Novartis vs. India: Patents vs. the poor?

Flickr, Brooks Elliott

One of the biggest, thorniest dilemmas in global health is coming to a head in India.

(And the biggest player in this arena, the Bill & Melinda Gates Foundation, with a former top Novartis executive running the global health program, has no comment on it. More on that below).

At one level, it’s a narrow legal battle between the drug company Novartis and the government of India over an expensive cancer drug known in the U.S. as Gleevec, and everywhere else as Glivec.

Novartis has challenged India’s denial of patent protection for the drug and the case is now under consideration by the Indian Supreme Court. Those on either side of the argument say the case has major implications for all of global health.

Why? Because this legal battle pits one set of laudable goals, finding new and better drugs, against another equally critical aim, making sure all the people who need these drugs can afford them.

Paul Herrling
Novartis

“If a breakthrough compound like this cannot be patented in India, that has major consequences for innovation in India and elsewhere,” said Paul Herrling, head of corporate research at Novartis.

“This isn’t really about Gleevec,” added Herrling. “This is just one part of a much larger issue.”

On that last point, many global health advocacy organizations and activists would agree.

Organizations like MSF (Médecins Sans Frontières, aka Doctors without Borders) Oxfam and others focused on ensuring poor people have access to life-saving drugs see Novartis vs. India as central to a much bigger industry-wide push now taking place on a number of fronts.

Judit Rius, MSF

“This is part of a global strategy aimed at lowering the bar, of making it easier for these companies to extend their drug patent monopolies,” said Judit Rius, U.S. manager of MSF’s Campaign for Access to Essential Medicines.

A Novartis win in Indian court would seriously undermine the generic drug industry, Rius said, reducing the supply of cheap drugs that make a life-and-death difference in poor countries.

MSF, Oxfam and other health advocacy organizations have been fighting Novartis on this case for years. It has dragged on within the India court system since 2006, getting filed, denied and then re-filed, with advocates for the drug company arguing that India is improperly protecting its burgeoning generic drug industry while many public health advocates argue Novartis is profit-seeking at the expense of the poor.

Herrling, noting that Novartis already provides the drug free to most Indians, contends that if India does not grant a patent on this drug, global health will suffer along with the drug industry.

“This is also about the protection of innovation in India,” Herrling said.

“The Indian patent system contends this is not a breakthrough drug, something that the patent system of many other countries has already recognized,” he said. “It shocked us when we were denied this patent…. If the law is applied in this way, innovation will suffer.”

Fighting for the pharmacy of the poor

Others, however, say if India doesn’t stick to its guns in denying Novartis the patent it is the poor who will suffer because it opens the door to an illegitimate practice by some in the drug industry known as ‘evergreening‘ – making minor changes to an existing drug to extend its patent life.

Novartis’ Herrling, I should note, says his company also opposes evergreening and that their legal challenge is based on the claim that India is applying its prohibitions too broadly — can we call that overweening anti-evergreening?

Anyway, most commentary out there seems to support India’s claim that Novartis is trying to evergreen Glivec. A recent article in the British medical journal The Lancet is just one recent example of the public health case supporting India’s strategy to protect against this practice.

Rohit Malpani, Oxfam

“India is often called the pharmacy of the developing world because it produces most of the world’s generic medicines,” said Rohit Malpani of Oxfam International.

“Any change made that will undermine India’s ability to produce these drugs has a direct impact on the health and welfare of hundreds of millions of people,” said Malpani. “If Novartis succeeds, it will cripple the generic drug industry.”

Indian drug companies reportedly manufacture something like 70 percent of all generic drugs and 90 percent of the anti-retroviral (ARV) drugs used to treat people living with HIV/AIDS around the world.

Before the Indian generic drug industry, Malpani said, most of those dying at the epicenter of the AIDS pandemic in Africa were priced out of the market. There’s no other way to say it, he said: This killed people. Today, thanks to generic drugs, he said, the cost of ARVs is down to less than $100 per year.

“As a result, we now have 6 million people on treatment and that never would have happened if India had not had the ability to produce these medications at low cost,” Malpani said.

James Love

But much more is at stake here than just getting low-cost anti-AIDS drugs to the poor, says James Love, someone who has worked on the health and justice implications of intellectual property law for more than two decades.

“The Novartis case is just one of a string of cases and actions taken by the pharmaceutical industry to protect profits in a way that denies access to medicines in poor countries,” said Love, director of an organization in Washington, D.C., known as Knowledge Ecology International. “India is under a lot of pressure from the drug industry, and from governments including the U.S. government, to change its approach to drug patent protection in ways favorable to industry.”

Love cited several other cases such as Bayer’s unsuccessful push in India to gain patent protection on another cancer drug, Roche’s equally unsuccessful battle against Indian generics drug firm Cipla and the revocation of a patent on a Pfizer cancer drug. So far, he said, the Indian government and its legal system have been holding firm on their approach to balancing patent protection against the needs of the poor.

“But this isn’t new and it isn’t going to stop,” said Love. “It’s a permanent goal of the drug industry to strengthen and extend its patent protections in these ways that undermine public health, and the needs of the poor.”

Beyond the court cases focused on particular drugs, he said, there is a much bigger struggle going on — mostly behind closed doors — that is also working to enforce stricter drug patent protections as part of a broader set of negotiations known as the Trans-Pacific Partnership which covers all sorts of intellectual property issues. (Here’s one post on the TPP. More on this later)

Gates Foundation: No comment

Love, who is originally from Seattle (and whose father was the first official mayor of Bellevue), said many of those fighting on this front would like to hear from the Gates Foundation on how to resolve this dilemma — of protecting intellectual property without undermining the poor’s access to life-saving medications.

The philanthropy, he said, has championed the health needs of the poor and has also championed “public-private” collaboration. Bill Gates certainly knows all about intellectual property, Love said, and it hasn’t escaped anyone’s notice that the foundation’s new global health director, Trevor Mundel, prior to coming to Seattle was head of global development for Novartis.

Yet the Gates Foundation has so far declined to comment on either the Novartis case or on the general debate over access to medicines vs drug company patents.

The philanthropy is active on this front, if not so public about it, with a number of in-house experts working on intellectual property issues and often requiring ‘global access’ agreements with drug companies or researchers before funding a project. The Gates Foundation has also recently funded a self-regulating approach by the drug industry called the Access to Medicines Index. But publicly, the Seattle philanthropy declines to say much about this burgeoning dilemma in global health.

“The Gates Foundation is incredibly influential when it comes to global health policy and, frankly, it seems outrageous that they won’t speak out publicly on this issue,” Love said. The philanthropy works closely with the drug industry, claims all lives are of equal value and it has made addressing ‘market failures’ in global health one of its primary missions, he said.

The rise of the generics drug industry represents one of the greatest success stories in global health, Love said, a market-based solution to addressing the needs of the poor that is now under threat.

Herrling, who though he represents Novartis is widely credited by many activists like Love with genuinely seeking to resolve this dilemma, said his company has a “long-standing relationship” with the Gates Foundation that includes finding ways to improve access to medicines in poor countries.

Now that his former colleague Trevor Mundel is the head of global health, he said he expects that relationship to grow stronger.

“I’m sure we’ll be talking more about how to address this whole issue of access,” Herrling said.

Just not in public, probably.

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Tom Paulson

Tom Paulson is founder and lead journalist at Humanosphere. Prior to operating this online news site, he reported on science,  medicine, health policy, aid and development for the Seattle Post-Intelligencer. Contact him at tom-at-humanosphere.org, follow him on Twitter @tompaulson and/or send a comment below.

  • tferguson

    I notice this article makes no mention of the fact that the glivec patent at issue is a patent on a particular salt (the mesylate salt), rather than on the drug itself. the mesylate is not part of the drug, nor is it a novel molecule, it is used specifically to provide some marginal enhancement in uptake or perhaps effectiveness. if someone brought to market a potassium salt of naproxen (typically sodium is used for this), a US court would certainly not grant a patent on it as a new drug. with this decision, India has simply said that they won’t either.

    • http://humanosphere.kplu.org Tom Paulson

      Yes,
      Good point. I believe Novartis’ position is that because the mesylate salt form of Glivec significantly increased bioavailability (by 30 percent, I think is what Herrling told me) it should be considered a new compound.