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Patent pangs and sales sclerosis

... The setbacks could force a rethink over the strategy to force open the door to lucrative markets like the US through patent challenges that are made through Para IV ANDA applications.

In a Para IV application, the applicant who intends to make the generic version of a drug believes that the patent (of the innovator) is not infringed or it is invalid.

The truth is that generic drug manufacturing companies have had a poor run since 2004 in major litigation challenging patents in international courts.

Nevertheless, Indian pharmaceutical makers are still looking for other ways to make their presence felt on the world markets.

Analysts tracking the developments in the industry said that out-of-court settlements and market exclusivity agreements — similar to the one inked by Ranbaxy and Cephalon Inc on narcolepsy drug Provigil — could well turn out to be the favoured road as generic drug manufacturers seek to get a foothold in global markets.

Pharma makers have also been buying boutique drug outfits in the US and other countries.

Nicholas Piramal for instance acquired British pharma major Avecia for £9.5 billion.

Ranbaxy Laboratories has sought to establish firm foothold in Asia, particularly in Japan.

Around the same time, Dr Reddy's Laboratories Ltd inked a deal to acquire Swiss pharma company Roche's facility manufacturing active pharmaceutical ingredien...

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