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High Court, in patent infringement proceedings, upholds defendant's counterclaim challenging the validity of the plaintiff's patent rights to a cholesterol treatment drug under a supplementary protection certificate, on the grounds that the drug's two 'combination' active ingredients was not an independent innovation or invention covered by the patent in question, and in those circumstances the certification is invalid and must be revoked.
Infringement of patent rights under supplementary protection certificate ("SPC") - judgment on counterclaim challenging validity of SPC - three issues - whether SPC breaches SPC regulation - whether SPC invalid where contained substances protected by earlier SPC - whether a subsequent marketing authorisation means SPC granted contrary to SPC regulation - Irish patent for treatment of atherosclerosis - provisions of SPC regulation - separate invention - development of cholesterol treatments and combination therapy - relevant terms of prior patent and nature of invention - whether once combination has been subject of a specific claim in a patent that is a complete answer to claims of invalidity - purpose of additional period of exclusivity to encourage research and compensate - teva v gilead test - whether product falls under invention - account of prior art at filing or priority date of patent - role of 'skilled person' in consideration of issues - expert evidence of organic chemist - combination per se not an innovation of patent - combination not an invention covered by patent - SPC declared invalid - case not made out that particular combination should be regarded as authorised by prior marketing authorisation - SPC revoked
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