PHM-Exch> Pharma giant loses legal battle: India

[Claudio Schuftan]

>
> http://www.deccanherald.com/content/12593/pharma-giant-loses-legal-battle.html
> DECCAN HERALD, Thursday 9th July 2009
>
> *Pharma giant loses legal battle*
>
> By Dr Gopal Dabade
>
> *The drug that Novartis had sought patent for was Glivac, a medicine to
> treat a variety of blood cancer.*
>
> 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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