Merck Canada patent protection in Portugal has expired, says ECJ

Published: 17-Mar-2014
Regulatory

Maximum duration of protection is 15 years court rules


Pharmaceutical manufacturers in the European Union (EU) can only protect their active ingredients against exploitation by generic manufacturers for 15 years, even when securing patent protection expiring at a later date. The European Court of Justice (ECJ) has ruled that the maximum combined duration of protection gained from patents and supplementary protection certificates approved during patent applications is 15 years.

Merck Canada had claimed a patent for montelukast sodium, used in asthma treatments Singulair and Singulair junior, acquired in Portugal on 2 October 1998, could last beyond 2012, even though the first marketing authorisation was awarded in Finland on 25 August 1997. The ECJ disagreed, saying the clock started ticking that year, 'irrespective of the date on which the basic patent was granted'.

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