Pharma giant loses legal battle

Pharma giant loses legal battle


While the media has been busy and preoccupied with reporting about the global problem of Swine flu, many of them really missed an important news item. This is with regard to multinational drug major Novartis losing its legal battle in India and a real victory for the people.

Novartis is a Switzerland-based drug manufacturing company. It’s a pharma giant operating in 140 countries with a net sale of $ 41.5 billion for the year 2008. But in spite of being rich and powerful it lost a battle which lasted for over three years.

Novartis had applied for a drug patent at India Patent Office and the same was rejected by the office. Here are the details of the battle: A patent is a set of exclusive rights granted by a state to an inventor or his assignee for a limited period of time in exchange for a disclosure of an invention or innovation. In April 2005, India’s parliament amended the Indian Patents Act 1970; medicines could now be product-patented and also for a period of 20 years in India (whereas it was earlier only for seven years).

However, Section 3(d) of the amended Act specifies that new forms of known substances do not deserve patents. Section 3(d) is a unique provision, which states that “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance....unless such known process results in a new product or employs at least one new reactant.”

 In simple words it means that Section 3(d) does not allow frivolous or incremental patents or ever greening of patents and restricts it to patents that are genuine discoveries. This particular legal frame work has attracted global attention and many countries are eagerly looking forward to incorporate it in their own patent laws.

The drug that Novartis had sought patent for was Glivac (imatinib mesylate) -- a useful medicine to treat a variety of blood cancer. This drug needs to be taken life long and it not only increases longevity but also improves the quality of life.

Treatment with Glivec, the one manufactured and marketed by Novartis, costs Rs 1.2 lakh a month, whereas Indian companies, nine of them, are making and marketing it at a price of about Rs 8,000 to Rs 9,000 per month. It actually costs about Rs 1,000 or less, so it is obvious that Indian companies too are deriving high profit margins, though much less than Novartis.

If patents had been granted to Glivec then it would have been out of reach for nearly everyone in India as Indian companies cannot produce the drug. Glivec is a classic illustration of how a patentenable drug monopoly can be and is harmful to the majority but good for the company's huge profits. Novartis sold globally in 2006 $ 2.6 billion worth of Glivec.

Good precedent set

The real issue at stake is not about a single drug (in this case Glivec) that gets patented or not but if patents had been granted then it would have let lose a flood of such frivolous patents applications. Thus the Glivec issue would have set a bad precedent. This would have had an extremely deleterious effect on access to medicines to several people not only in India but all over the world, as India exports drugs to around 200 countries.

But all is not well. There was news recently highlighting the release of a US business funded study on India’s patent law at the US - India Business Council (USIBC) summit. The study reportedly mentions that Section 3(d) of India’s Patents Act, “prevents” incremental pharmaceutical innovations from receiving patent protection, “inhibits development of safer, more efficacious and more useful drugs for Indian patients.”

This is not a new allegation made by US based pharmaceutical industry and its backers and neither is it true. The Union minister of commerce and industry Anand Sharma will shortly be participating in a meeting being organised by USIBC and it will be interesting to see his reaction.

While introducing Section 3(d) the parliament recognised public health concerns regarding ‘ever greening’ - a common practice of pharmaceutical companies to extend their patent monopolies on known medicines by making insignificant or minor changes.
 This provision acts as a check on pharmaceutical companies obtaining patent monopolies for medicines that are not actual inventions, such as combinations or slightly modified formulation of existing medicines. So we need to get proactively involved to keep our laws safe. Eternal vigilance is the only remedy and answer to the onslaught from the big companies.

(The writer is co-convener, All India Drug Action Network)

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