Roche has decided to drop its patent fight for Herceptin in India. India had invalidated its patents last week. But rather than keep fighting, and risk that India would force it to grant a compulsory license, Roche has thrown the doors open to all generic challengers. But these folks of course will have to do it themselves and there are no current Herceptin generics looming on the horizon.
Roche had in fact lowered prices for Herceptin in India by linking up with Emcure Pharma to repackage its drug for the local market. But its offered price of $1400/month was not low enough to be accessible to most Indian patients said advocacy groups.
Roche appears to be shifting its strategy for Herceptin by blocking compulsory licensing, letting generic companies see if they can compete, and going to the Indian authorities to lobby for tighter guidelines for approving biosimilars (a tact that it and Amgen have also started pursuing in the US even down to the individual State level). So now expect Roche to pick up the call for India to raise the biosimilar standards.
Don't underestimate Big Pharma's wherewithal and desire to protect its IP through all legal and political means at its disposal. See Pharmalot.
Posed by Bruce Lehr Aug 16th 2013.