Drug firm’s injunction that would cost taxpayer €8m refused

The High Court has refused to grant an injunction that would have temporarily prevented the sale of a generic drug in the Republic and cost the Health Service Executive (HSE) about €8 million.

Biogen MA Inc and Biogen International GMBH wanted the orders to prevent the sale of a generic drug used to treat multiple sclerosis (MS) until the dispute about the validity of their patent has been determined at trial.

The injunction was sought against the generic drug’s owner and marketing company, Laboratorios Lesvi SL and Neuraxpharm Ireland Limited, which are part of the Neuraxpharm group. Biogen claims the Neuraxpharm parties are infringing its patent.

In a ruling, Mr Justice Michael Twomey noted that an order preventing the sale of the generic drug, called Tecfidera, would cost the taxpayer about €8 million in the 18-month period leading to the trial of the action.

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He said the HSE pays €1,030 per 240mg dose of Biogen’s Tecfidera, which has been prescribed in Ireland since 2015 under a scheme for the dispensing of high-tech drugs. The generic drug would cost the HSE €418 per 240mg.

The launch of the generic drug, Dimethyl Fumarate Neuraxpharma, was originally planned for August of this year, but this was halted by an interim injunction, granted on an ex-parte basis (only the plaintiff was represented) in July.

Neuraxpharm says preventing the launch of its generic drug will cost the taxpayer €5.5 million per annum. The judge noted Biogen’s drug Tecfidera had worldwide sales of $1.95 billion (€1.96 billion) in 2021.

Neuraxpharm claims the patent underlying Tecfidera is invalid on grounds that the parent patent was revoked in 2016 by a division of the European Patent Office (EPO) for various reasons, including that it did not involve an inventive step.

This was affirmed on appeal in 2022, which Mr Justice Twomey said “definitively” holds the parent patent as invalid.

The judge said Biogen has had an unlawful monopoly in Tecfidera for seven years, with the Irish taxpayer likely paying significant sums the firm was not entitled to.

The judge said there was clearly a fair issue to be tried regarding whether Neuraxpharm had infringed the divisional patent and if this patent was valid. He found that damages would be an adequate remedy if it transpired at the full hearing that the injunction was wrongly refused.

There were strong arguments for both granting and refusing the injunction, but the balance of justice favoured refusing it, he said.

The injustice against Biogen was lessened by the fact it had already had seven years of windfall revenue from its unlawful monopoly in Tecfidera, he went on.

Neuraxpharm had opposed the grant of the divisional patent which now protected Tecfidera at the European Patent Office, the judge noted, adding that the court could not make a finding that this patent was invalid. It could, however, reach a “tentative view” that Neuraxpharm’s case for invalidity was strong, he said.

The judge also found that the court could consider the public interest, in saving taxpayer money, as a factor in the balance of justice, in determining the dispute between two private parties.

He said that if he was wrong to refuse the injunction, the Irish taxpayer would have nonetheless saved about €8 million in the period between now and the full hearing.

Bearing in mind the injustice of the taxpayer having overpaid for a drug for seven years, it does not seem to the court that the injunction is an injustice to Biogen, which will be entitled to recover losses from Neuraxpharm if the divisional patent is deemed valid at the trial.

The balance of justice favoured refusing the interlocutory injunction and lifting the interim injunction that was imposed during the summer, he said.