Court refuses injunctions in pharma patent case

A judge has refused to grant injunctions restraining a Co Galway-based pharmaceutical company from acting in alleged infringement of patent by making a generic drug here for supply to multiple sclerosis patients in the US.

Israeli-incorporated Teva Pharmaceutical Industries Ltd sought the orders pending the outcome of its proceedings initiated in the Commercial Court last year against Mylan Teoranta, trading as Mylan Institutional, which employs more than 1,000 people in Dublin, Meath and Galway.

Yeda Research and Development Company Ltd, also incorporated in Israel, is registered owner of the patent at issue and has granted an exclusive licence in respect of it to Teva. Yeda was joined as a co-defendant to the case to address a technical objection made by Mylan.

Teva alleges a drug being manufactured by Mylan at its plant in Inverin, Co Galway, for supply to MS patients in the US infringes a patent of which Teva is exclusive licensee.

Mylan denies the claims.

Mr Justice David Barniville noted Copaxone is Teva's drug for the treatment of relapsing forms of MS.

Teva Pharmaceuticals US, a subsidiary and licensee of Teva, is an authorised distributor of Copaxone and others medicines in the US on Teva’s behalf.

The drug at issue in this case is Mylan’s generic glatiramer acetate 40mg/ml drug, referred to as Mylan’s 40 mg GA product, he said.

Manufactured in Galway, it was launched by Mylan in the US last October to compete with Copaxone 40mg, Teva’s 40mg GA product.

The Mylan drug, the judge noted, does not have a marketing authorisation here and is not sold here. It is exported to the US where it is supplied and prescribed to MS patients.

New dosing regime

The US Food and Drug Administration had in 2014 approved a new dosing regime for Copaxone and granted Teva a three-year period of marketing exclusivity which expired in January 2017. The global revenues for Copaxone are “very significant”, amounting to almost $2 billion (€1.7 billion) in the first two quarters of 2017, he noted.

Mylan had in 2009 sought approval from the FDA for a high-quality generic Copaxone equivalent.

When the three-year period of exclusivity for Copaxone ended in late January 2017, the FDA grated approval for Mylan’s 40MG GA drug.

Having analysed the law and evidence, the judge said he was satisfied Teva had raised a substantive issue to be tried concerning its claims of patent infringement.

However, he was also satisfied, if Teva ultimately won its action, damages would be an adequate remedy for it.

Given those findings, it was not necessary for him to decide where the balance of convenience lay but, if he had to decide that issue, he would have concluded the balance of convenience clearly favoured refusing injunctions.

This was for reasons including, by the time the injunction application was heard, the Mylan product was on the US market for several months. Also, there was no prohibition on other generics entering the US market to compete with Copaxone, subject to FDA approval and five other generics have sought such approval, he said.