Ever-greening Gleevec

This post is not about TERRORIST attack against India; neither is it about POLITICS, nor about CORRUPTION.

The above disclaimer has become necessary as all the other matters are taken to the inside pages of newspapers and given only as briefs on the ticker at the bottom of TV news programs. This is particularly true of matters that are more than half a decade old.

And, this is a story that started about six years ago. It is about “ever-greening” a drug patent. If the issue is new to you, be patient; it still is to me, even after reading about it for six years. You will be no worse than me even if you don’t understand anything! Isn’t that a good place to be?

“Ever-greening” of patents is the game global drug giants play to have a steady stream of profits from a particular drug even after society has compensated the entrepreneur for his risks in developing it, through a monopoly enabled by a patent. The process of not adding any substantive and effective efficiency improvements to an existing drug, yet claiming a new patent, if successful, is called “ever-greening”. The patent is recycled in a new package – as simple as that.

It is about the Swiss pharmaceutical giant Novartis and its cash cow anti-cancer drug, Gleevec. I found an interesting news item in the inner pages of The Hindu of September 6, 2011 (A victory for Novartis could spell death for millions, Priscilla Debraj).

From my (disad)vantage point, and only vaguely remembering an editorial page article about four years ago, I dare to enter the lion’s cage.

Novartis approached the Madras High Court against the Indian patent office conclusion that the “[N]ew salt form [my emphasis] of Gleevec [‘ever-greening’ is at work here!] did not deserve a new patent, since it did not meet the provision of ‘increased’ efficacy”. That is, the patent application falls on the wrong side of Section 3(d) of the nation’s patent law. “Novartis argued that the salt form would have higher levels of availability in the body of the patient.”

I want to take a detour, mainly for comic relief. My boss measures his subordinates’ hard work only by their attendance at the office; not by how much they have produced. Novartis and my boss are apparently identical twins!

Madras High Court did not fall for this argument. It, as reported, clarified that “efficacy” means “‘therapeutic efficacy in healing a disease”. Makes sense. It is against this background the pharmaceutical giant has now approached the Indian Supreme Court. But this time aiming to hit lower, below the belt, it is pleading with the Supreme Court, “[T]o interpret ‘efficacy’ in a way that will allow its patent.” Have you seen a more obvious situation of being asked to put the cart before the horse? I have not. The case must have been argued before the Court on September 6th, as per the news item. I am eagerly waiting to see whether the Court put the cart and horse in their proper places.

There is an interesting sub-plot in this story. The government commissioned a panel headed by a retired government official of high standing in the scientific community to see whether the Indian patent laws correspond with the nation’s commitments under various agreements / covenants / treaties, whatever. The panel came out with a report saying that Section (d) of the Indian patent law may be falling afoul of some IPR stuff.

This would have been fine, except that some hardened cynics wanted to trace the logic of the conclusions in the report. Lo and behold, they landed on a paper written by a researcher on a funded project. Even here, it does not get bad enough. The government report had quoted the research paper, verbatim in places, without as much as a “With your leave”. An IPR violation, sort of, in a government commissioned report by one of the scientific leading lights on an IPR matter! Irony.

But, more is to come. The research report was funded by none other than some pharmaceutical giants (perhaps including Novartis) that would benefit from the conclusions arrived at in the paper. So, one does not need to be too much of cynic to raise her eyebrows while spotting obvious conflict-of-interest. The objectivity of the research is too easy to be questioned. Perhaps that is why it was not questioned!

However, it is impossible not to feel betrayed that an official panel put its imprimatur on this possibly motivated research. Flags must have been raised but they were not. To end this particular episode, the chairman of the panel withdrew his report.

Now, you may ask me, “Why did you expect this piece of news to be anywhere except in the inner pages?”

Gleevec (the generic) sells at about Rs. 8,000 per month. If the patent is awarded, Novartis sells the same drug (in its new salt form) at Rs. 120,000 per month – a factor of 15, if you could do your math without a calculator. This is economic TERRORISM.

It is about POLITICS, because of the way (very underhanded) the government commissioned panel sided with the industry. I have to ask whether the government could have hinted what the conclusion of the report should be, siding itself with the Swiss multinational and not with the Indian generic drug producers (who are also multinationals in their own right, I hasten to add). If you read Swiss bank accounts between the above lines, I plead innocent! Yet, I am not willing to give the benefit of doubt to the government.

If it was not CORRUPTION – quoting the results of an industry sponsored research to draw conclusions favorable to the industry – what would you call the panel’s conclusions?

One does not need to “ever-green” terrorism, politics and corruption. They have existed ever since the dawn of civilization and will not be dead till civilization itself dies, Anna Hazare notwithstanding as he has no time for inside pages.

Raghuram Ekambaram