EP 3 725 778 B1 relates to solid formulations of enzalutamide. More particularly, this disclosure relates to pharmaceutical compositions comprising a solid dispersion containing enzalutamide and at least one polymer.
EP 3 725 778 B1 is a divisional application of EP 2 895 463 A1, originally published under WO 2014/043208. The parent application is deemed withdrawn.
Brief outline of the case
The ESR only mentioned four documents of category A.
Eleven oppositions were filed against the patent.
The patent was maintained by the OD according to a MR.
Opponents 1-6, 9, and 11 lodged appeals against the maintenance of the patent. One of the appellants/opposants is the Dutch company Synthon (O6).
The board confirmed the maintenance as decided by the OD.
A judgement for a national court in an EPC contracting state was cited by the proprietor as evidence in the proceedings before the EPO.
The proprietor’s point of view
In reply to the appeal, the proprietor cited a judgement “C/09/654337 /HAZA 23-858”, (cf. English translation) of the District Court of The Hague, cf. English translation. The proprietor insisted upon the fact that the Dutch court upheld the EPO MR in The Netherlands, following invalidity proceedings brought by Synthon.
The board’s decision on the admissibility of the Dutch judgement
The Board observed that the instances of the EPO may generally take notice of decisions from other jurisdictions, either ex officio or following the submission by a party. This applies in particular to the Dutch decision.
The board acknowledged that it is a court decision from a contracting state on the validity of the same European patent, in view of the same prior art as that under consideration in the present appeal proceedings.
However, due to the nature of legal proceedings, the facts and outcome of a decision from another jurisdiction cannot to be regarded as evidence on which a pending case is to be decided.
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The board made clear that a judgement from a national court cannot be taken as evidence in an appeal proceedings before the EPO. The EPO will decide independently of any national decision. It is this thus right so, as every jurisdiction is free in its evaluation of evidence submitted by the parties.
One can thus expect, that a similar stance will be adopted towards decisions of the UPC.
In decision UPC_CoA_22/2024, commented on this blog, the UPC-CoA made it abundantly clear that, in the interests of harmonisation, it actually requires the subsequently deciding organ, to take over what has been decided by the first deciding organ. In other words, the UPC requires the EPO to follow the case law of the UPC.
In view of the different time limits in the different procedures, the UPC will always decide first. This has nothing to do with harmonisation, it is simply requesting supremacy of the UPC over EPO.
The proponents of the UPC wanted it to become the ruling court in Europe in matters of validity and infringement, but the autonomy of national jurisdictions in EPC contracting stares and of the EPO cannot be put into question.
In spite of it might think of itself, the UPC has not the status of the EUCJ and will never have it.
In the present case, Synthon has requested acceleration of the procedure before the EPO in view of the Dutch decisions and due to the fact that national proceedings in Spain and Italy are ongoing.
Diverging decisions
If all jurisdictions come to the same final decision on a given patent, there will not be a problem. If different jurisdictions arrive at divergent decisions, the situation will become problematic, not to say inextricable.
If the decision of a national jurisdiction is different from that of the EPO, the situation of the parties will be uncomfortable, but still manageable. If the UPC and the EPO come to different conclusions, the situation might become critical.
If the EPO revokes the patent, then any decision of a national or supranational court becomes irrelevant as the patent will be dead, but the party having been held infringing will require compensation. If a national court or the UPC revokes a patent maintained by the EPO, then it is the proprietor which will require compensation.
That in pre-UPC times, the question could be considered manageable as it did not affect a lot of other countries, but with the UPC and its long-arm pretention, not only in geographic terms, but also backwards in time, and even for countries having left the UPC, the question will become critical.
In France no compensation is foreseen in such a case, and in a conference at CEIPI on two years of UPC, the chair of the CoA UPC bluntly said, that the French solution will be adopted.
It might not be as easy as he thinks. I take bets that at the end of the day, the CJEU will have something to say, as it engages the liability of the UPC, cf. Art 22 UPCA.
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