The UK Court of Appeal has dismissed Mylan's appeal and thus Neurim's divisional patent has been held valid and infringed. While the details of the mechanics are not known, Mylan must surely now be injuncted (finally!) from sales of its melatonin product.
This decision follows those discussed in "Neurim again! Final Injunctions - to stay or not to stay, that was the question". It also follows an interim decision of 26 April in Neurim v Teva, which are separate proceedings on the same divisional patent. Mr Justice Mellor refused to issue a preliminary injunction against Teva in that application. Thus, as it stands, Teva are on the market. In refusing the preliminary injunction Mellor J discussed exactly this scenario (in the context of so called price spiral arguments), stating:
What all this seems to mean (but the Neurim saga keeps taking strange turns) is that Neurim have removed only one of two generic competitors from the market. Mylan will be able to recover their losses if they successfully fight it out at the EPO opposition proceedings (Neurim having given a cross undertaking to deal with this scenario). Meanwhile, the Teva proceedings are ongoing in the UK. It was made clear that "Teva have different validity attacks to those ruled upon by Marcus Smith in the Mylan actions, relying on different prior art" and so those remain hanging over Neurim. Much has been made of the failure of Mylan's expert to impress Marcus Smith J (e.g. see Arnold LJ at [7]) so a different UK decision in yet another round seems possible.
So, there is no end to the saga with this instalment. The divisional patent expires on 12 August 2022 but the fight will likely go on much longer.
Mylan appeal with permission granted by this Court on 16 March 2022. It is convenient to note before proceeding further that, since then, the Claimants have offered a cross-undertaking in damages in the event that Mylan's appeal is dismissed, but EP443 is subsequently revoked by the EPO. In the light of that offer, Mylan no longer pursues its application for a stay of the injunction granted by the judge pending the decision of the EPO (in practice, until expiry of EP443) if the appeal is dismissed.
