21 June, 2007

Ranbaxy loses US apex court appeal in Lipitor case

Buisness Line
Business Daily from THE HINDU group of publicationsWednesday, Apr 04, 2007

Mumbai April 3 With sales grossing $12.9 billion on Pfizer's cholestrol drug Lipitor, the path to get a slice of that market was always known to be riddled with law suits for generic challenger Ranbaxy.
But the litigation-filled pathway crossed a major milestone on Monday, when the US Supreme Court declined to intervene in Ranbaxy's appeal of a lower-court ruling given last year upholding a Pfizer patent on Lipitor. And this has possibly signalled the end of hi-decibel litigation on Lipitor or generic atorvastatin, say pharma-analysts.
Industry officials familiar with the development point out that Ranbaxy may still have something to cheer.
In August last year, the US Court of Appeals for the Federal Circuit had upheld Pfizer's main patent on atorvastatin (US Patent No 4,681,893) whose patent expires in March 2010, while invalidating another (US Patent No 5,273,995) whose patent-life was to expire in June 2011.
Ranbaxy can look to advance its launch on the second patent to 2010, the industry representative said. In fact, last year Ranbaxy's chief Mr Malvinder Singh had indicated just that. The court decision had shorn 15 months off the patent (`995) and Ranbaxy was working towards bringing the launch date forward, with a 180-day exclusivity in the US market, he had told Business Line.
But with Pfizer claiming that the second patent had been invalidated on technical grounds, and with Pfizer applying to the US Patent and Trademark Office for a valid patent to be reissued (on `995), analysts are keeping a keen eye on developments here.
Ranbaxy has been locked in battle with Pfizer over Lipitor since 2003, when the Indian drug-maker was hauled to court by the multinational drug company for alleged patent infringement on its cholestrol drug. Subsequently, the two companies have battled for Lipitor in 17 different markets, including the US, the UK and Canada and with varying fortunes.
But analysts and investors keenly watched developments in the US market, as it brought the best prices on the drug.
Litigation expenses
Litigation expenses have been factored in and the outcome on the case has been along expected lines, said one analyst. This sentiment was reflected in Ranbaxy's share price that closed marginally up, at Rs 343.80 on Tuesday.
It, however, had fallen on Monday, by about three per cent, fuelled by market-talk that the court would act in Pfizer's favour. And with the court ruling this week in the US giving Pfizer a booster shot, much of the action is pretty much over, an analyst said.
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