Sun loses US patent case for lucrative drug

Sun Pharmaceutical Industries has lost a patent infringement case in the US on Cardene, a drug for controlling high blood pressure. However, the main patent expires this November.

The company had made $181 million in sales of the generic equivalent of Cardene in the US for the 12 months ended June 2008, according to the IMS data. That will have to stop till at least November. A US district court ruled last week that Sun Pharma’s generic equivalent of Cardene injections infringes on the patent rights of EKR Therapeutics Inc and PDL Biopharma.

The development may impact for a while Sun Pharma’s plan to expand into injectable generics, a segment in which value erosion is less during the run-up to patent expiry in the US market, due to less competition. Israeli drug major Teva has been marketing its own generic version of Cardene injections since September 2008, for which there is no legal challenege. After Teva’s launch, the price had eroded by only 20 per cent, and this could have been a good money spinner for Sun Pharma this year, said analysts.

“Generally we avoid making any statements or announcements about our product pipeline, specially Para IV products, till these are approved. Even in this case, it would be difficult for us to respond on the litigation, and our going forward strategy,” said a Sun Pharma spokesperson.

The drug originally belonged to Roche and was licensed out to PDL BioPharma, which sold the rights to EKR Therapeutics in February this year. PDL BioPharma sued Sun Pharma in April 2007 for infringing the main US Patent on Cardene. Judge Katharine S Hayden ruled that Sun Pharma’s generic infringed the patent, as it is similar to the patented Cardene.

Now Sun Pharma has the option of appealing in the state Supreme Court against the decision, but it seems unlikely, as the patent nears expiry, said an expert.