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Thoughts on the Gleevec Controversy

We have borne in mind the object which the Amending Act wanted to achieve, namely…to provide easy access to the citizens of this country to live saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.

With these words a Division Bench of the Madras High Court dismissed the petitions filed by multinational drug company Novartis against a key provision of the Indian Patents Act, 1970. The provision in question, called section 3(d) seeks to promote public access to affordable drugs by restricting the granting of frivolous patents on medicines.

Before I dive into the fascinating story of the politics behind public health let me briefly give a backgrounder to the ‘Gleevec issue’.

Gleevec is a drug used to treat a form of cancer called chronic myeloid leukemia. The drug was invented by the Swiss multinational drug company Novartis which has a patent for it. However, the Indian Patents Act of 1970 has provisions that grant ‘process patents’ and not ‘product patents’ (I shall explain the legalese later in this text). What this basically means is that companies could only obtain a patent for the process of manufacture and not on the final product itself. This enabled Indian pharmaceutical companies to reverse engineer the final products and discover new processes to manufacture them, thus giving rise to the generic industry. What this meant in practical terms is that India – thanks to domestic pharma companies that made generic versions of many of the multinational companies’ drugs – went from a net importer of drugs to a net exporter. By the same token, drugs which were overall expensive post-independence became cheap by the 1980s. In fact, global NGO’s working in the field of public health procure affordable drugs from India to use them in Africa, Asia and Latin America.

However, as a member of the WTO and a co-signatory of the TRIPS agreement India had to bring her domestic laws in compliance with international laws. It is in this context that the Gleevec controversy has to be examined.

It is an indictment of our media and society that important issues are given short shrift in favour of fluff and floss. The gleevec issue barely got a passing mention in the mainstream media.

And now we dive headlong into the chemical sludge…

In May 2006 Novartis AG and its Indian subsidiary, Novartis India (henceforth Novartis) filed a bunch of writ petitions before the Madras High Court claiming that section 3(d) of the Indian Patents Act was contrary to the requirements of the TRIPS agreement and article 14 of the Indian constitution as it is vague and ambiguous. But what is section 3(d) about?

In a nutshell, 3(d) aims to prevent the practice called ‘evergreening’ by which drug companies seek to extend monopoly on their drugs by patenting minor variations of that chemical entity. Suppose a drug company has a patent on a chemical entity that is about to expire. What they will do is tweak the drug slightly and patent the new product(s). This guarantees that generics cannot be manufactured and that the patent is extended by another 20 years.

Section 3(d) was introduced into the 1970 Patents Act (the bedrock of Indian patents law and a progressive piece of legislation) via the Patents Amendment Act of 2005. This was done to meet India’s WTO obligations to grant product patents. Now, the 1970s Act granted only ‘process patents’ to agricultural and pharmaceutical products. Only the manufacturing process could be patented for 7 years and not the end product.

India’s WTO obligations meant that product patents would have to be granted. Since India signed the WTO agreement in 1995 she was given 10 years to bring her domestic laws in compliance with WTO requirements. But the TRIPS agreement also permits certain flexibilities. It was in this backdrop that section 3(d) was woven into the Patents Act via the amendment.

What 3(d) says is : The mere discovery of a known substance which does not result in the enhancement of the known efficacy of the substance would not be considered an invention under the act.

Translation: salts, esters, ethers, polymers, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy (emphasis mine).

There are other safeguards provided in the 2005 Amendment, but I will not get into these now.

Gleevec is the crystalline form of the Mesylate form of Imatinib, a molecule discovered in 1992. It was a revolutionary breakthrough in anti-leukemia treatment. In 2002 Novartis started marketing Gleevec in India and also applied for an EMR. At the same time Indian companies were selling generic versions of Gleevec for a tenth the price Novartis was charging. Consider these figures: Novartis charged Rs 1,20,000 per patient per month while Indian companies were charging between Rs 8,000 to 12,000.

Novartis was granted an EMR on the basis of its patent for Gleevec in Australia. Based on this Novartis dragged some Indian pharma companies to court for selling Gleevec generics. The Madras HC restrained 7 companies. This impacted the procurement of low cost alternatives of Gleevec for cancer patients in India and around the world. In India alone 25,000 people are diagnosed with CML every year.

Several organizations opposed the granting of EMR for Gleevec as a result of which the Chennai patent office denied a patent on Gleevec to Novartis. In May 2006 Novartis filed a petition in the Chennai High Court against the patent office’s decision on the grounds that

• This was not TRIPS compliant
• It violated the equality provision of the constitution
• The terms ‘efficacious’ as used in 3(d) is vague and ambiguous. What does it mean and who defines it. How much more efficacious should a new entity be?

On August 6, 2007 the Chennai High Court dismissed Novartis’ petitions on all counts. The judgement stated that an Indian court wasn’t the proper forum to arbitrate on whether domestic law was in compliance with TRIPS.

Hold the victory celebrations. There are some questions to consider. How does the ‘Gleevec issue’ impact public health and access to cheap and affordable medicines? It is disturbing that not only does India not have a publicly funded universal healthcare system, but also spends less than 1 percent of GDP on health. And in a time of general retreat by the state from essential public services can we afford a ‘let the markets decide’ logic prevail in the health care sector, particularly in a country like India where 25 percent of the population lives below the poverty line?

Paradoxically, medical tourism is the latest buzzword for ‘India shining’. Tourists from abroad come to India to avail of world-class medical facilities in private hospitals at an ‘affordable price’ which is nevertheless out of reach for the average Indian. And poor Indians go to rundown government hospitals where they contract additional diseases by the time they finish filling out forms in triplicate.

Moreover, how do we negotiate the complex regime of intellectual property rights and the legal shields meant to enforce them while at the same time providing a modicum of succor to the people whom it excludes? At the same time evolving a system of intellectual property rights that protects indigenous as well as locally developed knowledge from bio-piracy.

Note: I want to thank Julie George at the Lawyers Collective for her time and excellent paper ‘How the Patent Regime endangers people’s access to medicines’ for insights as also Chan Parks’ cover story in the LC newsletter. Most of the material here is borrowed from these sources.

5 responses to “Thoughts on the Gleevec Controversy”

  1. JD says:

    Good article, thank your for taking the time.

    Jon
    US

  2. Tushar says:

    Thanks. It was a real pleasure working on it.

  3. mbra says:

    Wow. It’s amazing how asymmetrical information can destroy people’s lives. I’ve been on the dole for four years now just so I can keep gleevec (in California) and others pay such a huge cost they lose their homes. I look forward to seeing how the Indian generic controversy eventually effects US healthcare policy. Thanks for the article!

  4. Anish John says:

    Dear Frnd,
    My self is anish john.. m a social work graduate, settled in coimbatore, tamil nadu… the article is very informative.. and got info abt this artilce from my friend.. i would like to get more info abt this..

    best wishes

    + Anish

  5. […] problem with Gleevec, whose generic name is imatinib, is its price, which led an Indian court to invalidate its patent in 2008. Medpedia downplays the controversy, and on this subject at least Wikipedia does a better […]

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