Court of Appeal refuses injunction in cholesterol-reducing drug case

The Court of Appeal has by a 2-1 majority refused to grant an injunction preventing the distribution of a generic alternative to a cholesterol-reducing drug at less than one-tenth of its current price.

Pharmaceutical giant Merck Sharp and Dohme (MSD) got a temporary High Court injunction in April preventing rival Clonmel Healthcare from continue to sell a version of MSD's "Inegy" drug over alleged breach of trademark.

Following an urgent hearing at the end of April, the High Court refused to continue that injunction.

MSD then appealed to the Court of Appeal (CoA). Clonmel opposed the appeal.

On Tuesday in the CoA, Mr Justice Michael Peart and Ms Justice Maire Whelan dismissed the appeal saying they would not interfere with the High Court decision refusing to continue the injunction.

Mr Justice Gerard Hogan, dissenting, said the entire case turned on the validity of a supplementary protection certificate extending MSD's patent until April next year. He considered the least injustice is caused by allowing the appeal and granting MSD the injunction.

MSD's main action over the alleged breach by Clonmel of its patent rights has already been admitted to the fast track Commercial Court list.

MSD's plant at Ballydine, Clonmel, Co Tipperary, manufactures the "Simvastatin" active ingredient for "Inegy" which is used here by around 15,000 people per month to combat high levels of cholesterol in the blood, the main cause of cardiovascular diseases and which are the main cause of death in the Western world.

The price at which wholesalers sell Inegy to pharmacies is between €38.45 and €40.98, depending on strength..

Clonmel's "Ezetimibe/Simvastatin" product is sold at a net price of between €3.28 and €3.57.