would be a more precise tool for getting the kind of invention we want in areas, that may currently be outside of the reach of patents.

Guest:

Graham Dutfield: https://www.linkedin.com/in/graham-dutfield-2013a91b5/

That High Design of Purest Gold: https://www.amazon.com/That-High-Design-Purest-Gold/dp/9811222479

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