THE ENGLISH COURT GRANTS CARVE-OUT PRELIMINARY INJUNCTION WHERE NO ALTERNATIVE TREATMENT AVAILABLE

Arnold J's judgment in Edwards Lifesciences LLC v Boston Scientific SCIMED, Inc and others [2018] EWHC 1256 (Pat) handed down on 24 May 2018 demonstrates the English Court's willingness to adopt a flexible and tailored approach to final relief by allowing both a stay and exception to a final injunction so that it accounted for the public interest in ensuring patients could continue to receive appropriate treatment.

At first instance ([2017] EWHC 755 (Pat)), Hacon HHJ granted an injunction but stayed it pending appeal. In doing so, Hacon HHJ indicated in his judgment that, in the absence of a stay pending appeal, he would have granted a "carve-out" injunction excluding from its scope a group of patients whose lives or health would potentially be put at risk by the injunction. Arnold J's judgment followed the Court of Appeal's decision ([2018] EWCA Civ 673) confirming that Edwards' transcatheter heart valve, Sapien 3, infringed a patent held by Boston.

Arnold J's starting point when considering the appropriate final injunction was that even on terms in which Boston receives a financial remedy for future sales of Sapien 3, any stay or qualification to a final injunction would deprive Boston of remedy to which it would ordinarily be entitled.  As a consequence, Arnold J highlighted that the length of any stay or qualification must be proportionate in balancing that interest (even though Boston was not exploiting its patent in the UK) against the public interest in ensuring that patients receive appropriate treatment.  Save for where it is aligned with public interest, Edward's interest was not a relevant consideration.

Arnold J considered the evidence before him from which he concluded that:

1. for a limited but growing group of patients the only available treatment required Sapien 3;
2. there was a large body of clinical opinion, but little hard data, suggesting that for a larger group of patients Sapien 3 was superior to the alternatives available on the market; and
3. the clinicians currently using the infringing device would need re-training if the injunction was granted.

In light of this, he granted an initial stay of the injunction for a 12 month period to allow enough time for all relevant clinicians to be retrained to use alternative devices, with permission to apply for an extension if required. With regard to those patients for whom no alternative to Sapien 3 was available, he granted an exception to the injunction requiring that the responsible clinicians for those patients provide declarations certifying that each patient falls within this exception. Although this exception was not time-limited, Arnold J gave Boston permission to apply to terminate the exception should alternative treatments become available.

Author