The Swiss-based pharmaceutical giant Novartis is taking the state of India to court in a case that has, after rumbling about in the lower courts for six years, wound up as a very public litmus test of the legal framework sustaining India’s generic drugs revolution.
With the case due before the Supreme Court on 28 March, the fate of millions who depend on affordable Indian medicines may soon hang in the balance.
At first glance, the case concerns the fact that Novartis has been denied a patent for one of its blockbuster anti-cancer drugs, Glivec, in what is one of the world’s fastest-growing drug markets.
But at stake is really that part of India’s domestic patent law, known as Section 3d, which was originally used to deny the patent to Novartis. Section 3d specifically prohibits the practice of ‘evergreening’, whereby pharmaceutical companies make small changes in the chemical makeup of a drug in order to secure further patent protection on essentially the same medicine.
As a result, Section 3d has, since India became fully TRIPS (trade-related aspects of intellectual property rights) compliant in 2005, helped to sustain the growth of India’s generics manufacturers, some of whom currently produce versions of Glivec for less than a tenth of the price. By keeping foreign monopoly interests at bay, Section 3d plays an important role in enabling India to supply life-saving medicines used in poor countries the world over.
All this is reasonably watertight, legally speaking. Yet because of the way that their initial attempt to obtain a patent for Glivec was sent packing by a lower body, the Indian Patent Appellate Board, Novartis have managed to engineer the present, somewhat higher stakes showdown in the Supreme Court.
The Appellate Board decision upheld an earlier ruling by India’s Patent Board stating that, under Section 3d, Novartis had no right to extend its patent on Glivec: that it was simply a case of evergreening. Yet in doing so the Appellate Board made the slip of acknowledging that Glivec was novel in some respects. Specifically, the version of Glivec that Novartis wants to patent in India has greater bioavailability, making it more easily absorbed within the body. But this still wasn’t novel enough, the Appellate Board confirmed, to escape the reach of 3d.
Nonetheless this gave Novartis hope that if it couldn’t get Glivec over the hurdle of Section 3d because the drug itself isn’t novel, it might nonetheless get around Section 3d by loosening the definition of what ‘novel’ is.
The Appellate Board’s decision opens the door to this possibility by no more than the smallest of fractions, since any impartial observer ought in all reasonableness to agree that a novel medicine is one that has a novel clinical effect. Otherwise it’s just packaging and, as patients, we have no reason to be particularly interested in it.
But if what Novartis are arguing is not all that different to saying that if you down a can of Coke rather than drink it slowly the Coke itself is somehow better, the difference in the two earlier verdicts still leaves a chink in the Indian government’s armour. And the danger, both for patients who currently rely upon affordable versions of Glivec in India, and those around the world who rely upon other affordable drugs that Section 3d makes possible, is that woollier arguments than this have been held up in courts before. So we are to hope, therefore, that the Indian government has good lawyers.
Médecins sans Frontières have launched a campaign to stop Novartis.