Having already fought it out in Delaware, London and Washington, a battle between two of the world’s biggest medical device companies is coming to Dublin. 

Court filings show Abbott Laboratories filed proceedings against Edwards Lifesciences with the High Court. 

The companies have been fighting over a new type of medical device: a tiny, delicately engineered clamp, made out of wire mesh, which is fixed to a valve inside the heart. 

The clamp’s job is to fix something called mitral valve regurgitation. That’s a condition where the heart valve doesn’t close tightly, allowing blood to flow backwards into the heart. It can cause dizziness and lightness of breath and, in extreme cases, heart failure. 

The companies have been in court recently because Abbott is trying to keep Edwards’ out of the mitral valve regurgitation market. Abbott released its mitral clamp product in 2013, which it calls the MitraClip. Edwards’ version of the mitral clamp is called Pascal. It’s expected to hit the market this year. 

From the MitraClip patent document

The MitraClip has been credited as a huge sales driver for Abbott: “Abbott Going Gangbusters on MitraClip Sales”, said the Medical Device and Diagnostic Industry in 2016.

According to Vantage, a consultancy, the MitraClip is expected to do $933 million in sales in 2020. The Pascal, by comparison, is expected to do $74 million. 

Last June, Abbott went to the High Court in London seeking an injunction that would block Edwards from launching the Pascal in the UK. Abbott argued that its reputation would be harmed if the Pascal were allowed to be launched and then subsequently injuncted; also that Abbott would be blamed by hospitals if Pascal was withdrawn and they were forced to pay for retraining. The judge didn’t buy it. 

Just last week, Edwards had an appeal denied by the Patent Trial and Appeal Board in the US. Edwards had tried to challenge some of the patents originally awarded to the MitraClip back in 2009. It claimed the Abbott had simply made obvious changes to preexisting technology. Again, the US judge didn’t buy it. 

Abbott Laboratories and Edwards Lifesciences are big investors in Ireland. Abbott in particular has been in the country since 1946. It employs nearly 3000 people at nine sites across the country. Edwards’ operation is small but growing. It employs 50 in Shannon and last year, it announced a €160 million investment in Limerick, which will create 600 jobs. 

Both companies are enormous by any standards. Abbott is worth €142 billion, Edwards €42 billion. By comparison the largest Irish company, CRH, is worth €20 billion. 

The procedure where a MitraClip or Pascal is fitted is called a transcatheter mitral valve repair (TMVr). TVMr surgery isn’t yet available in the Irish public system, only in private clinics. The situation was the same in the UK last year when Abbott took its high court case against Edwards; however it was expected the public system would begin to fund TMVr surgery “in the near future”, according to Stevens & Bolton, a law firm. In Ireland, as in the UK, Abbott is looking to get in early. 

Abbott is being represented in the case by A&L Goodbody.