The issue of whether public interest considerations can be relied upon against the grant of a final injunction, or for a carve out in the injunction, is a very live one in disputes in relation to innovative medical devices and pharmaceuticals. In this decision, Edwards argued that, although its PASCAL product used to treat mitral valve regurgitation (a heart defect) had been found to infringe Evalve / Abbott’s patents, an injunction should not be granted because that would not be in the public interest. Mr Justice Birss rejected this argument and granted a final injunction with a limited carve out, which was not resisted by Abbott, for instances where implantation of Abbott’s MitraClip product had proved unsuccessful. Birss J held that the power to refuse or qualify a patent injunction on public interest grounds was limited and should be used sparingly.
Mitral valve regurgitation is a heart defect which leads to a leakage of blood from one ventricle to another. MitraClip and PASCAL are devices which aim to reduce such leakage by clipping the two leaflets of the valve together – “eeTVR” is an acronym for “edge to edge transcatheter valve repair”. The judgment on the public interest issue was handed down alongside the main patent trial after a 5 day trial specifically on the public interest issue. In the patent trial, Birss J determined that the PASCAL device of Edwards infringes two of Abbott’s patents which protect the MitraClip device. Both such devices are used in the transcatheter technique to treat mitral valve regurgitation, the only effective alternative to which had, prior to MitraClip, been open heart surgery. Such surgery is not suitable for a significant number of elderly patients suffering with the illness.
Edwards’ case was that there exists a body of doctors in the UK in whose reasonable opinion PASCAL would, in some instances, be a more suitable device than the MitraClip. Therefore, it was not, Edwards argued, in the public interest to prevent such doctors from using PASCAL. Edwards therefore asked the court to refuse an injunction altogether.1 Edwards further submitted that should an injunction be granted, there should be a carve out for instances where the MitraClip had proved unsuccessful. With the exception of agreeing such a carve out, Abbott submitted that, on the evidence, all patients who could be treated by eeTVR (and it admitted some could not) could be treated using MitraClip on an objective basis and in the reasonable opinion of doctors today. Furthermore that the fact that some doctors would prefer using PASCAL does not justify refusal of an injunction and that Edwards had not established that there was any class of patient for whom PASCAL is the only viable treatment or a better treatment than MitraClip.
Following an analysis of domestic and European law on the public interest relating to patents, Birss J detailed seven principles which can be summarised as follows:
- A general injunction to restrain future infringements is the normal remedy for the patentee.
- The burden is on the defendant to give reasons why such an injunction should not be granted2.
- All the circumstances should be considered. The public interest is a relevant consideration.
- The public interest may justify refusal of or carve out from an injunction, and an award of damages in lieu. The extent of or difficulty in calculating the damages in lieu is not determinative.
- The starting point of public interest considerations in relation to patent infringement remedies is that the patent system as a whole is already criss-crossed with provisions which strike balances between different public interests.
- Injunctions are important features of the patent system; the monopoly granted by an injunction is something which it is in the public interest to protect.
- Parliament is better equipped than the courts to determine public interest issues; the power to refuse or qualify a patent injunction should be used sparingly and in limited circumstances.
Damages in lieu of an injunction and compulsory licences
On the issue of whether damages were an adequate remedy in lieu of an injunction, Birss J noted that the proper compensation in this case where the patentee was selling its own product would be the patentee’s lost profits. Payment of a reasonable royalty in lieu of an injunction instead of lost profit damages which was the alternative remedy that would keep PASCAL on the market, would leave the patentee substantially out of pocket. Birss J noted that these considerations illustrated why what Edwards was seeking ought properly to be regarded as a compulsory royalty bearing licence. He drew attention to the compulsory licence provisions and noted that that the public interest test which would justify refusal or a carve out that he had laid out was not far from the test for a compulsory licence. In the circumstances of this case, where market demand was met by the patentee’s product, no compulsory licence would have been available either. For one of the patents, the 3 year post grant period in which a compulsory licence application cannot be made, had not expired. However Birss J stated that the public interest that would justify a carve out from an injunction would justify a carve out pending a compulsory licence application. These observations suggested that Birss J was encouraging the statutory provided route for avoiding an injunction.
Practically, Birss J noted that if a potential infringer is contending that no injunction should be granted at all, then the court must have evidence which is relevant to the assessment of whether damages are an adequate remedy at the trial at which the court is determining whether or not to grant the injunction. It was a mistake therefore to assume that such evidence was only needed in the inquiry as to damages trial which would usually follow the court’s decision to refuse or qualify an injunction. This has the practical effect of frontloading the financial evidence which typically in patent cases would follow the substantive determination on infringement and the subsequent form of relief hearing.
Application of legal principles to clinical setting
Birss J found that a reasonable doctor’s decision to choose PASCAL over MitraClip was not, by itself, sufficient to invoke the public interest as a ground for refusing or qualifying an injunction. What is required is sufficient objective evidence of patients who ought not, in the reasonable opinion of a body of doctors, to be treated using the patentee’s product and who could be treated with the infringing product instead. Birss J stated that the relevant public interest sufficient to justify a refusal of a patent injunction is the need to protect the lives of patients or to protect against serious risks to health where the infringing product is the only suitable treatment, provided that is established by objective evidence. The public interest in freedom of doctors exercising clinical judgement should be balanced against the patentee’s right to an exclusionary monopoly and, in the opinion of Birss J, such a balance should be struck by Parliament, not the judiciary. Birss J felt that the restriction of the choice open to doctors that the patent system can cause is in the public interest overall because it promotes innovation.
Birss J further found that to refuse an injunction on public interest grounds would inevitably lead to patients being treated with PASCAL where MitraClip, objectively, is a perfectly adequate treatment. This would, he stated, undermine the patent system. Edwards advanced a fall back list of criteria which defined patients for whom PASCAL was objectively the only suitable treatment, but the evidence available had not established the same.
Overall, Birss J’s decision to grant the injunction appears to be based primarily on the fact that the patentee’s competing product could ‘do the job’ of the infringing product, even though there were clinical preferences as between doctors, and that, in such circumstances, any remedy other than an injunction would firstly penalise the patentee but also interfere with Parliament’s responsibility in balancing the competing public interests in the protection of innovation and in the clinical freedom of choice, through the statutory provisions. The case therefore sets a high bar for the clinical evidence that a potential infringer resisting an injunction must obtain in support of the superiority of its product as compared to a patentee’s own product and frontloads the financial evidence in order to support the claim that damages are an adequate remedy where the patentee sells its own product.
This article was co-authored by Rafi Allos
1In this regard the current case can be distinguished from the previous case of Edwards v Boston, where the parties had already agreed that a final injunction should be granted but subject to a carve out and the dispute was regarding the scope of the carve out.
2The burden on the party seeking to show an injunction would be disproportionate is a heavy one, following HTC v Nokia.