India, Novartis and Antibiotics

Disclaimer – I am certainly not a patent lawyer and can’t even play one on TV.  But this is an important story that we should all try and understand.

In a recent decision on Novartis’ patent for Gleevec, an anti-cancer drug, India’s Supreme Court ruled that its patent was invalid.  Gleevec, like some anti-viral drugs, is a miraculous controller of (but does not cure) chronic myelogenous leukemia, an otherwise fatal disease.  The drug must be taken chronically.  In the developed world, it sells for up to $70,000 per year while the generic version manufactured in India sells for $2500 per year according to the New York Times. The question is – is this ruling anomalous and specific for this particular situation or does it have serious repercussions for patients, physicians and the pharmaceutical industry beyond Gleevec itself?

The ruling is based on section 3 of India’s 1970 patent law, which states that a new form of a molecule that does not show increased efficacy cannot be patented. India passed a new patent law in 2005 to bring it more in line with those of World Trade Organization countries, but apparently limited this new law to drugs patented after 1995. Gleevec’s original patent was filed in 1993 (alpha crystal) followed by a separate patent for a different crystalline form (beta crystal) in 1998 in India (and elsewhere).  The beta form, it claimed, was superior for manufacture and made the alpha form obsolete. This argument is accepted for patentability by World Trade Organization member states. But since the new crystalline form apparently did not show or was not studied for increased efficacy compared to the original form, it was ruled that it was outside the 2005 and the 1970 patent laws in India and therefore not patentable.

The court in India was asked to provide a balance between India’s status as a trading partner in the world and its position as the pharmacy for the developing world. India is an important manufacturer of generic drugs for the developing world.  The New York Times noted that 80% of the active ingredients of all drugs are now manufactured in India and China.

At the same time, India, China and a number of emerging economies in Asia and elsewhere are rapidly growing markets for pharmaceuticals (at least until last year).  Bayer’s deal with Trius for sales of their antibiotic that just completed its phase III trials is an example of the industry recognition of this fact. This growth comes in large part from home-manufactured generics but also comes from multi-national branded products.  The reason for the latter is that there is a growing middle class population in these countries that can afford to pay for branded drugs and recognize that their home-grown generics are of variable quality.  An example of this is the fact that the FDA recently withdrew approval for 27 generic drugs in the US manufactured by Ranbaxy, an Indian generic manufacturer, for quality problems. Europe has done the same.

But for the industry to be able to have access to these growing markets, their patents will have to be recognized. If the markets of emerging economies are isolated from the rest of the world, they may have access to cheaper medicines, but those medicines may also be more dangerous and less well regulated than branded products. Lets also remember that generic companies do not develop new drugs.  Pharmaceutical companies that brand new products develop new drugs.  Without access to these emerging markets, the pharmaceutical industry will undergo even further consolidation and cost cutting.  This will of necessity lead to less research and fewer new drugs for all of us.  Is this the outcome that India wants?  Do any of us want this? 

We clearly need a pathway for those less fortunate in the world to have access to new medicines while at the same time preserving intellectual property.  The pharmaceutical industry has tried (perhaps not so successfully) to address with with various rebate and price reduction programs. They probably need to try harder. 

In the case of antibiotics per se – India is the epicenter of antibiotic resistance in the world.  NDM-1, one of the most resistant super-resistance elements around was born there and is endemic there.  It is spreading from India to the rest of the world. Does India want to risk being without needed new antibiotics to fight these infections?  Do any of us?

So lets hope that the Gleevec decision is an isolated one and that the industry will not see this as a retrenchment in India but rather as an anomaly.