The High Court refused Gilead Sciences Inc and Gilead Biopharmaceutics Ireland UC’s applications for interlocutory injunctions that would have restrained Mylan and Teva from selling generic versions of Truvada in Ireland while the underlying proceedings continued.
In a judgment delivered on 7 November 2017, Mr Justice Brian McGovern held that damages would be an adequate remedy for the plaintiffs if the injunctions were refused. The decision was interlocutory: the court did not determine whether the Irish supplementary protection certificate (SPC) was valid or whether any generic product infringed it.
The applications concerned Irish SPC No. 2005/021, covering the combination of tenofovir disoproxil (TD), or its salts, with emtricitabine (FTC). The certificate was due to expire on 23 February 2020. Gilead’s underlying patent had expired on 25 July 2017. The plaintiffs sought orders restraining infringement and the making, offering, sale, use, importation or stocking of allegedly infringing products, along with delivery up and disclosure orders.
The two proceedings involved generic products associated with Mylan and Teva. The plaintiffs said the companies were preparing to launch without challenging the Irish SPC. The judgment records that Mylan had obtained pricing approval and said it would not launch before the patent expired; Teva had confirmed an intention to launch on or after that expiry. Neither had initiated Irish proceedings to revoke or challenge the SPC, although both had challenged equivalent certificates in other jurisdictions.
The judge found that the plaintiffs had shown a serious question to be tried. But he rejected their arguments that losses from generic entry would be too difficult to calculate. Evidence before the court described Truvada as being dispensed through seven specialist hospital centres to about 1,200 HIV patients. The judge considered sales data could help trace volumes and assess lost profits. He also found no current market for pre-exposure prophylaxis (PrEP) to include in the damages assessment, and rejected the argument that possible price reductions or sales by multiple generic companies made losses unquantifiable.
The court also considered evidence that Truvada had generated global revenue of more than US$13.8 billion over the preceding four years, alongside an estimate that bringing a product to market in 2016 cost about US$2.87 billion. The judge treated those figures as one factor in assessing whether damages were adequate; they were not a finding on the validity of the SPC.
Because damages could be assessed and the defendants could meet an award, the court refused both applications for interlocutory relief. It did not proceed to decide the remaining balance-of-convenience issues, including Teva’s claim about losing a first-mover advantage. The judgment noted that the cases were in the Commercial List and could be case-managed towards an early trial.