Warner-Lambert LLC v (1) Actavis Group PTC EHF, (2) Actavis UK Ltd, (3) Caduceus Pharma Ltd v National Health Service Commissioning Board (Respondent) v (1) Teva UK Ltd, (2) Generics (UK) Ltd, (3) Dr Reddy’s Laboratories (UK) Ltd, (4) Consilient Health Ltd, (5) Sandoz Ltd, (6) Department of Health (Interested parties), Patents Court, 2 March 2015, [2015] EWHC 485 (Pat), Arnold J
In a previous judgment (reported on EPLAW Patent Blog on 29 January 2015, which may be read here), the English Patents Court dismissed an application by Warner-Lambert for an interim injunction in respect of Actavis’ generic pregbalin. In this latest judgment, the Patents Court ordered a third party, the NHS Commissioning Board (“NHS England”), to issue guidance that pregbalin should be prescribed by reference to the brand name Lyrica® when prescribed for the patented indication (being neuropathic pain) and, when prescribed for non-patented indications, should be prescribed by reference to the generic name.
NHS England is to issue the guidance to the Clinical Commissioning Groups and the NHS Business Service Authority, those being the bodies responsible for providing such guidance to prescribing doctors and community pharmacies respectively.
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Arnold J held that the court did have jurisdiction to make such an order under its inherent jurisdiction and he cited his decision in Cartier v B Sky B. Arnold J considered whether the principle established in Norwich Pharmacal was relevant in these circumstances, but in the end was satisfied that it was analogous. He said that Norwich Pharmacal relief is available where there is an arguable case of wrongdoing based on the evidence available and such equitable protective duty (and analogous duties) could be enforced by injunction in parallel circumstances.
It was relevant that Arnold J had previously declined to strike out Warner-Lambert’s claim under section 60(1)(c) of the Patents Act as it was a developing area of law and that the Court of Appeal had granted Warner-Lambert permission to appeal against the earlier dismissed application for an interim injunction. Arnold J thought that this latter factor was analogous to situations where an injunction is sought pending appeal after the patent had been held invalid at first instance (Novartis v Hospira).
The court needed to be satisfied that the order was proportionate and caused no barrier to legitimate trade of the generic companies. Arnold J said he was satisfied that this course of action was the most efficacious and cheapest solution to the problem and also the least onerous, as the alternative for Warner-Lambert would be to seek interim relief against all the generic suppliers resulting in them being kept out of the market for non-patented indications, thereby raising costs for NHS England.
Finally, it was relevant that the order contained appropriate safeguards, which included a provision that the order would cease to apply if the Patent is revoked, that any of the parties had liberty to apply if they considered that the pregbalin guidance should be varied and that there were appropriate cross-undertakings in place. Arnold J held that the benefit of the cross-undertaking would be applied to Teva, Actavis, Dr. Reddy’s and all companies within their respective groups, on account of possible future corporate restructuring (Actavis v Boehringer). The benefit of the cross-undertaking was not applied to Mylan, Sandoz or Consilient, who did not request it.
Read the decision (in English) here.
Head note: Jake Hayes, Marks & Clerk Solicitors
