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.

Some of this is no doubt a result of an “everywhere” approach adopted by big pharma for blockbuster drugs. However, variation in the numbers of patents validated nonetheless indicates discernment and active decision making even in the least commonly-chosen countries. In other words, the choice of where to maintain patent protection on a country-by-country basis frequently spans the entire potential geographical scope of a European patent.

Secondly, the average number of countries maintained is greater for pharmaceutical patents than for European patents as a whole, and the figures suggest that patent proprietors in this sector are much more likely to choose countries which require translation. In some EPC contracting states (Belgium, Switzerland and Lichtenstein, Germany, France, United Kingdom, Ireland, Luxembourg and Monaco) no translation is required, making validation in those countries effectively automatic.

This balancing of cost to validate and likely market size, both in terms of population and healthcare spend, continues to be apparent in the relative popularity of less commonly-chosen countries. For example, despite a relatively low healthcare spend per person, Turkey is among the more popular selections for pharmaceutical patent holders after the countries already listed, no doubt owing to its population of over 80 million people.

Big pharma

Third, the report obtained EPO data for patents granted in 2018 to selected “big pharma” companies. It is tempting to assume that the largest pharmaceutical companies, having relatively deep pockets and keen to minimise any possible risk of early generic competition, will always validate in all possible jurisdictions.

While not uncommon, this snapshot of data shows that this approach is not universally adopted. Indeed, the picture is broadly similar to that for the pharmaceutical sector as a whole with Germany, France and UK the most popular choices for maintaining patent protection, followed by Italy, Spain and Switzerland (and Lichtenstein), demonstrating that for at least some of their portfolio, preferred countries are selected.

However, there is less variation across the numbers for the remainder of countries available when compared to the rest of the sector, suggesting some foundation to the perception that big pharma is more likely to maintain widespread patent coverage.

The choice of where to validate a European patent remains a tough decision, and one that must always be decided on a case-by-case basis. However, being prepared for the decision (and likely costs) can help to make the process more straightforward for patent proprietors, and to that end, sector-specific data is always useful and interesting.

Sarah Kostiuk-Smith is a partner at Mewburn Ellis. She can be contacted at: sarah.kostiuk@mewburn.com

Image: Shutterstock / Yevgenij_D, Ron Ellis