Sale of rival MSD cholesterol drug breaching patent rights, court told

A rival of pharmaceutical giant MSD is trying to sell a generic version of a cholesterol drug for less than one tenth of the price of its product in breach of patent rights, it has been claimed in court proceedings.

MSD Ireland's chief executive Ger Brennan says that if Clonmel Healthcare, of Waterford Road, Clonmel, Co Tipperary, is allowed to continue selling the drug, the loss of market share in Ireland and abroad "will be felt" by MSD's 150-strong workforce at its plant in Ballydine, Co Tipperary, close to Clonmel.

The Ballydine plant manufactures the active ingredient, Simvastatin, for the drug Inegy, which is used here by about 15,000 people a month to combat high levels of cholesterol in the blood. High cholesterol is the main cause of cardiovascular diseases, which are the main cause of death in the western world.

Some 50 per cent of Ballydine’s output constitutes Simvastatin and Inegy itself is worth about €8 million a year to MSD, Mr Brennan says.

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On Monday, Mr Justice Brian McGovern admitted MSD’s action against Clonmel Healthcare to the fast-track Commercial Court.

He also adjourned the hearing of an application to continue a temporary injunction, granted last week, preventing Clonmel marketing and distributing its version of Inegy, called Ezetimibe/Simvastin. Clonmel launched its product early last week.

MSD says Clonmel, part of the German publicly quoted group Stada, is infringing its patent rights, or supplementary protection certificate. In an affidavit, Mr Brennan said the entry of Clonmel into the Irish market with its generic version, offered "at a fraction of the existing price of Inegy" will result in a massive distortion to the market, which will cause irreparable and unquantifiable damage to MSD.

MSD is part of Merck, one of the top 10 largest pharmaceutical companies in the world. Mr Brennan said it had spent more than $7.3 billion (€5.97 billion) on research and development.

MSD’s exclusive rights in relation to products containing Ezetimibe in a combination with Simvastatin have been extended until April 2019, he said.

The “reimbursement price” – the price at which wholesalers sell to pharmacies – of Inegy is between €38.45 and €40.98, depending on strength, he told the court.

Clonmel’s “Ezetimibe/Simvastatin” product is sold at a net price of between €3.28 and €3.57.

If Clonmel is not restrained infringing MSD’s rights, four other generic companies which have already obtained authorisations to sell generic Inegy, will be “commercially compelled to enter the market”, Mr Brennan believed.

MSD is also engaged in litigation in several other European countries in relation to questions of law concerning its supplementary protection certificate patent rights. There is a real risk, if the Irish court does not restrain Clonmel, certain courts in other countries “may follow the same decision without due regard to the local circumstances”, he said.

Apart from its investment in research and development, which may be reduced as a result of the infringement of its rights, MSD also supports significant numbers of healthcare professionals to attend international medical congresses, enabling them to stay up to date on scientific developments and practice. These include GPs, pharmacists, consultant cardiologists, practice nurses and groups involved in diabetes care, Mr Brennan said.