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P. T. Jyothi Datta

Mumbai , Sept. 12

IT is the mother of all patent challenges, quips an analyst closely watching the development of Ranbaxy's onslaught on Pfizer's $12-billion cholesterol drug Lipitor.

Whether or not success is scripted in favour of Ranbaxy, the case is becoming a touchstone of sorts for the generic drugs industry, says the analyst.

A court in the UK is expected to give its ruling this month on the issue. And there is more at stake than just the money, observes a representative with the Indian drug industry. The image of the company and the morale of the industry also hang delicately in the balance, he added.

With Lipitor, the challenge is on the world's largest drug company's money-spinning blockbuster. Ranbaxy has challenged Pfizer's atorvastatin, sold under the Lipitor brand name in different markets, including the US, the UK and Austria. The Austrian lower court has ruled in favour of Ranbaxy and Pfizer has gone in appeal.

The ruling from the UK court will not have a bearing on the proceedings in the US court, which is expected to give its ruling by the year-end. Pfizer has multiple patents on the drug, staving off generics up to 2010, observes another analyst, explaining the contours of the case.

"We believe we have a strong case. More than that, we cannot comment as the matter is sub-judice," a Ranbaxy spokesperson told Business Line.

The generic drugs industry, often called none-too-generously as the copy-cat medicines business, has often locked-horns with patent-driven or innovator drug companies. But when a litigation is resolved by the court, it is a shot in the arm not just for the company winning the case, but also the segment of industry (generic or innovator) it belongs to, observes a representative with the Indian drug industry. The image and morale are also linked to the huge litigation cost and revenues, he explained.

Ranbaxy and Dr Reddy's Laboratories (DRL) are among the clutch of Indian generic drug companies that have walked the path of challenging patents in other markets. In another high-profile case last year, DRL was restrained from selling its version of Pfizer's hypertension drug amlodipine maleate in the US. The drug has an estimated market size of $2 billion in the US.

Among other significant litigations, Ranbaxy had also fought a long legal battle for the US market to launch the generic cefuroxime axetil sold under the brandname Ceftin by the innovator-company GlaxoSmithKline, recollects an analyst. But Cefuroxime is an estimated $400-million market compared to the blockbuster that is being taken on now.

As more generic players eye the atorvastatin market and innovators bring in second-generation statins, the stakes will only get bigger, observes the analyst.

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