Stay of injunction in public interest: Edwards Lifesciences v Boston

Edwards' crown jewels? The Sapien 3

In recent years, there have been several examples of patentees in the UK Courts opting not to enforce an injunction where the infringing product constitutes a potentially life-saving treatment. The case of Edwards Lifesciences LLC v Boston Scientific Scimed Inc & Ors [2018] EWHC 1256 (Pat) handed down yesterday, is a little more nuanced. It was common ground between the parties that an injunction should be stayed for a period and then qualified for a further period, but there was disagreement as to the length of that stay, and the scope and duration of the qualification.

Background

Back in 2015, Edwards Lifesciences issued a revocation action for Boston's EP (UK) 2 249 254 patent (the '254). Boston counterclaimed for infringement of the '254, and EP(UK) 2 926 766 patents, through dealings in a transcatheter heart valve (THV) called the Sapien 3 which had been launched by Edwards in Jan 2014.
Expert and factual evidence showed that  there are currently 7 THVs approved for use in the UK, and that the Sapien 3 represents about 60% of the market. For certain patient groups, the Sapien 3 is the only treatment option.  

The '254 was found invalid in the High Court [2017] EWHC 755 (Pat), but the '766 was held to be valid and infringed. Boston sought an injunction in the usual way, and Edwards resisted the grant of an injunction on the ground that there was a public interest in patients continuing to receive the Sapien 3.

The Court at first instance granted an unqualified injunction but stayed the injunction pending appeal (for which permission was granted on both sides). An order was also made for the provision of disclosure to assist Boston in making its election regarding an account of profits or a damages enquiry. On 10 May 2018, Boston elected for an account of profits, and those issues are likely to be heard in June to July 2019.

On 28 March 2018, the Court of Appeal dismissed both appeals, and remitted the issue of an injunction to the Patents Court - it is that hearing and issue which forms the basis of this post.  

Decision

Clinicians must be trained to use a THV, and it was common ground that a number of clinicians will need to be retrained to use another device in place of the Sapien 3.  Article 3 of the Enforcement Directive 2004/48/EC requires remedies to be "effective, proportionate and dissuasive", and the Court considered that proportionality is the key consideration in Article 3.  The Patents Court granted an initial stay of the injunction to permit continued implantation of the Sapien 3 for a 12 month period, to allow an appropriate period for clinicians to be retrained to use an alternative device, with permission to apply for an extension of the stay if longer is required for retraining. 

With regard to the small but growing number of patients for whom at present the Sapien 3 is the only suitable device, the Court allowed an exception to the injunction which is not limited in time.  It was common ground that the supply of the Sapien 3 valves to the patients in question should be permitted where there is an appropriate declaration from the responsible clinician.  The declaration should certify that in the clinician's judgment, the patient falls into one of the groups for whom there is no alternative to the Sapien 3.  Edwards is required to send clinicians an approved communication pursuant to Article 15 of the Enforcement Directive. 

Following on from the Warner-Lambert v Actavis [2015] EWHC 485 (Pat) (prescription by brand) Fujifilm v AbbVie [2017] EWHC 395 (Pat) (Arrow declaration) and Unwired Planet v Huawei [2017] EWHC 2988 (Pat) (global FRAND terms) decisions, this provides another example of the UK Patents Court providing highly specific and tailored relief appropriate to the facts of the case.