Novartis sues Cipla over respiratory drug Onbrez, HC reserves verdict

Novartis AG, the Swiss drug manufacturer, said on Wednesday it had sued Cipla for infringing patents covering its respiratory drug Onbrez, a month after the home-grown drugmaker launched a copy at a fifth of the original drug's price.

Onbrez, chemically called Indacaterol, is used to treat chronic obstructive pulmonary disease in adults, and patents covering the drug expire only in 2020.

Cipla, the country's fourth-largest drugmaker by revenue, launched its copy of Onbrez in the national capital in October, citing urgent unmet need for the drug in the domestic market.

"There is an ample supply of Onbrez, and Cipla's claims that there is a shortage of Onbrez lack any substance," Novartis spokeswoman Svetlana Pinto said in an emailed statement, confirming the filing of the patent suit.

A Cipla spokeswoman declined to comment because the matter is sub-judice.

The Delhi High Court, however, reserved its verdict on the drug patent dispute. Justice Manmohan Singh reserved the judgement after hearing detailed arguments on behalf of both the drug firms.

Novartis sought to permanently restrain Cipla from manufacturing Indacaterol in any form and selling it in the country. It also sought damages and payment for infringing the patented pharmaceutical product.

Novartis said it is partnered with generic drugmaker Lupin to sell the drug in the domestic market.

{expertcomment}Cipla said in October it had asked the government to revoke five patents held by Novartis on the drug. The Department of Industrial Policy and Promotion is yet to decide on that, and a spokesperson was not immediately available to comment.

The Swiss drugmaker did not provide any details on the lawsuit, but termed Cipla's request for revocation of the patents as "unfounded".

"Cipla did not use any of the processes provided for in the Indian legal system to either challenge validity of the patents, establish non-infringement or to seek a license for these patents," the Novartis spokeswoman said.

The case is the latest salvo between a foreign and domestic drug firm over intellectual property.

The United States Trade Representative (USTR) said earlier in 2014 that the country's limits on the approval of pharmaceutical patents and its plan to open patented drugs to generic makers created "serious challenges" for some innovators.

The government is currently working on revamping its intellectual property policy.

(Reuters)