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(1) Evalve Inc. (2) Abbot Cardiovascular Systems Inc. (3) Abbot Medical UK Limited v Edwards Lifesciences Limited, Patents Court, London, UK, 3rd May 2019, [2019] EWHC 1158 (Pat)

This judgment from Henry Carr J disposed of an interim injunction application by the Claimants (collectively “Abbot”) against the Defendant (“Edwards”). Abbot had alleged infringement of two of its patents, which cover a medical device used to treat mitral regurgitation (“MR”).

MR is a condition where the mitral valve does not close properly, allowing blood to flow backwards in the heart. Edwards is preparing to launch a device for treating MR which it calls the PASCAL. The PASCAL is implanted in the mitral valve via a catheter, by a procedure known as transcatheter mitral valve repair (TMVr). Abbot already sells a TMVr product (the “MitraClip”).

Prior to the hearing of the interim injunction application, Abbot had succeeded in getting an expedited trial listed with the result that a first instance decision is expected in January 2020. Accordingly, Henry Carr J had to decide, under the American Cyanamid guidelines, whether to grant interim relief covering Edwards’ activity between May 2019 and January 2020.

Edwards had accepted that there was a serious issue to be tried (the first stage of the American Cyanamid guidelines) and therefore Henry Carr J first had to consider whether Abbott had established that it would suffer irreparable harm if an injunction was not granted. Notably, Henry Carr J agreed with Edwards that if damages would be an adequate remedy for Abbott, then no injunction should be granted (and there would be no need to consider whether there would be irreparable harm to Edwards).

Since the National Health Service (“NHS”) does not yet fund the type of TMVr operation which can be effected by either PASCAL or MitraClip, the relevant market in the United Kingdom is currently very small (although the evidence suggested that funding will soon be available, and the market will therefore grow). There are currently only about 100 implantations of MitraClip per year in the UK and Edwards had undertaken that, before trial, it would limit implantations in the UK of its PASCAL device to 10 patients in two centres. There was also no evidence that Edwards’ activity would cause a downward spiral in price (indeed the PASCAL is likely to cost more than MitraClip). In addition, Edwards had accepted that for the purposes of any damages inquiry or other financial relief, each sale of PASCAL made by Edwards was a sale lost to Abbott.

Abbot’s evidence of irreparable harm centred on a possible detrimental effect on its reputation that would occur if Edwards were to launch now and subsequently be injuncted. In particular, Abbot argued that longstanding relationships it had with clinicians could be affected if Edwards launched now but was injuncted later. Henry Carr J was unconvinced by this argument, stating “If clinicians are upset by the grant of an injunction, this will happen in any event if Abbott are successful at trial”. Abbot further argued that it may be blamed for future retraining required in hospitals that had first used Edwards’ product and then found it withdrawn from sale. Henry Carr J found this allegation “fanciful”.

A further argument deployed by Abbot was that Edwards had known about Abbot’s patents and had failed to clear the way. Henry Carr J stated that this consideration would only be relevant if irreparable harm to both parties had been evenly balanced. It was not relevant to the question of whether there would be irreparable harm.

Henry Carr J ultimately held that there would be no irreparable harm to Abbott and therefore refused the injunction.

In case he was wrong about that, he then considered factors pointing to possible irreparable harm to Edwards if an injunction were to be granted. Edwards argued that, to fully benefit from the expected decision on NHS funding, it would be need to be in a position to launch fully later in 2019. If an interim injunction was granted now it would not be able to compete properly with Abbot and this could lead to an unquantifiable loss of sales. Henry Carr J accepted this argument and refused to grant the injunction having found that “even if Abbott will suffer some irreparable prejudice as a result of Edwards’ limited launch, then such prejudice is clearly outweighed by the irreparable harm that would be suffered by Edwards if the injunction is granted”.

A final point is worthy of note: in support of its argument for an interim injunction, “Abbott [had] characterised the PASCAL device as a copycat product, which was piggybacking on investment and training that had been carried out by Abbott”. Henry Carr J drily commented in his judgment that “this type of advocacy relied on too many animal analogies”. What’s more, Henry Carr J reminded Abbot that “to assert copying, it is a sign of weakness rather than strength” since it is irrelevant to a claim of patent infringement (it being an argument for infringement of an unregistered design right if any such right subsists).

A copy of the judgment can be found here.

Headnote by Nicholas Round, Bristows LLP