Personalisation in life sciences: repurposing drugs and market exclusivity

Personalisation isn't new. In the UK, you can buy Ordnance Survey maps with your home at the very centre. More recently, McDonalds announced a $300 million acquisition of personalisation technology business Dynamic Yield, to tailor experiences based on the time of day and the weather, giving customers more seamless experiences and reducing food waste.

Technology and data know-how mean years of transformative opportunities (and challenges) for organisations when it comes to personalising products and services, from paying taxes to buying dog food. And life sciences are no exception. Indeed, the sector could be said to be an early adopter.

Orphans and SPCs

Personalised drug treatments receive structural support and encouragement from regulators in orphan drug legislation. Orphan drugs are personalised in that as they must treat fewer than 1 in 50,000 people to achieve orphan status. Orphans also receive market exclusivity protection for ten years under EU law.

Less clear is how the application of patents and their extensions – known as supplementary protection certificates (SPCs) – apply to the use of medicines that have been tested and cleared for use for one community, but have a different use and effect on another.

Some personalised drugs have been re-purposed from medicines originally designed for a wider patient group. This can happen where a drug that fails to work for a group sharing particular disease symptoms, is found to be effective for a smaller sub-group within it – the members all sharing what is known as a biomarker. Biomarkers are naturally occurring characteristics – typically genes or proteins – by which a particular pathological or physiological process can be identified.

Aside from orphan drug status, the protection of exclusivity of such drugs by patents may pose a challenge because novelty is a fundamental requirement for a patent, and re-purposed drugs are by their nature, old. The diagnostics needed to identify the presence of a biomarker must also steer around patent exclusions designed to protect doctors from patent infringements when diagnosing patients.

Different applications

The current rules allow SPCs for 'different applications', but it's unclear whether the application is for different disease, or a different group within that disease, or both.

The Court of Justice of the European Union is currently being asked what qualifies as a different application capable of SPC protection. The answer may define whether SPCs can extend to drugs directed to sub-groups with a biomarker. If they can, it will have significant impact on exclusivity incentives for developing personalised medicines, as well as funding, investment and research.