The Hindu Business Line : Patent battle with J&J — A legal win for Sun Pharma in US generic drug market

Corporate - Corporate Disputes
Industry & Economy - Pharmaceuticals

Patent battle with J&J — A legal win for Sun Pharma in US generic drug market

P. T. Jyothi Datta

"The United States District Court for the Eastern District of Michigan granted Caraco's motion for non-infringement on its generic version of Ultracet."

Mumbai , Oct. 25

AWAY from the glare that a patent-challenge brings, Sun Pharma scored its first victory of sorts in the US generic drugs market.

Sun Pharma's subsidiary Caraco received a favourable ruling last week from a US court regarding plans to launch the generic version of Ultracet, a painkiller drug from Johnson and Johnson (J&J).

The case could go into appeal, but an analyst tracking the issue expected Sun's Caraco to launch generic Ultracet in the US, once it gets regulatory approval. The sales of Ultracet are about $330 million. Generic Ultracet would generate about $20-25 million for Sun (Caraco) within 12 months of launch, the analyst said.

Caraco's generic Ultracet will be the third such drug in the market. Generic versions of the drug from Par Pharmaceuticals and Ivax were launched in the US this year, even as the former awaits the court's decision on a similar case.

Sun Pharma holds a 72 per cent equity in the Detroit-based Caraco Pharmaceutical Laboratories Ltd. The favourable initial ruling for Sun's Caraco comes close on the heels of an unfavourable ruling on a patent-challenge that another Indian company, Ranbaxy, received, albeit from a UK court .A note from Caraco said, "The United States District Court for the Eastern District of Michigan granted Caraco's motion for non-infringement on its generic version of Ultracet." (J&J's Ortho-McNeil unit has the right to appeal.)

J&J's Ortho-McNeil Pharmaceutical unit had approached the court to block approval of Caraco's application until the patent on the drug expires in August 2011.

According to agency reports, "U.S. District Judge George Caram Steeh in Detroit ruled Oct. 19 that Caraco's version of Ultracet doesn't infringe a Johnson & Johnson patent."

An approval from the US Food and Drug Administration (FDA) is pending for Caraco's version of Ultracet. Par Pharmaceutical launched its version of the drug in April 2005 without waiting for a Court ruling. Ivax, subsequently, launched an authorised generic through an agreement with J&J that allowed it to sell an unbranded version of Ultracet.

The favourable ruling gives high visibility in the US market to Caraco, seen otherwise as a marginal player, the analyst said.

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