The Mint and other Indian media outlets have reported that India’s drug regulator has finally given marketing approval to Ranbaxy for its new anti-malarial drug Synriam. We had previously blogged about Synriam over here, here and here.
The drug is a Fixed Dose Combination (FDC) of “arterolane maleate 150 mg and piperaquine phosphate 750 mg drug”. Arterolane was invented by a global team headed by Prof. Vennerstrom consisted of researchers from University of Nebraska (USA), Monash University (Australia), the Swiss Tropical Institute & Hoffman La Roche. The initial research was funded and co-ordination by the non-profit Medicines for Malaria Venture (MMV), which also owns the Indian patent for the drug – IN 245779.
MMV had reportedly invested closed to $20 million dollars in the project. Ranbaxy and MMV had signed a MoU, almost a decade ago for the development of this drug before parting ways in 2007. Thereafter both parties went their own way but not before MMV gave Ranbaxy a royalty free licence to exploit the patent for Arterolane worldwide. After this split Ranbaxy reportedly invested about $30 million dollars of its money along with a $1 million dollars contribution from the Department of Science & Technology (DST) for carrying out extensive Phase III clinical trials in India under Professor Neena Valecha. The Phase III clinical trials were reportedly successful last year and Ranbaxy had announced the launch of the drug on April 25, 2012 – World Malaria Day.
It has taken more than a year since then for Ranbaxy to get a final go ahead from the Indian drug regulator. The launch of Synriam is certainly a landmark event for the Indian drug industry but it also raises the question of IP protection for the drug in question. Will MMV be ready to licence the drug to other Indian generics willing to manufacture the drug? More importantly will MMV willingly to sue any other Indian company which decides to manufacture the drug without permission? Most importantly though, how does Ranbaxy intend to protect its $30 million dollar investment in the drug, if MMV is reluctant to enforce its patent, especially since India does not have a data exclusivity law which would have otherwise protected Ranbaxy’s investment?