Business

If India can stand up to Big Pharma, so can SA

By Simon Allison 3 April 2013

In South Africa, we make it really easy for pharmaceutical giants to endlessly extend their medical patents – and, consequently, their lucrative monopoly on certain life-saving drugs which could be hundreds of times cheaper. India’s landmark judgment against Novartis shows that there is another way. By SIMON ALLISON.

In the pharmaceutical industry, profits are indistinguishable from patents (not patients, although your confusion is understandable). The longer your patent lasts, the longer you have a monopoly on the sale of a particular drug – and monopolies, as any greedy corporation knows, are good for business. The key to the really big money, therefore, is to extend the lifespan of your patents even further than the typical 20 years that international law provides.

To do this, pharmaceuticals employ a practise known as “evergreening” – a deceptively innocuous name. The idea (in its simplified form) is that you make minor tweaks to the makeup of an existing drug which could then qualify for a whole new patent, and another two decades of protection from generic competition.

In the United States, with its notoriously trigger-happy patent office, this works. In South Africa, with our obsolete depository patent system (no one actually checks the patent unless it is challenged in court), this also works. In India, however, it doesn’t, as the country’s top court affirmed in a landmark ruling this week.

Concluding a seven-year legal battle between the state and pharmaceutical giant Novartis, India’s supreme court ruled that making small modifications to an existing drug is not enough to qualify it for a new patent. It also concluded that, under international law, India has solid grounds on which to make this determination.

The law in question – the Trade-Related Aspects of Intellectual Property Rights, or Trips, to which India is a signatory – allows for certain “flexibilities” for countries when implementing intellectual property protection. These are designed to help less-developed countries pursue public policies. By taking advantage of these flexibilities, India has guaranteed that anti-cancer drug Glivec (the subject of the lawsuit) will remain available as a generic to Indian patients at a cost of around $73 a month, as opposed to $4,000.

Novartis, which makes Glivec, is not happy. “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options,” said Novartis India MD Ranjit Shahani, making the familiar argument that lax intellectual property regimes (and therefore the inability to guarantee gargantuan profits) will stifle research and development into new, potentially life-saving drugs.

That’s not strictly accurate, said Marcus Low, a researcher with the Treatment Action Campaign who specialises in patent law. “Novartis is saying the ruling will make it harder to invest in new research and development. People just take that at face value. But what happened here is that a patent for a relatively small change was rejected on an existing medicine.” This, Low argues – and it’s hard to disagree – is not real research or innovation. “We would argue that requiring true innovation for a patent would actually incentivise companies to invest in real innovation.”

Real pharmaceutical breakthroughs, in other words, deserve the patents they get and the profits that then accrue. Evergreening, however, is not real research; it’s an (often successful) attempt to manipulate international law.

If you don’t believe me, then listen to Brian Druker, director of the Knight Cancer Institute and the man who invented the active molecule in Glivec, the drug that was the subject of the Indian judgment. “Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments,” he said. “But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.”

All of which brings us to South Africa, and the big question: if India can utilise the flexibilities in Trips to bring affordable anti-cancer drugs to its citizens, why can’t we?

As it currently stands, Novartis holds a 20-year patent in this country on imatinib, the molecule created by Druker which forms the basis of Glivec. This patent will expire in April 2013 – this month – but Novartis has already taken out a new patent for imatinib mesylate salt, a minor modification of the drug which would give it another 20 years of patent protection. This is similar to the modification which India’s supreme court found to be too minor to warrant a new patent.

To give you some idea of what this means in practise, Médecins Sans Frontières claims that treating a single patient for a year in South Africa with the patented Novartis drug costs $33,896, which is an astonishing, horrifying 259 times more expensive than the cheapest Indian generic equivalent.

Sure, Novartis has apparently set up a donation programme to help public-sector patients in need of the drug, but the scale of the programme remains a mystery (the company didn’t answer any of the questions put to it by the Daily Maverick) [UPDATE: In an email to the Daily Maverick, Novartis said they did not believe that the Indian case would have any impact in South Africa. No reasons were given]. The reality is that for most public-sector patients, access to Glivec at current prices is pretty much impossible.

For the most part, our antiquated patent laws are to blame. Take this from the Mail & Guardian last month: “Two thousand four hundred and forty-two. That’s the number of medicine patents South Africa granted in 2008. In Brazil, only 273 patents were given between 2003 and 2008. South Africa grants patents without substantially reviewing applications first and routinely gives patents for new versions of old medicine, thus in effect extending patent life beyond the normal 20-year period. Brazil, in contrast, examines each application before a patent is granted.”

It’s a bit of mess, and very easy for sophisticated corporations to abuse. The good news is that our patent laws are currently under review by the Department of Trade and Industry, which should be paying close attention to what’s happening in India. The bad news is that the department is not sharing what its new policies will look like, and it is not consulting civil society groups, such as Treatment Action Campaign, Section 27 and Médecins Sans Frontières, which have taken a strong interest in the issue.

India has shown that developing countries can stand up to the big pharmaceutical companies – and win. There’s no reason why South Africa – where Novartis has already enjoyed a 20-year monopoly on its anti-cancer drug – cannot follow suit. DM

Read more:

  • A ‘shocking’ disregard for generics in the Mail & Guardian
  • The Novartis decision: Is the big win for Indian Pharma bad news for investment? on Time
  • Novartis patent ruling a victory in battle for affordable medicines on the Guardian

Photo: A man buys cancer drug Glivec for a relative who is suffering from cancer at a pharmacy in a government-run hospital in the western Indian city of Ahmedabad April 2, 2013. India’s top court dismissed Swiss drugmaker Novartis AG’s attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics. REUTERS/Amit Dave

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