
Fourth, patent offices usually don’t know when there is an innovation, incremental or otherwise, and this is where the role of pre-grant third party opposition becomes important. This is what prevented the Novartis patent in 2006. But don’t jump to the conclusion that opposition was for altruistic reasons. Domestic pharmaceutical companies are in it for money just as Novartis is. One element of the Novartis fight was about the case in Madras High Court, where Novartis challenged TRIPs-compatibility of Section 3(d). I haven’t understood the rationale for Novartis filing this writ petition in the Madras High Court. Surely, this was outside its jurisdiction and is a WTO dispute settlement issue. Indeed, that’s precisely what the court has said.
We also have a patent cell in the Intellectual Property Appellate Board and in the second element of the fight, Novartis has challenged the patent refusal decision there.
Fifth, we shouldn’t confuse pricing decisions where fixed costs have to be recouped with those where there aren’t significant fixed costs. Exaggerating a bit, that’s like comparing the costs of making a new Bollywood film with making a DVD. Of course, generics are cheaper and it makes a difference to 7,000-odd Indian patients who use imatinib. Incidentally, if there is a patent, generic manufacturers won’t have to close down, unlike the pre-2005 scenario. Because of a grandfather clause inserted in 2005, they can continue to produce, except that they have to pay reasonable royalties to Novartis.
Sixth, in this heat and dust, we are missing the core issue. Not because of external pressure but because of endogenous reasons and strengths in pharmaceutical research, does India want to protect incremental innovation? As the Technical Expert Group on Patent Law (Mashelkar Committee) pointed out, incremental innovation is not the same as ever-greening. It is bizarre that an IPR report should be withdrawn and go out of circulation because of alleged IPR violation. And we are still ducking the core issue. Do we want to protect incremental innovation because it is good for us, regardless of what WTO, Novartis or the US believes?