Pharma giant claims jobs at risk as court hears rival attempting to sell much cheaper generic version of drug
A rival of pharmaceutical giant Merck Sharp and Dohme (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 Gerard Brennan says if Clonmel Healthcare, 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, Clonmel.
The Ballydine plant manufactures the "Simvastatin" active ingredient for the drug "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.
Some 50 per cent of Ballydine's output constitutes Simvastatin and Inergy itself is worth around €8m a year to MCD, Mr Brennan says.
Yesterday, Mr Justice Brian McGovern admitted MSD Incorporated'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 from marketing and distributing its version of Inergy, called Ezetimibe/Simvastin.
Clonmel launched its product early last week.
MSD says Clonmel, part of Stada AG publicly quoted group based in Germany, is infringing its patent rights, or supplementary protection certificate (SPC).
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, one of the top 10 largest pharmaceutical companies in the world, has expended more than US$7.3 billion on research and development, he said.
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 Inergy is between €38.45 and €40.98, depending on strength, he said.
Clonmel's "Ezetimibe/Simvastatin" product is sold at a net price of between €3.28 and €3.57.
If Clonmel is not restrained from 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 believes.
MSD is also engaged in litigation in several other European countries in relation to questions of law concerning its SPC patent rights.
There is a real risk if the Irish court does not restrain Clonmel, certain courts in these 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 health care 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.
