The assumption in life sciences cases often is that a preliminary injunction pending trial will be granted if the alleged infringer intends to launch ‘at risk’ – i.e. without invalidating the patent first. In this case, however, the patent owner (Abbott), was denied an injunction because it was unable to demonstrate that failure to grant the injunction would result in it suffering irreparable harm.
Abbott owned two patents on its MitraClip device, which it alleged were infringed by Edwards’ competing Pascal device. These were medical devices to treat mitral regurgitation, a potentially serious heart condition in which the blood leaks backwards through the mitral valve; the device is implanted in the valve in a surgical procedure known as transcatheter mitral valve repair (TMVr). The UK market for such devices is currently small, because the NHS does not fund TMVr surgery, but this is expected to change in the near future. Pascal was already on the market in other countries where such surgery was funded, and Edwards now wished to carry out a controlled roll-out on ten patients in two UK hospitals in order to be ready to compete with MitraClip on the UK market when NHS funding became available. Abbott had previously obtained an order for an expedited trial, and, crucially, Edwards had agreed to limit its marketing activities until trial.
No irreparable harm
In order to obtain a preliminary injunction, the claimant must show that there is a serious issue to be tried (uncontentious in this case) and that the ‘balance of convenience’ favours an injunction. The judge, Henry Carr, held that Abbott failed at the first hurdle on balance of convenience because it was unable to show that it would suffer irreparable harm if no injunction was granted. Key factors here were that the controlled roll out proposed by Edwards was very limited and that Edwards had conceded that for the purposes of financial relief each sale of a Pascal device should be regarded as a sale lost to Abbott. This 1:1 approach made calculation of any damages due to Abbott very easy so that any loss would be easy to quantify. Pascal was also more expensive than MitraClip and there were no other competitors on the market, which meant that the introduction of Pascal could not trigger a downward price spiral as would usually be the case with the introduction of a cheaper generic.
Should Edwards have ‘cleared the way’?
Abbott argued that Edwards should have ‘cleared the way’ of (taken action to invalidate) conflicting patents before launching their device. In the case of the launch of a cheaper generic, failure to clear the way will usually be an important factor in favour of an injunction, because the launch is likely to trigger an irreversible downward price spiral. Carr J emphasised, however, that ‘clearing the way’ was an important factor where the parties were evenly balanced in terms of irreparable harm: it was not a factor here where Abbott had failed to demonstrate irreparable harm at all.
The case is a good reminder that the patent owner does not have a ‘right’ to a preliminary injunction in infringement cases. The court will always look carefully at the particular circumstances. In this case Edwards made some good strategic concessions by agreeing to limit its marketing during the initial controlled roll-out, allowing it to be ready to launch fully at the right moment if it is successful in seeing off the allegation of patent infringement at trial.
The case: Evalve Inc., Abbott Cardiovascular Systems Inc., Abbott Medical UK Limited v Edwards Lifesciences Limited 3 May 2019  EWHC 1158 (Pat)