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Australia – No Reason To Believe: The Federal Court Refuses Interlocutory Injunctive Relief.

23 April, 2014

 

 

Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241

 
What You Need To Know

 

  • Warner-Lambert Company LLC applied to the Federal Court of Australia for an interlocutory injunction restraining supply of Apotex Pty Ltd’s generic pregabalin product. Although registered for the treatment of seizures only, Warner argued Apotex had reason to believe that its product would be prescribed to treat pain, infringing a method of treatment patent owned by Warner.
  • On 14 March 2014, Justice Griffiths dismissed Warner’s application, finding that it had failed to establish a prima facie case of infringement under section 117 of the Patents Act 1990 (Cth) and that the balance of convenience favoured Apotex.
  • This case is the first to apply the High Court of Australia’s decision in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, in which the High Court held that the registered indications for a generic pharmaceutical product operated as an “emphatic instruction” concerning the permissible use of that product.

 
Background

 
Warner-Lambert Company LLC (Warner) is a member of the Pfizer group of companies. Pfizer group companies hold two patents relating to the drug pregabalin, the first concerning the treatment of pain (Pain Patent) and the second concerning, relevantly, use of pregabalin to treat seizures (Seizure Patent).

 
In 2005, Warner obtained registration of pregabalin on the Australian Register of Therapeutic Goods (ARTGunder the name LYRICA for the treatment of neuropathic pain and seizures. In March 2013, LYRICA was listed on the Pharmaceutical Benefits Scheme (PBS), for the treatment of neuropathic pain only.

 
In September 2012, Apotex obtained ARTG registration of a generic pregabalin product. Originally, the registered indications for Apotex’s product included both the treatment of neuropathic pain and seizures.

 
Apotex commenced Court proceedings in mid-2013 seeking revocation of the Pain Patent and of the Seizure Patent. However, the part of that proceeding relating to the Seizure Patent was discontinued, by consent, in October 2013. In that month, the registered indications for Apotex’s pregabalin product were narrowed: the neuropathic pain indication was deleted, leaving only the seizure indication. Apotex’s product is not listed on the PBS.

 
In February 2014, Apotex gave notice that it intended to commence marketing its pregabalin product for the treatment of seizures. Relying on the Pain Patent, Warner applied to the Court for an interlocutory injunction, which would restrain supply of Apotex’s product until final hearing. Apotex consented to orders preventing marketing or supply of its product for the treatment of neuropathic pain, but argued that supply of its product for the treatment of seizures would not infringe the Pain Patent. For the purposes of the interlocutory proceedings, Apotex did not challenge the validity of the Pain Patent.

 
Prima Facie Case

 
Warner argued that, although Apotex’s product was registered for the treatment of seizures only, Apotex nevertheless had reason to believe that its product would be used for the treatment of neuropathic pain. If Apotex were found to have reason to believe that its product would be used in that manner, then supply of the product in Australia would infringe the Pain Patent pursuant to section 117 of the Patents Act 1990 (Cth) (Act).

 

Warner sought to establish that there is no market in Australia relating to the use of pregabalin in seizure management, so that Apotex’s product would inevitably be supplied to treat pain. However, Justice Griffiths did not accept that submission. His Honour noted that, in 2005, Warner had itself applied (unsuccessfully) to have LYRICA’s PBS listing extended to cover the treatment of seizures.

 
Warner also contended that pharmacists, being aware that Apotex’s product was bioequivalent to LYRICA and had originally been registered for the treatment of both seizures and pain, would substitute Apotex’s product for LYRICA, regardless of the condition for which pregabalin had been prescribed.

 
In assessing whether Apotex had reason to believe its product would be used to treat pain, Justice Griffiths considered the recent decision of the High Court of Australia in Sanofi-Aventis. In that case, the High Court explained that regard must be had to the regulatory regime for pharmaceuticals in Australia and held the registered indications for a generic pharmaceutical product operated as “emphatic instructions” to doctors and pharmacists concerning the manner in which the product could be used.

 
Justice Griffiths placed weight upon promotional materials and letters which Apotex proposed sending to doctors and pharmacists, highlighting that its product is not indicated for the treatment of neuropathic pain. His Honour found that, in the circumstances, those express instructions would displace pharmacists’ more general understanding that Apotex’s product was bioequivalent to LYRICA. Justice Griffiths concluded that Warner had not established a prima facie case (or had established only a weak case) that Apotex had reason to believe its product would be used to treat neuropathic pain.

 
Balance Of Convenience

 
Justice Griffiths also found that the balance of convenience favoured Apotex. His Honour found that, if an injunction was refused and Warner was ultimately successful at trial, assessment of its damages would be more straightforward than would be the assessment of Apotex’s damages if an injunction was granted and Apotex ultimately prevailed at trail.

 
In forming that view, Justice Griffiths had regard to evidence from a chartered accountant, highlighting the complexities involving in quantifying any compensation to which Apotex may ultimately be found entitled pursuant to an undertaking as to damages, including the difficulties involved in assessing a hypothetical market and price for Apotex’s product.

 
In considering the balance of convenience, Justice Griffiths also had regard to evidence of Apotex’s solicitor, relating to her experience in ongoing Federal Court proceedings relating to another pharmaceutical product. Apotex’s solicitor described the prolonged delays and very substantial costs involved in an inquiry as to compensation payable pursuant to an undertaking as to damages given in that case.

 
Next Steps

 
On 9 April 2014, Warner was granted leave to appeal to the Full Federal Court from the judgment of Justice Griffiths refusing interlocutory injunctive relief. The appeal is listed for hearing in early May.

 

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For further information, please contact:

 

Ben Miller, Partner, Ashurst
[email protected]

 

Andrew Rankine, Ashurst
[email protected]

 
Stevie Gough, Ashurst
[email protected]

 

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