Companies seeking an extension to their EU-wide drug’s patent protection, should base their calculations on the time of market authorization in Switzerland if that predated approval in the EU. That’s what the European Court of Justice (ECJ) in Luxembourg ruled on April 21.
As a consequence, EU patent protection for some drugs will expire between 6 months and over a year sooner than expected.
The EU, for public health reasons, has limited patent extensions for drugs to a maximum of 15 years after first market approval anywhere within the common EU market. In two similar cases, Novartis of Basel, and Millennium of Cambridge, Massachusetts, had argued that only approval dates in member states of the European Economic Area (EEA) should count, since market authorization in Switzerland does not in any way confer rights to sell pharmaceuticals in the EU.
The highest EU court, however, ruled that the time limits for patent protection do not rely on market access, since even among full EU members approval in one country does not automatically provide market access in others.
The ruling ended confusion over the role of the Principality of Liechtenstein, which automatically recognizes Swiss market approvals. While also joining the EU in a common EEA market, Liechtenstein links Switzerland to the EU on this particular issue, the Court in effect ruled.