It began when MSD sued Clonmel claiming the defendant was breaching its 2005 supplementary protection certificate , and extended patent protection, governing MSD’s authorisation for its drug “Inegy”.
MSD disputed Clonmel’s claims. It said once the combination has been the subject of a specific claim in patent, this was a complete answer to Clonmel’s case. However, the High Court rejected a third claim by Clonmel that the SPC was invalid because the marketing authorisation for the combination was not the first marketing authorisation for such combination and the SPC was granted contrary to the provisions of Article 3 of the regulation.
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