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Week-in-Review Editorial: 18 to 24 August

India pays the price for Glivec patent rejection

The big story this week was Novartis' announcement that it would pull its R&D investments in India following an unfavourable decision by an Indian court in a patent protection case regarding the Swiss company's cancer drug, Glivec.

The Indian court dismissed the company's petition and referred it to World Trade Organisation (WTO) regulations which state that countries are allowed to order compulsory licenses which temporarily suspend patents and clear the way for generic drugs to protect public health in emergencies only.

Novartis' CEO, Daniel Vasella, stated in the Financial Times newspaper that Novartis would now withdraw "hundreds of millions of dollars in investment to expand research capabilities in the region."

Vasella insisted that the action was not a "punishment" but merely a reaction to a market that did not protect innovation and as such was "not an invitation to invest in Indian research and development, which we would have done.î He did not give any details of what his original investment plans in India were, but told the newspaper he would move them to another country where patents were protected.

Novartis' action, although financially sound, has attracted widespread condemnation from charitable groups, such as Medecins sans Frontiers, which say that the pharmaceutical industry is putting profits before patients. While the industry might save money in the long run, Novartis' move may further damage pharma's public image.

And what about innovation? In a world market where the number of new molecular entities (NMEs) up for regulatory approval has fallen dramatically, perhaps Novartis' argument rings a little hollow. Increased in- and out-licensing activities also suggest that pharmaceutical companies are trying to extend the lifecycles of their existing products rather than innovate.

On a softer note, not all pharmaceutical firms have been bearing their teeth this week. GlaxoSmithKline (GSK) gave consent through Canada's Access to Medicines Regime to enable local pharmaceutical firm Apotex to manufacture a generic fixed dose combination (FDC) antiretroviral (ARV), containing GSK's patented active ingredients zidovudine and lamivudine for the treatment of HIV/AIDS in Rwanda.

23rd August 2007

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