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Abbott v Edwards Lifesciences – Getting to the Heart of Interim Injunctions in Patent Litigation

By Brian Whitehead, Consultant

The judgment of Henry Carr J in Abbott v Edwards Lifesciences, whilst breaking no new ground in legal terms, provides a useful illustration of the English courts’ approach to applications for interim injunctions in patent cases.

The dispute concerns medical devices for treating mitral regurgitation, which “is a life-threatening condition in which the mitral valve of the heart ceases to function properly”. The patentee, Abbott, markets a product called MitraClip, which is implanted into the mitral valve. Although the UK market for the device is currently very small, because the implant procedure is not presently funded by the NHS, the NHS is currently considering whether to fund the procedure, in which case of course the market will expand. Edwards has developed its own device, which it intends to launch under the name PASCAL. Edwards’ intention is to roll out PASCAL in a small number of hospitals between October 2019 and February 2020, with a controlled roll-out to continue thereafter until the end of June 2020. Abbott has commenced patent infringement proceedings, and applied for an interim injunction against Edwards.

Interim injunction applications are governed by the so-called American Cyanamid principles, as follows:

  • The court does not generally carry out a detailed analysis of the merits of the underlying case. Provided the court is satisfied that there is a serious issue to be tried, the court proceeds to the next step.
  • The court asks whether there is a likelihood that the claimant, if denied an interim injunction, will suffer irreparable or unquantifiable harm i.e. harm that cannot be compensated in damages.
  • The court then asks whether, in the event that an interim injunction is granted and the claimant subsequently fails at trial, the defendant is likely to suffer irreparable or unquantifiable harm i.e. harm that cannot be compensated under the cross-undertaking in damages which the claimant is required to provide.
  • If there is a likelihood of irreparable or unquantifiable harm to both parties, the court carries out a balancing exercise, determining which course of action (granting or withholding the interim injunction) seems likely to cause the least irremediable prejudice to one party or the other.
  • In carrying out that balancing exercise, the court can take into account factors other than irreparable harm. Preservation of the status quo can be an important factor, as can be (in appropriate cases) public interest. Less commonly, the court may take into account the apparent strength of the parties’ cases, although that is a more exceptional factor.

It was common ground between the parties that there was a serious issue to be tried, and the judge was not therefore required to look at the merits of the claim (or the counterclaim for revocation). In addressing the issue of likelihood to irreparable harm to Abbott, a matter of key relevance was the fact that Abbott had already obtained an order for an expedited trial. Clearly, the shorter the period between an interim injunction hearing and trial, the lower is the likelihood of irreparable harm occurring. Specifically, the claim was commenced at the end of January 2019, and the trial will take place in December 2019, with judgment expected by the end of January 2020. The injunction hearing took place at the beginning of May 2019, and consequently the court had to consider whether there was a likelihood of irreparable harm in the approximately nine month period until judgment. The nature of the activities proposed by Edwards in that nine month was also of key relevance. As the judge put it, “A full-scale launch pending trial would raise different considerations from a controlled testing of the market”. Edwards gave an undertaking that it would do no more than implant PASCAL devices in 10 patients in 2 UK hospitals. Given that limited activity, the judge held that damages could easily be quantified following trial, on a one-for-one lost sale basis.

The claimant marshalled a number of alternative arguments in support of its irreparable harm argument, including the risk of cross-selling, risk of disrupting Abbott’s relationships with clinicians and the risk of brand damage to Abbott. The judge rejected each of those arguments. Of particular interest is the judge’s rejection of Abbott’s argument based on Edwards’ failure to clear the way of patents before deciding to launch PASCAL. There is a long-standing principle in English patent law that it is desirable for a party, seeking to launch a product, to identify and “clear the way” (whether by a revocation action or by an application for a declaration of non-infringement) of potentially relevant third party patents. A failure to clear the way has been held to be a factor in favour of an interim injunction being granted. The judge examined the rationale of that principle, holding that “failure to clear the way is a material factor in cases where irreparable harm to both parties is evenly balanced”. Where, as in this instance, no likelihood of irreparable harm to the claimant can be demonstrated, a failure to clear the way is simply an irrelevant factor.

Given the judge’s findings as to lack of irreparable harm to Abbott, it was not strictly necessary for him to consider the next American Cyanamid question – likelihood of irreparable harm to Edwards. However, the judge did consider that question, in case he was held on appeal to be wrong in relation to the first question. The judge held that if Edwards was injuncted, it would be unable to compete with Abbott when (as the parties expect) the NHS agrees to fund the implantation of mitral valve implants. The effect of that inability, at the outset of an expanding market, would be difficult to quantify in financial terms. Consequently, the judge held that even if (contrary to his primary finding) Abbott does suffer some irreparable harm, that is clearly outweighed by the irreparable harm to Edwards.

The final point of interest is in relation to costs. The parties had incurred substantial costs in preparing evidence as to whether PASCAL is clinically superior to MitraClip. Such evidence would have been relevant had the balance of irreparable harm been even, in which case public interest issues – i.e. the desirability of an allegedly superior product being available – may have been decisive. In the event, given his findings as to likelihood of irreparable harm, the judge did not take the evidence as to clinical superiority into account at all. He ruled whereas Edwards should recover its costs of the application, there should be a deduction for in respect of its costs of the public interest issue. He further cautioned “In my view, parties should think very carefully before setting this ball rolling on an interim application, and I have been told that in this case, the combined costs of this evidence alone, concerning clinical superiority, are in six figures”. In our view, it is difficult to criticise Edwards’ decision to marshal such evidence. It is not easy to predict the judge’s findings as to likelihood of irreparable harm, and a prudent defendant will wish to have a “back up plan”, in case the balance of irreparable harm is held to be even. There is an inevitable risk, though, that the cost of preparing evidence for such a fallback argument may end up being irrecoverable if the primary argument is successful.