Neurim v Mylan: Take Two

Member News published by Marks & Clerk, under Healthcare Applications, Research (Technology)

Last we heard about the Neurim v Mylan battle, Mylan had the upper-hand. But the recent grant of a divisional patent to Neurim has, perhaps, turned the tables on Mylan.

Last time we were writing about the Neurim v Mylan battle concerning Circadin (“Going out with a Bang, what a difference 2 days makes”) it was Mylan with the upper hand ([2021] EWHC 530 (Pat)).  Neurim had been successful in the UK trial ([2020] EWHC 3270 (Pat)) but then lost that patent at the EPO by withdrawing their appeal (following negative indications at the oral proceedings).  Fast-forward to a busy last week of court term and Mr Justice Mellor (in a judgment dated 2 August 2021) has given Neurim a fighting chance of obtaining an injunction against Mylan by agreeing that Neurim can have an expedited preliminary issue trial ([2021] EWHC 2198 (Pat)).

This situation has arisen because a divisional patent (EP 3 103 443) granted on 30 June 2021 (but expires 12 August 2022).  Neurim promptly sued Mylan on the new divisional and are asserting that, because they were successful at the prior UK trial, Mylan are estopped from asserting invalidity or non-infringement. The normal course of UK litigation, while quick, would not provide Neurim with a judgment until after the patent has expired.  Further, an interim injunction is not a course realistically open to Neurim (this question between the parties has already been to the UK Court of Appeal: [2020] EWCA Civ 793)).

Mylan says the case is not so straightforward and has, in any event, applied to stay the action pending its opposition at the EPO (that application for a stay is to be heard in October 2021).

The issues ventilated at the hearing of the application are relatively complex (inevitably given the convoluted history of this dispute).  Mylan correctly argued that the circumstances do not present a set of preliminary issues which will necessarily be decisive because they are not purely questions of law.  However, ultimately, Mr Justice Mellor sided with Neurim and ruled “that it is just and right that Neurim should be afforded the opportunity to establish its patent right by way of a trial of preliminary issues – this being the only realistic way in which Neurim can hope to secure injunctive relief before expiry of EP443”

Further, expedition was permitted even though Mylan are unlikely to be able to use their chosen lead counsel and over the summer costs might be wasted by preparing for a trial which is ultimately stayed (if Mylan is successful on their application for a stay pending a decision by the EPO).

The October stay application will be the next instalment and after that a trial of preliminary issues is scheduled to be heard before the end of February 2022.  It will be interesting to see how Take Two progresses particularly as Mylan’s main defence is essentially about abuse of the patent system and so may be strategically instructive to patentees and challengers alike.


If you have any questions about this article or anything related IP litigation then contact Ian Turner.

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