Got a patent, now where to validate?

For smaller companies and universities, deciding where to validate a pharma patent can be difficult. Sarah Kostiuk-Smith of Mewburn Ellis looks at the options within the European Patent Convention countries.

Securing a European patent covering your drug candidate, or a potentially valuable formulation or dosage regimen, is certainly cause for celebration. However, it necessitates a big decision: where do you validate your new patent? That is, which of the 38 European Patent Convention (EPC) countries spanning from Iceland to Turkey will you select for the patent to be effective and enforceable?

Crucially, the decision must be made in a relatively short timeframe—the deadline for validation is three months from grant of the European patent and where translations are needed these can take a while to prepare and so must be ordered well in advance of the deadline. Once that deadline expires it is not possible to expand your selection, so the decision needs to stand the test of time as, hopefully, your product leaps from success to success until it reaches the clinic and companies are potentially acquired, raise funds or even launched on a stock exchange. 

It is therefore tempting to simply say “everywhere”. However, for many patent proprietors, whatever their size, costs preclude an “everywhere” approach and the list of available countries must be filtered and a subset selected.