Novartis drug ruling a victory for patients

Amrit Dhillon says ruling against Novartis over anti-cancer drug Glivec exposes the flaws in profit-focused business models and also patent laws

PUBLISHED : Thursday, 04 April, 2013, 12:00am
UPDATED : Thursday, 04 April, 2013, 3:17am

Rightly seen as the outcome of a battle between "patients and profits", the Indian Supreme Court's ruling on Monday against Novartis' demand for a patent for its leukaemia drug Glivec has been hailed as a victory for cancer patients.

India is the first country to deny the Swiss drug giant a patent for Glivec. The effect of the ruling will be felt not just in India but in other developing countries, where leukaemia patients who need the medication will now be able to obtain a generic version for a fraction of the price of the branded one.

Novartis wanted a patent on its new version of Glivec. Had it received it, the company would have enjoyed another 20-year monopoly on the medication. But for a patent to be granted, India has decided that the drug in question must be a significant improvement on earlier ones.

In this case, the Supreme Court decided that simply tweaking the formula cannot justify Novartis' plea for a new patent. Health activists claim that Western drug companies are claiming patents for drugs that are neither breakthroughs nor really innovative but simply minor alterations.

For millions of cancer patients in India, it is regarded as a wonderful ruling because it attacks "evergreening", the term used to describe the way firms amend an existing process or product to seek a fresh patent once the original intellectual property protection expires.

There are currently several other cases in the Indian courts involving big names such as Pfizer and Roche that are demanding a patent. India's generic drug manufacturers argue against a patent so that they are free to manufacture cheaper versions.

Some of the drugs are so expensive - about US$2,600 a month for Glivec - that only the rich in India can afford them.

In its defence, Novartis has said that the firm provides Glivec free of charge for nine out of 10 leukaemia patients in India. That may be true, but the point is that Indian patients should not be dependent on charity. They want an affordable drug.

Everyone understands the need for drug companies to invest in research. Their years of effort and expense need to be rewarded. But surely they should feel embarrassed at demanding patents for drugs which they have just fiddled with?

The number of real blockbuster drugs is very limited. If India's ruling forces these firms to aim for genuine breakthroughs, it might end up doing the industry - and people's health - a lot of good.

The ruling has also exposed the need to re-examine the patent system so that a minor tweak to a formulation is indeed rewarded, but in a way that is commensurate with its originality. It could be argued that a modification that makes a drug less toxic, for example, or reduces the required dosage, is of great value. If that's the case, then we need to assess these innovations appropriately.

At the moment, we have an "either-or" system where a company either gets a patent giving it a 20-year monopoly or nothing at all.

These are grey areas that need to be aired, if only the drug companies could accept that an industry dealing with human suffering and saving lives cannot be treated in the same profit-driven manner as making fridges or chocolate.

Amrit Dhillon is a freelance writer in India