In Actavis v ICOS Lewison, Kitchen and Floyd LLJ held that ICOS’s patent EP (UK) 1,173,181 was invalid for obviousness overturning the first instance decision of Birss J. That decision by the Court of Appeal led to Eli Lilly (the marketing partner of ICOS for tadalafil/Cialis) applying to the Patents Court for an interim injunction against the launch of generic tadalafil at 2.5mg and 5mg doses: Actavis & Others v ICOS & Eli Lilly [2017] EWHC 2880 (Pat).
This is an unusual case of a first instance judge, Mr Justice Henry Carr, hearing argument on whether Lilly has a real prospect of success in appealing the Court of Appeal’s decision to the Supreme Court. The Court of Appeal had refused permission but Lilly is petitioning the Supreme Court. However, no decision from them is expected for several months.
An interim injunction has previously been granted against generic launch following a finding that a patent was invalid, but only when permission to appeal had been granted: Novartis v Hospira [2013] EWCA Civ 583. In that case Floyd LJ said that the court must (i) consider whether the appeal has a real prospect of success; (ii) not investigate the strength of the appeal; (iii) assess the relevant circumstances irrespective of any interim injunction decision pre-judgment; (iv) consider the injustice to both sides; and (v) arrange matters so that the appeal court is best able to do justice between the parties once the appeal has been heard.
Therefore, Carr J first considered Lilly’s arguments on the merits judged against the “real prospects of success” test for an appeal. He reviewed the Court of Appeal judgment, in particular the analyses by Kitchin LJ and Floyd LJ, and came to the view that there was no real prospect of success. Carr J considered that it was simply an application of the facts to existing and settled principles of law.
He then continued to consider factors regarding the balance of damage to the parties. First, Lilly argued that there would be unquantifiable loss due to the usual price spiral. The price spiral was accepted by the claimants but that this lead to an unquantifiable loss was disputed. Given a concession by the claimants regarding arguments on pricing, Carr J held that the quantification of loss to Lilly would be relatively easy.
Carr J also considered that quantification of the claimants’ loss would be very difficult in the present circumstances. This decision rests upon the fact that the claimants have “first mover” advantage in the market if they enter now. He also took into account the way that generic companies bundle products meaning it is difficult to quantify loss of sales across the generic companies portfolio.
A copy of the judgment can be found here.
Headnote: Ian Turner, Marks&Clerk Solicitors LLP
