There are at least two IP developments going on in the EU presently that are of great importance to the medical devices industry. First, there are the developments toward a single EU patent, a lengthy process to say the very least, which seems to be arriving at an important step. Secondly, there is the consultation about the revision of the EU IP enforcement directive, the EU instrument that prescribes to the EU member states how they should organise IP enforcement tools for IP rights holders.

The important step that the EU unitary patent has arrived at is that the EU Legal Affairs Committee approved use of the enhanced co-operation procedure to create a unitary patent system in the EU, as requested by 12 Member States last year, on 27 January. If Parliament as a whole and Council authorise this use of enhanced cooperation (the European Parliament as a whole will vote on the proposal during the February Strasbourg session and the Competitiveness Council will examine it on 10 March), the Commission will have to table two legislative proposals – one on the language regime and the other establishing the single patent. This will allow the EU member states in favour of a single EU patent to move forward with it, while those that still object to the proposal (language problems have proven the most difficult to resolve as member states are reluctant to allow patent to be in other languages than their own). With patent being especially important to companies in high tech fields such as medical devices companies, it hurts EU competitiveness if patents are much more expensive to obtain in the EU than elsewhere, one could say prohibitively expensive. It has been calculated that with the whole European (EPC) geographical area covered a patent would cost at least 15 times more than in the US for coverage of the whole EU. A European patent validated in 13 countries can cost up to €18,000, of which nearly €10,000 goes to pay translation fees alone, making a European patent 10 times more expensive than a comparable US patent. Hopefully the Commission’s proposals will bring the costs of EU patents down to acceptable levels, but it will still take time before these proposals would finally be implemented.

The second important development concerns the Commission’s plans to revise the EU directive on the enforcement of IP rights in member states. The European Commission has launched a public consultation on 11 January 2011 on the findings of a report assessing the application of Directive 2004/48/EC on the enforcement of intellectual property rights in the Member States. The report shows that certain provisions of the Directive have given rise to different interpretations and application in practice across the Member States. Furthermore, it addresses the extra, challenging dimension to enforcing intellectual property rights that the Internet and digital technologies present. Also, the report concludes that

“Other issues that could need special attention are the use of provisional and precautionary measures such as injunctions, procedures to gather and preserve evidence (including the relationship between the right of information and protection of privacy), clarification of the meaning of various corrective measures, including the costs of destruction, and calculation of damages.”

This latter point will be of particular significance to the medical devices industry, as counterfeit medical devices pose an increasing problem in the EU. Although the Commission had an impact assessment carried out on among other things it has not yet followed up on one of the recommended actions of the assessment:  a directive dealing with counterfeit like the one in the works for medicinal products. Improved instruments for removing counterfeit devices from the market proposed by the Commission, also when not in possession anymore of the party sued for infringement, would benefit the medical devices industry greatly. Otherwise even after a judgment finding infringement, the authorities might still need to issue warnings like this one and patients could not be sure that the devices used on them are actually safe.

This consultation ends on 31 March 2011. Any companies interested in responding: if you would like assistance, I will be happy to help.