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We reported previously on the so-called injunction gap in German patent proceedings, and the steps that the English Courts can and do take to plug that gap - see England v Germany in patent race – who will be first? | Fieldfisher.
As a reminder, the injunction gap arises because in Germany, patent infringement issues are heard in a different court and to a different timetable to patent validity issues. Typically, to judgment on infringement takes about one year and to validity takes about two years. If infringement is found, often an injunction is ordered with little regard to validity, thus creating the injunction gap until the validity decision which, if the patent is held to be invalid, would terminate the injunction. This can, and does, give the patentee considerable leverage, particularly for patents with dubious validity.
If, however, the German infringement court considers that there are good grounds to conclude that the patent is invalid, then an injunction in the injunction gap period is much less likely to be granted. One factor which is persuasive, but not binding, is if a competent court in another country has already found the corresponding national European patent to be invalid. This often gives rise to a race to obtain a validity decision from the English Court, before a decision in Germany on the German infringement claim.
This trend continues as demonstrated in the recent case of Advanced Bionics AG & Advanced Bionics UK Limited v Med-El Elektromedizinische Gerate GmbH. In this case, having been sued in Germany for infringement of the German limb of the same patent, Advanced Bionics instigated an invalidity action in the English courts to invalidate Med-El's patent EP (UK) 3,138,605. Advanced Bionics then applied to the English court for the action to be expedited, citing the need to plug the injunction gap as the reason for expedition.
Following on from another recent case (Abbott Laboratories Limited v Dexcom Incorporated) and seemingly now becoming the central issue when deciding expedition to plug the injunction gap, the court had to consider:-
"the effects that an early injunction in Germany may have on the UK market to the disadvantage of a party who believes the EP is invalid and/or not infringed, and to decide whether those effects justify expedition of a trial in this country."
i.e. a determining factor is whether the effect of a German injunction on the UK market is slight, or whether there is a real risk that a party will suffer significant damage in the UK market as a consequence of the German injunction.
The product in issue in this case is Advanced Bionics' Hi Res 3D device (referred to in the Judgment as the '3D device'). It is a cochlea implant for those with poor or no hearing. As a device requiring surgery to implant in a patient and the need for connections to be made to an electrode located in the cochlea, it is fitted by audiologist surgeons, and is recommended to patients by such audiologists. The audiologists therefore are key in selecting which product to choose. Further, as parts of the device need replacing periodically throughout a patient's life, an audiologist will be reluctant to select a device in circumstances in which 'spares' may later no longer be available due to an injunction arising from a patent dispute.
The court stated:-
| "Even if I assume that no audiologists in the UK would become aware of the German infringement action, I find it very difficult to understand how UK audiologists would not hear very quickly that the 3D device was off the market in the major German market i.e. as soon as an injunction was granted in Germany. I am satisfied that word would go round the industry very quickly indeed. Many would then speculate whether the same was going to happen in the UK. This would lead both audiologists and patients to doubt whether it was advisable to have a 3D device implanted and to discussions to that effect on the blogs. In the unusual circumstances of this product market, I conclude that the grant of an injunction in Germany around the end of February 2022 (assuming Med-El’s infringement action succeeds) is highly likely to cause significant damage to AB and to the prospects of its 3D device recovering the market share AB had before the pandemic. Audiologists would be put off from recommending and patients would be put off from choosing implantation of the 3D device. For the reasons explained above, even the loss of a single patient results in very significant and long-lasting financial loss." |
The court concluded that an injunction in Germany could have a severe and potentially long-lasting detrimental impact in the UK, and for that reason ordered expedition of the English case in the expectation that if Advanced Bionics succeeded (i.e. the patent was held invalid) it would assist in plugging the injunction gap.
Comment
We have commented on the recent reforms to German patent law – see Changes to German patent law now on the horizon, but notwithstanding those reforms, the injunction gap can persist. English courts may therefore take steps to intervene if they consider there to be an unfairness created by the German injunction gap, and if that unfairness is likely to impact the UK market.