Got a patent, now where to validate?
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.
In our experience it is common for larger companies with extensive patent portfolios to have lists specifying sets of countries for a given set of circumstances, but without such a backdrop the choice can feel daunting for smaller companies, SMEs and universities. The choice typically factors in costs, business interests, likely markets and market size, possible manufacturing and import locations and the regulatory framework in Europe, in addition to a healthy interest in what others in the sector do in a similar scenario.
To help patent proprietors and applicants facing these decisions, Mewburn Ellis has prepared a “ Special Report: Validation Strategies for Pharmaceutical Patents in Europe”, mining publically available data and drawing on its own experience. The analysis reveals a number of interesting trends in the pharmaceutical sector.
Expansive validation strategies
The first is that, in general, far more expansive validation strategies are adopted in this sector than for European patents as a whole. While the majority of European patents, when considered across all technologies, are maintained in only a small number of countries, when patents are filtered to the pharmaceutical sector the spread of countries selected is greater. This is particularly noticeable for the less-commonly selected countries. For example, European Patent Office (EPO) data from 2018 show that in 18 of the available 38 EPC countries less than 5% of patents across all technologies were validated there.
Analysis of a random sample suggests that for many of those countries, the proportion of pharmaceutical patents validated was double that. Indeed, the figures suggest that the patents in the pharmaceutical sector may account for a substantial proportion of European patents enforceable in some of those countries.
