This was a trial of preliminary issues in a combined action of claims by numerous parties for compensation following from the pregabalin/Lyrica litigation which culminated in the Supreme Court judgment Warner-Lamber v Generics (UK) Ltd (t/a Mylan) [2018] UKSC 56. Andrew Lykiardopoulos QC acted for Actavis and Teva, two of the claimants, and Charlotte May QC acted for Warner-Lambert and Pfizer, the defendants.
Pfizer held the relevant marketing authorisation for Lyrica, the branded pregabalin medicine marketed in the UK. Pfizer was also the proprietor of EP 0 934 061 with claims in Swiss form directed exclusively to the use of pregabalin for treating pain. Actavis and Dr Reddy’s launched skinny label products in 2015, following which Pfizer applied for and was granted an order by Arnold J requiring the NHS Commissioning Board to distribute guidance to GP practices and community pharmacies concerning the circumstances in which pregabalin should be prescribed by the brand name Lyrica as opposed to the generic name pregabalin. Pfizer gave an undertaking to compensate the relevant parties if that order was later found to have caused loss to them. Other parties subsequently sought to bring pregabalin medications to market in the UK; Pfizer gave similar undertakings in support of its successful claims for injunctive relief.
Ultimately the Supreme Court held in 2018 that a number of claims of Pfizer’s patent were invalid, and claims were brought against Pfizer for compensation in accordance with the undertakings it had made. The issue in this trial was what are the appropriate counterfactual assumptions over the period from the expiry of Pfizer’s data exclusivity in July 2014 to the present upon which to determine any damages payable to each of the claimants, and to what extent findings of fact are binding as between different parties in the proceedings.
Zacaroli J held that the appropriate assumption as a matter of law in assessing the counterfactual for each claim was that none of the orders, undertakings or threats had been made. The question whether findings of fact are binding as between different parties raised essentially a case management issue. It was held that the claims should be case managed on the basis that findings of fact will be binding on each of the parties to them. While it was true that each claim is technically a separate claim, that did not mean that the court should permit each claim to proceed as a separate action. The commonality of issues as between the claims, considerations of cost, fairness and efficient use of court time and resources all pointed in favour of common issues being determined on a common basis.