The right recipe for the repurposing omelette

Big Pharma is looking for solutions to the COVID-19 pandemic wherever it can find them, so drug repurposing is more important than ever, as research lawyers Jakob Wested and John Liddicoat argue.

The repurposing of drugs that have been approved for treating other viruses has gained unprecedented media attention during the COVID-19 pandemic. Lawyers persistently criticise second medical use patent claims as pointless, yet pharmaceutical companies continue to obtain and litigate them. Second medical use patents are probably valuable only occasionally and if standing alone, they are an unstable foundation for a business model. 

The EU regulatory system provides incentives for repurposing. When a drug is authorised for the first time, the authorisation holder receives eight years of data exclusivity that runs concurrently with ten years of market protection. These two exclusivities are often summarised as 8+2, with the 2 referring to the two years remaining of market protection (after the expiry of data protection).

There’s a specific incentive for companies to repurpose drugs: market protection will be extended to 11 years if, within eight years of authorisation, the drug is repurposed to treat a new indication that brings a significant clinical benefit compared to existing therapies.