Novartis settles one of two MS drug patent disputes

Action against generics group Mylan continues after terms agreed with rival generics player Accord Healthcare in patent infringement case

Swiss drug firm Novartis has settled one of two Dublin High Court cases against generic medicine companies relating to its multiple sclerosis drug, Gilenya
Swiss drug firm Novartis has settled one of two Dublin High Court cases against generic medicine companies relating to its multiple sclerosis drug, Gilenya

Pharmaceutical company Novartis has settled High Court proceedings against a rival firm alleging infringement of its patent on a drug for treating multiple sclerosis (MS).

Switzerland-based Novartis AG and its Irish affiliate, Novartis Ireland Ltd, said their medicine to treat relapsing-remitting MS, Gilenya, is “one of the most important and valuable products” in its portfolio, contributing more than $2.7 billion (€2.56 billion) of net sales in 2021.

The Novartis group, which has offices in Dublin and Cork, claimed Spain-based Accord Healthcare SLU and its Irish entity, Accord Healthcare Ltd, breached its patent on Gilenya. Accord denied the claim.

Lawyers for Novartis on Friday told the High Court the case had been settled and could be struck out. Mr Justice Denis McDonald congratulated the parties on reaching a consensus and struck out the case.

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A similar action brought against another generic drug maker, Mylan, which is part of the Viatris group, was unaffected by the agreement and would continue, barrister Paul Coughlan, for Novartis, said.

Gilenya contains the active ingredient fingolimod. Accord markets its version of the medicine under the name Fingolimod Accord, while the Mylan version is called Fingolimod Mylan.

Novartis’s case remains against Mylan Healthcare Ltd, Mylan Healthcare Ireland Ltd and McDermott Laboratories, trading as Gerard Laboratories, which itself trades as Mylan Dublin and markets the product in Ireland. The companies reject the allegations.

Ellen O'Riordan

Ellen O'Riordan

Ellen O'Riordan is High Court Reporter with The Irish Times