German injunction gap helps to expedite Advanced Bionics preliminary issue in hearing loss dispute

Unlike, the Patents Court
the AmeriKat is not expediting 
anything, even for a German
injunction gap...

If you see some tired patent litigators in the UK, it might be because there are an alarming number of applications for expedition of trials and issues, with a significant number being granted.  After Neurim v Mylan [2021] EWHC 2198 (Pat) and Abbott v Dexcom [2021] EWHC 2246 (Pat) (see IPKat article here), Mr Justice Mellor handed his third judgment in a month regarding expedition in
Article on Advanced Bionics v Med-El [2021] EWHC 2415 (Pat).  Similar to Abbott v Dexcom, the key reason for the present application was to avoid the German injunction gap (an issue explained in detail in Abbott v Dexcom, [33]). Unlike Abbott v Dexcom, Mellor J granted expedition for this case, as IPKat friend friend, Brussels-based trainee patent attorney, Henry Yang explains. 

Over to Henry:

"Med-El had a patent EP (UK) 3 138 605 B related to cochlear implants which enable individuals with permanent hearing loss to perceive sound ([27]). In the UK Advanced Bionics sought to invalidate the patent and/or to establish that their product ‘3D device’ did not infringe ([1]). In Germany Med-El had already initiated an infringement action in Mannheim court which was to hand down its judgment by the end of February 2022 ([16]). Since a German nullity action cannot start before the end of the opposition before the European Patent Office (including its appeal), the current timeframe before the EPO meant the injunction gap would last at least from the end of February 2022 to June 2022 ([18]).

Judgment

The Judge had already stated the principles of expedition in Abbott v Dexcom whose paras [6] – [9] were referred to ([5]). The key authority remained Gore v Geox [2008] EWCA Civ 622. For convenience the Gore factors are copied below:

‘(1) whether the applicants have shown good reason for expedition;

(2) whether expedition would interfere with the good administration of justice;

(3) whether expedition would cause prejudice to the party; and

(4) whether there are any other special factors.’

The Judge also cited [6] of Teva v Janssen [2021] EWHC 1922 (Pat) which stated that all the matters related to the Gore factors are to be assessed on a sliding scale, for example how good the reason for expedition is and the degree of acceleration ([6] of the present judgment).

On the first Gore factor ‘whether the applicants have shown good reason for expedition’, the Judge considered the key argument of Advanced Bionics as avoiding severe irreparable damage in the UK market caused by the UK market learning that a German court has injuncted Advanced Bionics’s 3D device and thus steering clear of that device ([50]). To evaluate this argument the Judge first assessed the current state of the UK market. Before the COVID pandemic Advanced Bionics had about 20% of the market and Med-El 5% ([44]). There have been two changes since. The first was that the COVID pandemic created delays in implantation. A surge of 70% in market demand was predicted in the coming 18 months. Advanced Bionics regarded this as an inflexion point which could reconfigure the market share distribution ([48]). The second was a voluntary product recall of Advanced Bionics’s first version of the 3D device. This appeared to be one of the reasons why Advanced Bionics’s market share further dropped to around 11%. The Judge considered this further drop made Advanced Bionics particularly vulnerable at the inflexion point if they were not able to compete at that moment ([49]).

On the market position in the UK, Med-El made three points ([59]): Advanced Bionics had not shown any need for commercial certainty in the short term; it is unlikely that the patients and clinicians would know the proceedings in Germany; and apprehension about the detriment of a German injunction on the UK market was not justifiable. The Judge dismissed the first point as a repetition of the argument that Advanced Bionics had failed to clear the way ([59]; see below on the argument on clearing the way in [55]). The second point was rebutted by evidence which included an example that a clinician was aware of a potential patent dispute ([62]). The Judge considered it likely that a UK audiologist would learn quickly that the 3D device was injuncted in the German market ([64]), thus dismissing the third point. Consequently the Judge held that an injunction in Germany would cause significant damage to the UK market. Besides, a subsequent UK trial judgment in favour of Advanced Bionics would not remedy the situation immediately once there are doubts whether to implant the 3D device ([66]).

Med-El submitted several additional arguments (which appeared to relate to the first Gore factor), but the Judge did not find them to be persuasive ([53] – [58]): first, the Judge was curious why the patentee Med-El had not supported the application for expedition since they had an interest in establishing infringement as soon as possible thereby removing the 3D device from the market ([54]). Secondly, although Med-El submitted that Advanced Bionics could have cleared the way by bringing a UK revocation action ever since the patent was granted in April 2019 ([55]), the Judge agreed with Nicoventures v Philip Morris [2020] EWHC 1594 (Pat) which distinguished the difference between the risk presented to an international group by a rival who had patents and the risk when that rival actually initiated infringement proceedings ([56]). Here, the risk increased when Med-El initiated the proceedings in Germany. Also, the advantages of bringing a centralised opposition before the European Patent Office instead of national tribunals were obvious ([57]). The third and fourth points related to how the Mannheim court would react to the English court’s judgment, but the Judge regarded them to be matters of the Mannheim court ([58]).

As a result the Judge held the first Gore factor in favour of Advanced Bionics ([67]).

The Judge then went on to consider briefly the other Gore factors. Listing the trial in February 2022 would not displace any other litigant ([69]), thus expedition would not interfere with the good administration of justice. An early trial in February 2022 would not cause prejudice to the party as Med-El was familiar with the 3D device, the patent, and the only piece of prior art cited against it. Finding an expert before this date was not thought to be difficult either ([70]). Although Advanced Bionics tried to indicate the unique benefits offered by the 3D device, the Judge declined detailed discussion of any special factor, save mentioning that clinicians had their respective preferences of difference devices ([71]).

Conclusion

Advanced Bionics’s application for expedition succeeded. The trial is to be listed in February 2022, in March 2022 if this turns out to be difficult.

Comments

The Gore factors involve essentially a multi-factorial test heavily dependent on the facts of each case. For this case in particular, just as in [45] of Neurim v Mylan where the Judge approved expedition based on ‘the unusual circumstances of this case’, in the present judgment the Judge explicitly mentioned in [64] that his conclusion that a German injunction would cause significant damage to Advanced Bionics was based on ‘the unusual circumstances of this product market’. As such this judgment is likely to have limited application for future disputes."