India Rejects Patent Application for Abbott’s Kaletra

(Corrects type of protection sought in first paragraph of story published yesterday.)

Abbott Laboratories was refused patent protection on its AIDS drug Kaletra by India’s patent office, allowing Cipla Ltd. and other generic-drug companies to continue selling copies.

Steps involved in making Kaletra “do not constitute an invention,” the agency’s Mumbai office said in documents dated Dec. 30. The patent application by Abbott Park, Illinois-based Abbott had been challenged by the Initiative for Medicines, Access & Knowledge, as well as Cipla and Matrix Laboratories Ltd.

Abbott is reviewing the patent decision and determining its next steps, spokesman Scott Stoffel said today. Newer versions of the drug don’t require refrigeration and needn’t be taken with food, making them better suited for patients in developing countries, he said.

Kaletra, which combines two antivirals, is one of the preferred second-line treatments to fight drug-resistant HIV, according to the World Health Organization, which recommends governments include it on their list of essential medicines. The product generated about $1.37 billion in sales in 2009, making it Abbott’s second-best seller after the arthritis drug Humira.

The patent application is 339/MUMNP/2006.

To contact the reporter on this story: Adi Narayan in Mumbai at anarayan8@bloomberg.net.

To contact the editor responsible for this story: Jason Gale at j.gale@bloomberg.net