Novartis: India rejects patent plea for cancer drug Glivec

Activists demonstrate against Novartis in New Delhi - July 2012 Many poorer people rely on India's generic drug industry

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India's Supreme Court has rejected a plea by Novartis to patent an updated version of its cancer drug, Glivec.

The Swiss drugmaker had been denied a patent by Indian authorities on the grounds that the new version was only slightly different from the old.

The decision means generic drugmakers can continue to sell copies of the drug at a lower price in India, one of the fastest growing pharmaceutical markets.

Novartis said the decision "discourages future innovation in India".

"This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options," said Ranjit Shahani, vice-chairman and managing director of Novartis India.

Glivec, which is used to treat chronic myeloid leukaemia and other cancers, costs about $2,600 (£1,710) a month.

The generic equivalent is currently available in India for just $175.

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Some 40% of the drugs produced by India's $11bn pharmaceutical industry are exported”

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There were concerns that, if granted, a patent could threaten access to cheap generic versions of life-saving drugs in poorer countries.

"This will go a long way in providing affordable medicine for the poor," said Anand Grover, a lawyer representing Cancer Patients Aid Association, adding that he was "ecstatic with the ruling".

Long battle

Novartis applied for a patent in 2006 for its new version of the drug, arguing that it was easier to absorb and therefore qualified for a fresh patent.

However, the Indian patent authority rejected the application based on a law aimed at preventing companies from getting fresh patents by making only minor changes to existing drugs, a practice known as "evergreening".

Officials also turned down a subsequent appeal by the company three years later.


There were celebrations outside the Supreme Court as the landmark decision was read out. One charity, Doctors Without Borders, called it a victory for poor patients not just in India but across the world.

The bone of contention was Section 3D of India's patent laws and the court argued that Novartis had to demonstrate that Glivec represented more than just a small improvement to an existing substance. In its ruling, the court said it wanted to discourage "repetitive patenting".

The decision is seen as a major boost for generic drugmakers in India who supply cheap medicines to poor people across the developing world.

India exports generic drugs worth $11bn (£7.23bn), including crucial anti-retrovirals supplied to Africa.

Experts say Monday's court order will set a precedent for the so-called "patent cliff" - a phrase used to describe the expiry of pharmaceutical patents across a range of blockbuster drugs.

It is estimated that drugs with combined annual sales of $150bn will go off-patent by 2015 and that could help companies here earn millions of dollars in profits.

On Monday, India's Supreme court rejected the firm's appeal to get patent protection for the drug.

The AFP news agency quoted the court as saying that the updated drug "did not satisfy the test of novelty or inventiveness" as required by the law.

Setting a precedent?

Patents usually protect the companies for 20 years of exclusive sales. After that, it is open to other firms who can make cheaper copies of the original drug.

Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days.

After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop.

It is estimated that drugs with combined annual sales of $150bn will go off-patent by 2015.

India's generic drug makers are among the biggest in the world and many expect them to benefit from these patents expiring in the coming years.

However, there have been concerns that if firms are granted patents for updated versions of their drugs, it may not only deny access to cheaper medicines to poor people, but also hurt the makers of generic drugs.

Pratibha Singh, a lawyer for the Indian generic drug manufacturer Cipla, said the ruling had set a precedent that would prevent international pharmaceutical companies from obtaining fresh patents in India on updated versions of existing drugs.

"Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug,'' she said.

Shares of Novartis India fell almost 5% on the Bombay Stock Exchange, while stocks of generic drugmakers such as Cipla and Natco rose after the judgement.


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  • rate this

    Comment number 93.

    Indeed! That's a lot of trouble to fix, but I think that if more standardised generic drugs are multisourced by good firms, not only does trust grow, but those involved will be less likely to want to be seen as failing a system that gives them new advantage.

    Even the most hardbitten 'neoliberal' should understand that the higher the stakes, the more competitors may be inclined to fight dirty.

  • rate this

    Comment number 92.

    Thanks Crow (89).
    It's a relief considering the fact that India is already a global hub for dirty clinical trials ( ), human organ trade, massive misuse of antibiotics (by doctors & self medication), highest environmental pollution by pharma industry ( ) etc.

  • rate this

    Comment number 91.

    For 34, and 68:
    Trial costs may be reduced in nationalised context. With *honest* informed consent, patients may choose risky treatment if nothing else works. Of course, this means that finding patients must be easy too. Not possible in privatised subgroups of a fractured NHS: "Oh no, can't have one of ours, patient confidentiality, don't you know..." Only honest co-operation can lower the costs.

  • rate this

    Comment number 90.

    From 31. gerald:
    "Can someone/anyone from the large Pharmaceutical companies
    please tell us ALL what their profit margins are?"

    No answer, came the stern reply. :)

    If it were nationalised, you could get stats with a 'Freedom Of Information' request. Even our bad UK govt has made that much possible, even while it undermines it all at the same time. Such chaos, so little vision and courage!

  • rate this

    Comment number 89.

    From 86. Jay:
    "Will iPhone5 be allowed patent protection or should it be considered 'minor changes' to existing product (iPhone4)? Similar Qs arises for other products in consumer electronics, automobile etc."

    Doesn't work that way, not exactly... Specific models would be protected by copyright and trademark law, not patents. New patents would only relate to signifficant internal innovations.


Comments 5 of 93


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