Cipla asks India to revoke Novartis patents on respiratory drug

By Zeba Siddiqui

MUMBAI (Reuters) - Generic drugmaker Cipla Ltd said on Thursday it has asked the Indian government to revoke five patents held by Swiss firm Novartis AG on respiratory drug Onbrez and has launched a cheaper copy to boost access in the local market.

Cipla alleged that Novartis has had patents on the medicine since 2008 but instead of producing it in India has imported a "negligible quantity" from Switzerland, leading to a shortage of supplies in the Indian market.

Big international pharma companies have been hit by wide-ranging government-imposed price cuts and legal battles over patent protection in recent years in India, a vital growth market.

Cipla, India's fourth-largest drugmaker by revenue, said because there was an urgent but unmet need for the respiratory treatment in India it has started to sell a copy of the drug in Delhi priced at a fifth of the cost of Novartis's product.

"Cipla believes that it has the potential to manufacture adequate quantities of the drug and make the same available in the country," the company said in a statement, confirming its request to the government for the patents to be revoked.

A spokeswoman for Novartis in Zurich said the company had not received any notice from regulatory or other authorities about the issue.

Cipla's action is likely to result in a prolonged legal battle between the two companies, analysts said.

A senior official at the Indian government's Department of Industrial Policy and Promotion said Cipla's filing about Novartis's patents was made under Section 66 of the Indian Patents Act.

The section grants the Indian government the power to revoke a patent in the public interest, after giving the patent holder an opportunity to explain why it should not be revoked, said the official, who declined to be named.

Onbrez, chemically called indicaterol, is used to treat breathing problems associated with chronic obstructive pulmonary disease (COPD). Cipla estimates more than 15 million Indians are afflicted with the disease.

Novartis has been particularly vocal in its criticism of India's patent laws after the country's Supreme Court last year denied the company a patent on its cancer drug Glivec, allowing Indian firms to launch cheaper copies.

The United States Trade Representative (USTR) said this year India's limits on the approval of pharmaceutical patents and its plan to open patented drugs to generic makers created "serious challenges" for some innovators.

New Delhi is working on a new intellectual property policy, and the government will also set up a think-tank to advise it on global intellectual property issues, Trade Minister Nirmala Sitharaman said last month.

(Additional reporting by Caroline Copley in Zurich; Editing by Sumeet Chatterjee and Greg Mahlich)