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| 2 minutes read

Neurim v Mylan put to bed (but Mylan dream of the EPO)

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:

"Of course, matters are not entirely in Mylan's hands but, on the very incomplete picture I have, I consider that Mylan will only engage in a downward price spiral if forced to do so by Teva. In that regard, Teva's deponents assure me that Teva have no intention or desire to engage in a price spiral, and that is a logical position to take in the current unusual circumstances. If no injunction is granted against Teva but Mylan lose their Appeal, Teva will then have a decision to make: do they continue selling or come off the market until after expiry? If they continue selling, they can engage in a duopoly with the Claimants until expiry and with that in prospect, it would not make sense to precipitate or engage in a downward price spiral in the month before Mylan's Appeal is heard. It may also make commercial sense for Teva to continue selling on the basis that most of the damage to the Claimants has already been caused and because in the last three months of the life of the patent the Claimants will not be able to raise their prices back to monopoly levels. By contrast, if Teva come off the market, they will have to re-launch on expiry along with all the other generics. On balance, the evidence points to Teva continuing on the market (unless restrained) with no wish to engage in a downward price spiral."

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.

Tags

litigation & disputes, epo patent oppositions, life sciences, patents