Court refuses Merck injunction against Clonmel Healthcare

Dispute is over Clonmel’s generic alternative to cholesterol drug ‘Inegy’

The Four Courts. Pharma  giant Merck Sharp and Dohme had last April secured a temporary High Court injunction preventing rival Clonmel Healthcare continuing to sell a version of MSD’s “Inegy” drug. Photograph: Bryan O’Brien
The Four Courts. Pharma giant Merck Sharp and Dohme had last April secured a temporary High Court injunction preventing rival Clonmel Healthcare continuing to sell a version of MSD’s “Inegy” drug. Photograph: Bryan O’Brien

The Court of Appeal has refused to grant an injunction preventing 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) had last April secured a temporary High Court injunction preventing rival Clonmel Healthcare continuing to sell a version of MSD's "Inegy" drug. MSD alleges breach of trademark.

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

MSD appealed that refusal to the Court of Appeal. Clonmel opposed the appeal. On Tuesday the court dismissed the appeal by a two to one majority.

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Mr Justice Michael Peart and Ms Justice Máire Whelan said they would not interfere with the High Court decision refusing to continue the injunction.

Appeal

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 would be 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, used here by about 15,000 people per month to combat high levels of cholesterol in the blood, the main cause of cardiovascular diseases 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.

Mary Carolan

Mary Carolan

Mary Carolan is the Legal Affairs Correspondent of the Irish Times