Cipla petitions India to revoke Novartis respiratory drug patents, launches low-cost version of drug

Amid growing discontent from Big Pharma companies over India's patent-busting policies, generics maker Cipla is petitioning the country's government to revoke 5 patents for Novartis' ($NVS) COPD drug Indacterol. The Indian company isn't waiting for a decision to launch a low-cost version of the product to boost local access.

The Mumbai-based company rolled out a generic copy of the product under the name "Unibrez," and asked the country's government to throw out the Swiss drugmakers' patents, citing a public healthcare need as a reason behind its petition. Novartis' product is 400% more expensive than Cipla's generic version, and the Swiss company only brought in 53,844 units of the drug in 2013, serving 4,500 patients annually, The Economic Times reports.

"Novartis has been granted these patents since 2008-09 but has chosen not to manufacture the same in India. Novartis merely imports a negligible quantity of these products manufactured in Switzerland as per its own data filed before the Patent office," Cipla said in a statement (as quoted by The Economic Times).

But when asked about Cipla's recent petition, Novartis told the newspaper it had "not received any notice from regulatory or other authorities about this issue."

This is not the first time Novartis has encountered patent pushback in India. In 2013, the country's Supreme Court rejected the company's bid for an Indian patent on its cancer drug, Glivec, opening the door for generic competition.

Cipla is also waging patent battles on other fronts, duking it out with pharma giant Roche ($RHHBY) over patents for a lung cancer drug. In 2012, a Delhi high court ruled that Cipla's generic version of Roche's drug erlotinib did not infringe on an Indian patent, and denied the Swiss company's request for an injunction. Roche appealed the case and the high court appointed a mediator to end the tussle. But the mediator on Friday threw in the towel, sending the case back to high court for further deliberation.

Meanwhile, India continues to deal with drugmakers' discontent over its patent laws and practices. Earlier this month, the country's DIPP agency delayed a decision on whether to grant a compulsory license for Bristol-Myers Squibb's ($BMY) leukemia drug Sprycel, dealing the drugmaker a much sought-after victory. But other companies have not fared as well in recent years, with big names like Pfizer ($PFE) and Roche suffering the loss of Indian patent protections for its cancer drugs.

The topic of IP protection was discussed when India's new prime minister, Narendra Modi, made his first trip to the U.S. in September. The two countries agreed to have ongoing discussions on the matter. 

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