The Patents Court has rejected an application for an interim injunction in a medical devices case (Abbott v Edwards). Whilst the facts of the case are perhaps unusual, the decision is a reminder that where a patent owner cannot establish that it will suffer irreparable and unquantifiable harm, it will not be possible to obtain an interim injunction. Further, whilst in a number of previous interim injunction cases in the pharma field, the Courts have taken into account the fact that a generic competitor has not taken steps to clear the way to market, these arguments will only become relevant where the Court establishes that irreparable harm to both parties is evenly balanced.
Abbott alleges infringement of two patents relating to its Mitraclip product, a medical device for treating mitral regurgitation, a life-threatening condition in which the mitral valve of the heart ceases to function properly. Such devices are implanted through a procedure known as transcatheter mitral valve repair (TMVr). Mitraclip, recognised as a life-saving product, is commercially important for Abbott, with significant worldwide sales. However, only a small proportion of those sales are currently in the UK, as TMVr products are not currently funded by the NHS.
The claim relates to Edwards' TMVr device, PASCAL, which it intends to roll-out in a controlled manner in the UK from October 2019. NHS England is considering funding for a certain type of TMVr products, with a favourable decision anticipated in due course, which may be met by either Edwards' or Abbott's device.
Following Abbott's application for an expedited trial, the trial on infringement and validity will take place in December 2019. Despite this, Abbott sought an interim injunction arguing that it would suffer irreparable or unquantifiable loss as a result of the limited roll-out intended by Edwards.
No interim injunction
When assessing whether to grant an interim injunction, the Court applies the test set out in the American Cyanamid decision. Importantly, the Court must consider each of the steps in the test in a sequential way. For example, if the Claimant is unable to show (under the second step in American Cyanamid) that it will suffer irreparable harm or unquantifiable harm (i.e. the Court considers damages would be an adequate remedy for the Claimant), there is no need to proceed further with the assessment. As a result, the Court will not go on to consider whether the Respondent would suffer irreparable harm as a result of an interim injunction but will refuse to grant the interim injunction.
Here, Edwards indicated it would offer an undertaking pending judgment/order to arrange implantation of PASCAL devices in only 10 patients in two UK hospitals. It also accepted that each sale it made amounted to one lost sale to Abbott. Further, the facts of the case were clearly different to the perhaps more typical case relating to pharmaceutical products, where there are a number of generic competitors, with the patentee able to make arguments of an alleged downward price spiral. Accordingly, the Court found it easy to conclude that any harm caused to Abbott was quantifiable, also rejecting Abbott's arguments of potential reputational damage.
The Court also rejected Abbott's reliance on Edwards not having made any attempt to clear the way before bringing its PASCAL device to the UK market. This can often be a significant factor in innovator/generic litigation, but the Court stressed that it will only be a relevant factor where the irreparable harm to both parties is evenly balanced, at which point additional factors (in addition to clearing the way, maintaining the status quo) become relevant. As the Judge had concluded that Abbott would not suffer irreparable harm, Edwards' failure to clear the way was not a relevant consideration. If the irreparable harm assessment had been evenly balanced, Edwards argued that the Court would also need to consider public interest issues (concerning PASCAL's alleged clinical superiority). The Judge did not consider this argument, but did note that this evidence had caused the costs in the case to 'spiral out of control', going on to make a substantial reduction in Edwards' recoverable costs.
Finally, the Judge criticised Abbott for alleging that PASCAL is a copycat product, in light of the UK courts consistently stating that allegations of copying are irrelevant to patent infringement. Indeed, said the Judge, asserting copying in a patent infringement case (as opposed to a design case) "is a sign of weakness rather than strength."