More pharma companies mull Para IV challenges

Posted AtThe Financial Express

It's not just Ranbaxy and Dr Reddy's Laboratories (DRL) who have decided to challenge blockbuster drugs from MNCs. In a significant move, it is learnt that five Indian pharma companies - Cipla, Wockhardt, Orchid, Matrix Labs and Aurobindo Pharma - are evaluating the option of Para IV filing of their abbreviated new drug application (ANDA) in the US and Europe. These companies are in talks with patent lawyers and consultants for Para IV filing, according to industry sources.These companies are targeting drugs valued at $300-$600 million and will go for para IV filing either alone, or jointly with other companies since the process is expensive, sources added. Sources also said that Cipla may tie up with one of its associates in the US for Para IV filing, since it may not want to directly come under the litigation procedures.

Once a patent challenge is successful, the challenger gets 180 days exclusivity period for sales of the generic drug, something that can dramatically improve the fortunes of Indian generic pharma companies. These legal battles, however, are unpredictable and risky. DRL had earlier won a legal battle against Eli Lilly, and enjoyed a six-month exclusivity for fluoxetine capsules, a generic version of Lilly's anti-depressant Prozac.

But it has suffered reverses since then. Ranbaxy, too, won a US case against GSK's Augmentin, which helped it generate revenues in excess of $100 million. But Ranbaxy recently lost a patent challenging Pfizer's Lipitor in the UK, after winning a similar suit in Austria.

While filing an ANDA, a generic company can choose Para IV as one of the four options. It can argue either the patent under challenge is not infringed or is invalid. Drugs worth $80 billion are going off patent in the US alone by 2010. The worldwide generic market is expected to touch $94 billion by 2009.

The development also signals the coming of age of several Indian pharma companies, other than Ranbaxy and DRL, in pharmaceutical litigation, which is assuming significance world over, owing to the debates over high drug prices charged by innovative companies and the issue of access to cheaper medicines in the wake of new and neglected diseases. Generic players allege that MNCs resort to evergreening of their patented drugs, thereby extending the life of patents. Some MNCs have also floated their own generic companies, thereby paving the way for authorised generics in the market.

October 24, 2005