Bayer granted 10-day injunction in blood clot drug dispute
Judge disagrees that barrier against generic drug makers should be longer | Pharma company argues that ‘window should be shut’ on copycat versions due to potential for irreparable harm.
Bayer has failed to persuade the High Court of England and Wales to grant an interim injunction barring sales of a generic version of its blood clot treatment Xarelto (rivaroxaban) for longer than a period of up to ten days.
In a ruling handed down yesterday, March 27, His Honour Judge Richard Hacon, said that he disagreed with Bayer’s contention that the injunction against generic drug makers including Teva, Aspire Pharma and Stada should last longer.
Market monopoly
Up until now, Bayer has had the rivaroxaban market to itself.
However, its supplementary patent certificate—extending Bayer’s ownership of the compound rivaroxaban—expires on Monday, April 1.
This paves the way for generic drug makers to roll out generic versions of the drug.
However, these plans have been complicated by Bayer’s ownership of European patent EP 961, which has Swiss-form claims covering the use of rivaroxaban for the manufacture of tablets for once-daily oral administration to a human patient.
As this is due to expire in January 2026, Bayer has counter-claimed for infringement and sought an injunction against Teva and others to prevent them from releasing their versions of the drug.
Judge Hacon’s opinion this week follows a trial held in February, which was solely about the validity of EP 961 with regard to inventive step and other grounds.
The judgment from that trial is due to be handed down in the first week of next term, probably on April 9 2024.
‘Keeping the window shut’
There will, explained Judge Hacon, be a window of nine to 10 days after the compound patent expires before there is a possibility of a permanent injunction against the respondents restraining sales of once-daily rivaroxaban in the event that EP 961 is held valid.
“The purpose of Bayer's application is to keep the window shut,” he said.
Bayer argued the relevant period should be much longer than 10 days, submitting that there is sure to be an appeal whatever the outcome of the trial.
If the defendants succeed, Bayer says it will appeal and seek an interim injunction pending the outcome of their appeal.
Conversely, if it wins, Bayer argues that its opponents “will surely seek a stay of the injunction” pending the judgment on appeal.
But Judge Hacon disagreed on the basis that the issue between the parties concerned “the balance of irreparable harm”.
Long-term ‘harm’ unlikely
Bayer argued that the injunction should be longer because the entry of many suppliers of generics of rivaroxaban is bound to cause a price spiral downwards.
These long-term effects are likely to persist even Bayer regains its monopoly position and are difficult to assess, insisted the company.
Adding that the fall in price will happen within weeks or months of a generic launch, Bayer said that it may be forced to lower its own prices in order to maintain market share.
Further, it argued that its expected reduced market share would lead to the dismissal of staff, and the loss of established relationships and goodwill with partners in the field.
But Judge Hacon found that the short and crucial point about this application for interim relief is that it concerns only nine to ten days.
“I doubt that either Bayer or any of the respondents would suffer a great deal of irreparable harm on the alternative hypotheses of an injunction being granted or not,” he said.
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