Peripheral Decisions in the Lyrica (pregabalin) Saga


As reported in the October edition of On The Pulse, on 10 September 2015 Arnold J found Warner-Lambert’s patent for the use of pregabalin in the treatment of, inter alia, neuropathic pain (the “Patent”) partially invalid on the ground of insufficiency and in any event not infringed by Mylan’s and Actavis’ skinny label pregabalin medicines (the “September Judgment”). Both validity and infringement are currently being appealed. Following the September Judgment, there have been two significant developments. First, on 4 November 2015, Arnold J injuncted Sandoz and leading UK pharmacy chain, Lloyds, from further dealing and dispensing respectively of Sandoz’ full-label generic pregabalin product (“Pregabalin Sandoz”) which had been launched in the wake of the September Judgment.  Secondly, on 25 November 2015, Arnold J struck out Warner-Lambert’s application to amend the Patent as an abuse of process.  This article briefly considers both decisions.

Interim Injunction:  Warner-Lambert v Sandoz and others [2015] EWHC 3153 (Pat)

Following the September Judgment, Sandoz launched Pregabalin Sandoz without notice to Warner-Lambert. Over 100,000 packs, representing enough to supply the market for three months, were sold to a wholesaler and then to Lloyds. On 3 October, Birss J granted an ex parte interim injunction preventing Sandoz from making any further supplies and at a subsequent hearing on 6 October, an Order compelling Lloyds to notify its pharmacies that Pregabalin Sandoz should not be dispensed.

On 4 November, following a more detailed consideration of the issues at a hearing on 21 October, Arnold J granted an interim injunction which will remain in force until determination of infringement at an expedited trial or final determination of validity of the patent in suit following the outcome of the appeal of the September Judgment.  Applying the approach to Swiss Form claims favoured by Floyd LJ in the appeal of Arnold J’s refusal of an interim injunction in the Actavis/Mylan proceedings, Arnold J held that (i) acts carried out in the UK (packaging and labelling) could amount to “preparation of a medicament” and could therefore fall within the scope of the claim; and (ii) it would have been foreseeable to Sandoz at this “preparation” stage that there would be an intentional administration of Pregabalin Sandoz to treat neuropathic pain.

Arnold J placed weight on the quantity of pregabalin supplied by Sandoz, which represented significantly more than would be required to fulfil prescriptions for the non-patented indications and that Sandoz had not “carved out” the patented indication.

Interestingly, in considering the balance of convenience Arnold J held that while it was unnecessary for Sandoz to have brought its own revocation action in view of the ongoing proceedings concerning the validity of the Patent, the launch of Pregabalin Sandoz did raise a distinct issue on infringement not addressed by those proceedings. As it had been open to Sandoz to seek a declaration of non-infringement in relation to Pregabalin Sandoz, and it had not, Sandoz had failed to “clear the way”.

In relation to the Pregabalin Sandoz in Lloyds’ possession, Arnold J held that if there was an arguable case that Sandoz infringed the Patent, then it followed that there was an arguable case that Lloyds infringed under section 60(1)(c) of the Patents Act 1977 i.e. by dealing in a product obtained from the patented process. Furthermore, Lloyds’ state of mind was irrelevant in this regard. The fact that a contractual provision provided that Sandoz was to reimburse Lloyds in the event that it was injuncted persuaded Arnold J that the balance of convenience was in favour of granting the interim injunction against Lloyds.

This judgment reiterates that a first instance finding of invalidity does not necessarily mean that generic pharmaceutical companies have cleared the way for launch.  The judgment is also noteworthy for Arnold J’s consideration of the knowledge and intention requirements for infringement of Swiss Type claims and how this seemingly differs between full-label and skinny label generics notwithstanding the existence of NHS guidance that should, if it was functioning effectively, have prevented the dispensation of generic pregabalin for the patented indication in both scenarios.

Abuse of Process:  Generics (UK) t/a Mylan v Warner-Lambert [2015] EWHC 3370 (Pat)

In the September Judgment, Arnold J construed “neuropathic pain” as covering both peripheral and central neuropathic pain.  The lack of data relating to the latter meant that the claim was not enabled over its breadth and was therefore held to be insufficient. Following Arnold J’s finding of invalidity, Warner-Lambert made an application to limit the claim to peripheral neuropathic pain.  Arnold J held that Warner-Lambert had been in a position to make a conditional application to amend at an earlier stage in the proceedings.  To allow the amendment to proceed after the finding of invalidity would have necessitated a second trial to permit Mylan and Actavis to adduce further evidence.  As Arnold J pointed out, at first instance “the sub-class of peripheral neuropathic pain was not a target which Mylan and Actavis had to hit”.  As such, the late application to amend amounted, in the Judge’s view, to unjust harassment of the counterparties and the application was struck out accordingly.

As Arnold J sets out in his judgment, the abuse of process allegation relies on a line of case law preventing re-litigation in cases which do not amount to strict res judicata which derives from the 19th Century decision in Henderson v Henderson.  Jacob LJ summarised the principle in Nokia v IPCom as follows: “a party should  normally not be allowed to advance in a second proceeding matter he could have advanced in the first”.  This judgment serves as a reminder to patentees to ensure that appropriate fall-back positions are put before the Court at a sufficiently early stage in proceedings.

The appeal of the September Judgment will be heard in May 2016.

Steven Willis & Zinovia Chatzidimitriadou