The Indian Supreme Court has rejected a drug patent application by the international pharmaceutical firm Novartis, an event that merited coverage by the New York Times, BBC and many other media – news which you might think is mostly a matter for the business page or drug industry insiders.
In fact, the case may represent one of the most difficult dilemmas in global health. It is a fight that is far from over.
The Indian high court’s legal resolution (or perhaps ‘latest phase’) of this long-running battle between the Indian government and Novartis, as I wrote about last October in a post called Patents vs the Poor, is regarded on all sides as representing much more than what Novartis can charge for the particular cancer drug, Gleevec (or Glivec), at issue.
What’s at stake is one of global health’s most difficult balancing acts – how to expand access of life-saving medicines to the poor while also protecting the legitimate interests of the drug industry when it comes to patent protection and intellectual property. The high court’s decision is being reported as a victory of the generic drug industry, which is big in India, over Western drug makers. As the New York Times put it:
On the one hand, it will help maintain India’s role as the world’s most important provider of cheap medicines, which is critical in the global fight against HIV/AIDS and other diseases…. On the other hand, the ruling could cost lives in the future. Drug company executives and others argue that India’s failure to grant patents for critical medicines … is a shortsighted strategy that undermines a vital system for funding new discoveries.
That’s what Novartis’ head of corporate research, Paul Herrling, told me:
“If a breakthrough compound like this cannot be patented in India, that has major consequences for innovation in India and elsewhere,” said Paul Herrling. “This isn’t really about Gleevec … This is just one part of a much larger issue.”
Many activists happen to agree with Herrling on that point, that this is just a skirmish in a much bigger battle. But where they part ways is over the turf they are fighting to protect. While Herrling sees the Indian legal decision as a threat to innovation, especially for drug companies in India, others see it as a great victory for poor people and the campaign to expand access to drugs.
“We’ve been working on this for seven years,” said Judit Rius, U.S. manager of Médecins Sans Frontières (aka Doctors without Borders) Campaign for Access to Essential Medicines. “We have a lot to celebrate with this landmark ruling, but we should not assume that we are done with this.”
To begin with, Novartis has been fighting this battle for many years and can be expected to keep fighting – by re-filing the challenge again based on a different legal angle, somehow again appealing the Indian government’s rejection of its patent application for the cancer drug Gleevec.
In 2006, the Indian government first rejected Novartis’ claim for extending its patent protection on Gleevec as an unjustified attempt to ‘evergreen’ its monopoly hold on the drug by making minor chemical changes to the medical formula. Herrling and Novartis contended the chemical modifications were so significant that it deserved a new patent. When that argument was rejected by Indian officials, Novartis instead challenged the validity of the Indian government’s law as a violation of international trade agreements made when India joined the World Trade Organization.
Looling behind this court victory, Rius said, is a new trade agreement being negotiated — mostly in secret — by the Obama Administration known as the Trans Pacific Partnership agreement, or the TPP. Here’s an earlier post about Seattle activists trying to raise awareness of the TPP and a recent guest op-ed. The public and the media has paid little attention to these massive new trade negotiations, but many activists like Rius have been pushing for more open debate about its provisions, especially with regard to drug patents.
“According to leaked documents out of the negotiations, the U.S. government is proposing new regulations that would make it impossible for signatory countries to do what India has done,” Rius said. India is not part of the TPP negotiations, Rius but these kind of hemispheric trade agreements tend to reverberate globally – forcing other countries to adopt the restrictions rather than lose out in terms of trade.
“There are still more battles to come on all of this,” she said.