We have extensive experience of developing IP strategies for protecting the use of biomarkers to characterize patients and determine the best drug treatments. Indeed, we have shaped the case law that makes the European Patent Office such a favourable forum for protecting these inventions.

We understand the challenges in this area and can advise you on how to adapt your IP strategy to deal with these. From biomarker discovery through to clinical approval, personalised medicine inventions can change significantly, so it’s important to build an IP portfolio that can flex and grow as the technology develops.

The challenge of a rapidly developing technology challenge is compounded by a complex international landscape around diagnostics. For example, while the European Patent Office is a very favourable jurisdiction for protecting inventions in the precision medicine space, over the last few years the USPTO has become a much more difficult forum (following the US Supreme Court’s 2013 Prometheus and Myriad decisions). We work with trusted international partners to shape strategies with the best chance of success.

We also appreciate that methods of diagnosis are increasingly performed across international borders, with samples sent internationally to centralised processing facilities and data flowing between jurisdictions. This can cause difficulties in enforcing patents and should therefore be considered carefully at the early stages of the patent process. We recognise the importance of understanding how the technology will be implemented and can work with you to design an IP strategy which will reflect and protect the situation in the real world.

Read more on our Precision Medicine spotlight page.