A campaign by Ireland's gay and transgender community for access to cheaper drugs to treat and prevent HIV has received a major boost, after pharma giant Gilead lost a court action in Dublin against generics manufacturers.
Gilead has generated almost $14 billion globally in recent years from sales of its blockbuster HIV drug, Truvada. It came off patent in July, but its Irish exclusivity is extended until 2020 by a supplementary protection certificate (SPC).
In July, Gilead initiated High Court action against generics manufacturers Mylan and Teva, who planned to launch generic versions in Ireland upon patent expiry. Gilead sought an injunction blocking them due to the SCP.
This week, however, the court rejected its application for an interlocutory [provisional] injunction, which would have blocked Mylan and Teva until a full trial.
Sources say that the launch of generic versions of Truvada by Mylan and Teva in Ireland is now imminent. They will be up to 60 per cent cheaper.
Access to Truvada and its generic equivalents is at the heart of a passionate campaign in Ireland and abroad. Primarily for men who have sex with other men, the drug has three uses: to treat HIV once contracted; as part of a preventative cocktail taken immediately after possible exposure; and, taken routinely to help reduce the risk of contracting HIV.
The Health Service Executive (HSE) spends about €24 million on Truvada as a treatment and also for immediate post-exposure prophylaxis (PEP) treatment. The State does not, however, fund Truvada for pre-exposure (PrEP) use, which is at the heart of the campaign by advocates for the gay community.
Some studies have shown that taking a PrEP drug as a preventative measure reduces contraction rates among men who have sex with men by 90 per cent.
In its High Court action, Gilead sought the injunction and also for Mylan and Teva to “deliver up” their plans for their products. Mylan responded that it already has “pricing approval” from the State for its generic version, while Teva also said it would not wait on the expiration of the SPC.
SPCs for Truvada are being challenged in several countries across Europe by Mylan and Teva, including the UK, Spain and Germany. They have not sought to revoke the SPC in Ireland. Meanwhile, Gilead failed to get an interim injunction in France, but its SPC was upheld in Portugal.
Mr Justice Brian McGovern rejected Gilead’s injunction application, partly on the basis that if it is found at full trial that the SPC stood and its rights were breached, Gilead could seek monetary damages.
Andrew Leavitt, a member of campaign group Act Up Dublin, welcomed this week's "significant" decision, which he said could "accelerate the timeline" for State-funded PrEP because the generics are 60 per cent cheaper.
He said many gay men order the drug online themselves at a cost of €100 for a three-month preventative supply, but customs often seize it on importation in the post.
“We don’t care who the HSE acquires PrEP from, we just want it available in Ireland,” said Mr Leavitt.
Gilead did not make any comment about the judgment.