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Warner-Lambert Company LLC v Sandoz GmBH, Sandoz Limited and Lloyds Pharmacy Limited, England and Wales Patents Court (Arnold J), London, UK, 4 November 2015, Neutral Citation Number: [2015] EWHC 3153 (Pat)

This judgment concerned an application for an interim injunction restraining Sandoz from any further dealing in its full label generic pregabalin product and Lloyds from dispensing the quantities of that product that it had acquired prior to the grant of a temporary restraining order by Birss J.
The interim injunction was granted by Arnold J and will remain in force until determination of infringement at an expedited trial or final determination of validity of the patent in suit in proceedings between Warner-Lambert on the one hand and Actavis and Mylan on the other.

The background to this judgment is protracted and complex. Pfizer (under a licence from Warner-Lambert) markets pregabalin in the UK under the brand name Lyrica for the treatment of epilepsy, general anxiety disorder and neuropathic pain. The patent protecting pregabalin per se (the “Compound Patent”) has expired and the associated SPC has lapsed. Warner-Lambert also has a patent for the use of pregabalin in the treatment of pain (the “Patent”).

Following expiry of the Compound Patent, a number of generics have launched pregabalin with skinny labels, which do not include reference to treatment of neuropathic pain. By an Order dated 26 February 2015, Arnold J compelled NHS England to issue guidance to the effect that practitioners should prescribe pregabalin for neuropathic pain by reference to the brand name Lyrica and by reference to INN for all other indications (“the NHS Order”). This was intended to allow Warner-Lambert to maintain a monopoly over the patented indication and to allow generic competition in respect of the non-patented indications.
By judgment of 10 September 2015, Arnold J held the Patent for the most part invalid and not infringed by Actavis’ or Mylan’s skinny label pregabalin medicines (“the September Judgment”). The parties to that action have subsequently been given permission to appeal Arnold J’s findings on both validity and infringement. As such, Arnold J’s declarations concerning the validity of the Patent are stayed pending determination of the appeals and the Patent remains in force. As Arnold J makes clear in his judgment, the NHS Order also remains in force.

Following the September Judgment, Sandoz launched a full-label pregabalin product (“Pregabalin Sandoz”) without notice to Warner-Lambert. Over 100,000 packs, representing about three months’ supply, were sold to a wholesaler and then to Lloyds. On learning of this supply, Warner-Lambert made an urgent application for an interim injunction preventing Sandoz from making any further supplies, which was granted by Birss J by telephone on the evening of Saturday 3 October. At a subsequent hearing on 6 October, Birss J granted an Order compelling Lloyds to notify its pharmacies that Pregabalin Sandoz should not be dispensed.

As there had been no (or insignificant) dispensing of Pregabalin Sandoz, Arnold J considered that he could assess the interim injunction application as if Sandoz were not yet on the market. Insofar as the application related to Sandoz, Arnold J noted that the application was complicated by the existence of three different contingencies, namely the outcome of infringement proceedings between the parties, the outcome of the appeals against the September Judgment and the outcome of an application by Warner-Lambert to amend the Patent, which has been resisted by Actavis and Mylan.

Arnold J, applying the construction of Swiss-type claims favoured obiter by Floyd LJ in the appeal of Arnold J’s refusal to grant an interim injunction in the pregabalin litigation involving Actavis, held that there was an arguable case 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 involved, 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.

On considering the balance of convenience, Sandoz argued inter alia that, on the basis that the NHS Order would mean that Pregabalin Sandoz would not be dispensed for the patented indication and that there was unlikely to be a price depression before the expedited infringement trial, the usual presumption that the balance of convenience should favour the originator did not apply. Arnold J disagreed, noting inter alia that the guidance was not yet fully effective in England and had not been issued in Scotland.

Furthermore, the presence of a full-label generic pregabalin product would increase the likelihood of a drug tariff recategorisation leading to a price decrease. Arnold J also considered the parties’ submissions on the “clear the way” doctrine and 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”. Arnold J ultimately held that the balance of convenience favoured the grant of the interim injunction against Sandoz and it was so ordered.

In relation to the Pregabalin Sandoz in Lloyds’ possession, Arnold J declined to make an interim order based solely on the Court’s discretion enshrined in section 37(1) of the Senior Courts Act 1981; there was no prospect of Lloyds aiding infringement by a third party or being mixed up in any infringement downstream from itself, as the patients to whom Pregabalin Sandoz would be dispensed would have a defence to patent infringement under the private and non-commercial use exemption provided for in section 60(5)(a) of the Patents Act 1977.

On Warner-Lambert’s alternative case, that Lloyds’ dispensing of Pregabalin Sandoz would infringe the Patent, 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. As Arnold J had pointed out in the September Judgment, Lloyds’ state of mind was irrelevant in this regard. The balance of convenience also favoured Warner-Lambert; the fact that a contractual provision provided that Sandoz was to reimburse Lloyds in the event that it was injuncted was persuasive. As such, the interim injunction against Lloyds was also granted.

Read the decision (in English) here.