GLIVEC PATENT APPEAL OF NOVARTIS REJECTED: A GLOBAL REPRIEVE

It was a big concern and came as a big relief.

It was about social concerns Vs commercial interests and in a world where over a billion people live in absolute poverty ($1.25 a day) while another billion plus people do not have a comfortable living (between $1.25 to $2 a day), it was a needed reprieve.

It was a court battle in an Indian court that the whole world was watching, from governments, to corporations, to activists, to people, calculating the aftermath of the outcome from their perspectives.

And the way Novartis reacted on Supreme Court of India rejecting its Glivec (www.glivec.com) patent appeal tells us about the scale of the stakes. Reportedly, the Swiss pharma major has said that it would be more cautious about investing in India in future.

But the SC decision is not about India only. It is for the billions across the countries who cannot afford healthcare cost.

According to a report*, in 2008, 54 per cent of the new cancer cases were from African and Asian countries while the region accounted for 61 per cent of the cancer deaths. It is just a natural corollary when such reports point out that the less developed regions account for greater number of new cases and deaths because majority there cannot afford the treatment available.

A report** on HIV/AIDS prevalence says, in 2010, around 30 million of the 34 million adults and children living with HIV/AIDS were from African, Asian and Latin American countries. Sub-Saharan Africa alone accounted for almost 23 million cases. Naturally, these regions have world’s poorest countries with no or very poor health infrastructure.

The predominating stand on healthcare in context of these concerns has to be socially oriented. Here, the social concerns have to prevail over the commercial interests when there are billions not able to afford the treatment costs resulting in death of millions annually.

The SC’s Glivec decision has to be seen in this context only.

In case of life threatening diseases like Cancer or HIV/AIDS, the cost of the diagnosis as well as of the medicine is out of reach of almost of the population segments living in the poor countries.

Pharma giants claim they develop such medicines after pumping billions of dollars in R&D. Many of such medicines, known as blockbuster drugs (generating revenue of a billion dollar or more a year) are priced astronomically high in order to recover the costs.

Initially justified, soon the break-even point and the ethical business of profit-making give way to a monopolized profiteering exploiting the legal tools like the exclusivity patent or the extended patent once the exclusivity patent expires. In some cases, it is genuine. In most of the cases, it is intended to manipulate, a practice known as ‘evergreening’ where the manufacturer goes for the minimum possible modification in the drug so as to meet the patent extension criteria.

In the Glivec case, the SC didn’t find Novartis’ claim of further changes in Glivec innovative enough to grant it patent.

Novartis markets the drug Imatinib under trade names Glivec and Gleevec (US). Some other trade names for the drug are Glivic and Milatus.

Glivec is an anticancer blockbuster drug generating billions of dollars of revenue annually. Developed in 90s and hailed as ‘magic bullet’ in cancer treatment by the TIME magazine in 2001, Gleevec had a worldwide sale of $3.9 billion in 2009. Though it is not sure if the figure is for overall Imatinib sale but it tells Novartis has reaped enough of the profit from this blockbuster molecule alone.

And when it’s such an important medicine (some say it is miraculous in effects on some forms of Leukemia), it is to be seen and regulated that it reaches as far as possible, to the cancer patients who cannot afford it.

The ways out are to make the medicines available free as happened in case of Tuberculosis or to make the treatment available at affordable cost. Now, the profiteering Big Pharma cannot be expected to play such a role.

Tuberculosis was successfully routed out after the multi-drug therapy was made available free of cost at a mass level. HIV/AIDS spread has seen some significant control after the affordable antiretroviral treatment has been made available in poorer countries where maximum number of the affected live.

At a time, when governments and global bodies like the UN are finding it hard to fund free shipments of the antiretroviral medicines due to slowdown in the global economy, the generics have come as a big reprieve saving millions of lives. Cancer has no such provisions like the antiretroviral treatment on a worldwide scale and availability of the generic medicines is the most important ray of hope for the cancer patients who cannot afford the costly medicines of the big pharma companies.

So, the cost-barrier has to be brought down, either by making free shipments available or allowing other pharma companies to make the same medicines (generics) at fraction of prices, so that it can reach to the maximum number of the affected people.

And why not given the sensitivity of the price points involved. If we take the Indian examples where the country’s apex court has rejected the patent appeal of blockbuster drugs, it becomes clear.

Before Glivec, the SC had rejected Bayer’s patent appeal for its anti-cancer drug Nexavar that brought down the price, from Rs. 2,80,000 for Nexavar to Rs. 8,000 a month for its generic version. In case of Glivec, the cost of the generic version is around Rs. 10,000 a month while Glivec costs Rs. 1,20,000.

Given the high number of cases in low income segments, generics are the effective way to make the treatment available to a larger section of the global population.

The Glivec decision by the Supreme Court of India has once again given an opportunity to reiterate it. Even if the ruling comes as a short-lived reprieve as some analytical reports are pointing out as it would result reduced R&D and new medicines launches in India, it has to be appreciated for the fact that nothing is more important than saving human lives.

An analytical article in New York Times wrote on the development: “The ruling is a landmark in one of the most important economic battles of the 21st century, in which rich nations that increasingly rely on the creation of idea-based products like computer programs and medicines require poorer countries to pay for their ideas. But some countries – particularly India, Brazil and China – have begun to challenge the price they must pay, particularly when the ideas-based products are life-saving medicines that their people desperately need now.”

©/IPR: Santosh Chaubey – https://santoshchaubey.wordpress.com/

* http://www.cancerresearchuk.org/cancer-info/cancerstats/world/demographics/demographic-facts-for-the-world-population

** http://www.avert.org/worldstats.htm

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