The Indian Patent Office has refused a patent to Vertex Pharmaceuticals for its cystic fibrosis drug Orkambi.
The rejection of the International Patent Application (No. PCT/US2008/085456) covers solid forms of lumacaftor one of the active ingredients in Orkambi which to date has been launched onto the market only in the US and Germany.
The ruling could mean that generic versions of Orkambi become available in India even as Vertex is still rolling out its product in other world markets.
Orkambi combines another Vertex CF treatment – Kalydeco (ivacaftor) – with lumacaftor in order to tackle two different genetic mutations in the disease.
Analysts have suggested it could eventually become a $5bn-a-year product, thanks to a list price of almost $260,000 a year. In 2015 Kalydeco and Orkambi brought in $632m and $351m, respectively.