In a decision handed down late yesterday, Warner-Lambert has been successful in its appeal to the Australian Full Federal Court to extend the interlocutory injunction against Apotex to prevent sales of Pregabalin for the treatment of seizures.
In March 2014, a limited interlocutory injunction was granted to Warner-Lambert preventing Apotex from selling Pregabalin for the treatment of neuropathic pain.¹ However, the injunction did not extend to generic pregabalin indicated for seizures, so Apotex had a limited clearance to sell non-PBS products pending full-trial. Background details for the Warner Lambert v Apotex interlocutory case can be found here.
In April 2014 Warner-Lambert was granted leave to appeal the decision on the basis that the judge primarily erred in dismissing key information in determining the size of the seizure market.
In a Full Court hearing yesterday, Chief Justice Allsop, Justice Jagot and Justice Nicholas surprisingly extended the injunction to include “any product containing pregabalin which is indicated for ‘adjunctive therapy in adults with partial seizures with or without secondary generalization’ (or any substantially similar indication) but is not indicated for the treatment of neuropathic pain (or any sub-category of neuropathic pain)”.
The Court concluded that the ‘seizure’ market was so small that the only market for Pregabalin, in effect, was the ‘pain’ market. Therefore the vast majority of any sales were likely to be for ‘off label’ pain use. Further, Apotex’s discount strategy meant there was a significant incentive for prescribers to make the switch.
The recent High Court decision concerning Leflunomide ² was relied upon at [92] to support the submission that Apotex was entitled to sell pregabalin indicated for a condition outside the ‘limited novelty’ of the pain patent. In the Leflunomide decision, their Honours stated at [304]:
…. it was not shown, nor could it be inferred, that Apotex had reason to believe that the unpatented pharmaceutical substance, which it proposes to supply, would be used by recipients in accordance with the patented method, contrary to the indications in Apotex’s approved product information document.
The decision in the High Court case found that Apotex did not have ‘reason to believe’ and relied upon the fact ‘that the approved production information document for the relevant pharmaceutical product (Apo-Leflunomide) disclosed that it was not indicated for the method of treatment to which the claims of the patent in suit were directed.’ [93] In the present case, however, the court found that whether or not the absence of a pain-related indication for the Apotex product, coupled with Apotex promotional material, was sufficient to avoid infringement under Section 117 (contributory infringement) is not something that could not be resolved before full trial.
This decision brings into question the common practice in Australia of avoiding patent infringement of ‘Method of Treatment’ patents by excluding the offending indication from the product’s TGA registration.
It is not yet known whether there will be an appeal against this decision. However, any appeal to the High Court requires special leave of that court and such leave is rarely granted in interlocutory matters.
If you have any specific enquiries about the pregabalin case in Australia, please contact Paul Jones or Debra Tulloch.
This article was written by Dr Ellen Reid.
¹ Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241
² Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1