Patents Court finds medical device patent obvious over five items of prior art & CGK.
On 18 January 2021, Nicholas Caddick Q.C. sitting as Deputy High Court Judge, handed down his judgment in Coloplast A/S v Salts Healthcare Ltd. This judgment follows an eight day trial that took place in hybrid form over late September and the beginning of October 2020.
Coloplast alleged infringement of its patent EP (UK) 2 854 723. Salts denied infringement and counterclaimed for revocation on the bases of lack of novelty, lack of inventive step/obviousness, insufficiency, AgrEvo obviousness and added matter.
In parallel proceedings at the European Patent Office “EPO”, the Opposition Division “OD” had found earlier in October 2019 that the patent lacked novelty over one of the items of prior art relied on by Salts in the UK proceedings. This decision is under appeal to the EPO Technical Board of Appeal “TBA”, expected to be heard later in 2021. The EPO proceedings however are based on different claim sets, and so the Court accepted it needed to consider the case afresh.
In short, the Court found the patent invalid for lack of inventive step, but that had it been valid, it would have been infringed.
The case concerns ostomy bags, which are connected to a stoma created surgically, in order to collect human waste from the stoma, usually after surgery to address issues in the digestive tract. As with many medical device cases, the market for them is valuable, and this commercial significance sits alongside important issues around patient sensitivity.
The case involved many issues typical to patent litigation, and to that extent there was no “new” point of law at stake. What is unusual about the judgment though is that the patent was found invalid over all six cited items of prior art, being three prior publications and two prior uses, as well as the Common General Knowledge. AgrEvo obviousness was relied on also by Salts, but the judge found this added nothing more to the obviousness findings he had already made. This finding underlines the fact that although AgrEvo might be thought to be a sufficiency issue because it concerns lack of technical contribution, the UK courts tend to interpret it as an obviousness argument. As a matter of general interest, the UK approach to AgrEvo was summarised by Floyd LJ in Generics (UK) v Yeda Research & Development 2014 in the Court of Appeal but the judge did not deal with this in any detail, saying that it added nothing to his finding of conventional obviousness.
The case is also illustrative of the interplay between timings of parallel UK and EPO proceedings. Salts had earlier sought a stay of the UK proceedings pending the OD decision, which the Court had refused. But as things turned out, the OD did find the patent invalid and the appeal to the TBA will likely come on before any appeal to the UK Court of Appeal, should permission be granted.
From a procedural point of view, this was a substantive patent trial conducted in “hybrid” form, much of it online. Whilst not ideal, with for example some witness cross examination taking place by video link in a different time zone, it was a good example of how successfully the UK Courts have been able to adapt to the current circumstances induced by the COVID-19 pandemic.