NEW DELHI – In a test of India's law requiring sponsors of patented drugs to manufacture sufficient quantities in country, Cipla Ltd.'s challenge of Novartis AG's Indian patent for its chronic obstructive pulmonary disorder (COPD) drug Onbrez is raising questions about access, price and the correct way to contest a pharmaceutical patent.

At the heart of Cipla's battle is its assertion that rather than manufacturing Onbrez (indacaterol) in India as required after being granted patents in 2008 and 2009, the Switzerland-based pharma giant imported the drug in negligible quantities. For instance, Novartis only imported enough units in 2013 to meet less than 1 percent of the need in the country, which has about 15 million people suffering from COPD, according to Cipla.

The Novartis drug – at Rs677 (US$10.90) for 10 pills – also is out of reach for most of the patients, Cipla maintained. When it launched a competing generic last November, Cipla priced it at Rs130 (US$2) for 10 pills.

"Given that COPD is a chronic disease and that patients often come from poorer socio-economic sections, it's paramount that ways be found to make COPD treatment cheaper," said Anant Bhan, an independent health researcher and adjunct visiting professor at Yenepoya Medical College. If the brand drugmaker can't be convinced to bring its cost down, then a generic cheaper version might be the way forward, he added.

But he acknowledged that even Cipla's price is high for a large proportion of COPD patients in India. "Hence, it's crucial to explore ways to bring down the cost in the public interest, and compulsory licensing and/or allowing for generic versions is one way to address this," Bhan said.

He suggested that the government engage with pharma companies to ensure that drugs are widely available at a reasonable cost. "While the indacaterol case will look at some of these complexities, it would also be useful that addressing the larger picture of accessibility, affordability and availability of much needed drugs to Indian patients is given priority by the government," Bhan told BioWorld Today.

So far, most of the engagement in the Cipla/Novartis challenge has been in court. After launching its generic indacaterol, Cipla asked India's Department of Industrial Policy and Promotion (DIPP) to revoke the Novartis patent due to its alleged noncompliance with the domestic manufacturing requirement that's intended to promote technology transfer.

But last month, the Delhi High Court issued an interim injunction protecting the Novartis patent and restraining Cipla from manufacturing or selling its generic indacaterol. The court instructed Cipla to file for a compulsory license if it believed Novartis was not producing sufficient quantities of the drug. Cipla has since challenged the court's restraining order.

Shamnad Basheer, a patent law expert and a former professor at the National University for Law and Jurisdical Sciences, told BioWorld Today that Cipla should have applied for a compulsory license in the first place rather than seek revocation of the Novartis patent. Cipla has convincingly shown that Onbrez was not being produced in sufficient quantities to meet the public demand in India, but asking for the courts to revoke the patent "is not strategically the best option," said Shamnad Basheer, a former professor at the National University for Law and Juridical Sciences in Kolkata and a well-known patent law expert.

A patent revocation is an extraordinary and discretionary remedy that is invoked by the government. A compulsory license, on the other hand, is a legal entitlement if a company can prove that a drug is not produced in sufficient quantities to meet reasonable public demand.

However, to get a compulsory license, a drugmaker must first try to get a voluntary license from the patent-holder, noted the specialist IP blog SpicyIndia. In this case, Cipla launched its generic without seeking a voluntary license.