Fierce Biotech also reports today that the Indian Supreme Court rejected Novartis' bid for a patent on its cancer drug Gleevec. The court said the extended release form of Gleevec, which has never had an Indian patent, failed to meet a hurdle as a new subsance with increased efficacy. Effectively they ruled this represented an instance of "evergreening" by Novartis and rejected its application under section 3(d) of Indian Patent code.
Consumer advocates and biosimilar producers hailed the ruling as a victory to make this drug more available to the Indian populace. Novartis said it the ruling provided heavy disincentives for it to invest in any more R&D work in India and implied it would think twice before marketing anything in India without patent protection secure in hand.
If this became a more generalized phenomenon experienced by other multi-national companies in India, will they as a group choose not to market some of their newer products there? If so, does that mean India will be increasingly relegated to using older (and cheaper) versions of drugs that have had their IP expire effectively. I'm not sure. One could argue this would have a long term negative effect on what is offered for sale in India. On the other hand, people can't use a drug they can't afford to buy in the first place, now can they? This will be worth watching.
In the Fierce Biotech piece, it was also noted that the UK had passed some new tax provisions that will favor R&D investment in the UK -- effectively reducing tax rates on profits from patented products. There is also an above the line tax credit of 10%. The new provisions called the Patent Box were hailed by the BioIndustry Association (BIA) as being a new spur for R&D investment in the UK -- instead of a place like say India.
Investment may well swing back toward the UK, at India's expense for example. But something like this to me is less likely to sway India R&D investment decisions, than the aforementioned patent ruling -- which in itself is less likely to effect R&D investment I think than it is to affect decisions on what products to actually introduce and market in India. That's just me.
Posted by Bruce Lehr Apr 1st 2013.