for big pharma?
T
he last 12 months have brought a lot of change in India. First, a new government, the Bharatiya Janata
Party, was voted into offi ce in May 2014 and said straight away it would be focusing on, among other things, intellectual property. T en, shortly aſt er the election, Nirmala Sitharaman, the new commerce and industry minister, said India would “constructively engage” with the US—a long-term critic of its IP regime—about it. T e US Trade Representative’s annual Special 301 Report had included India on its ‘priority watch list’ (the report assesses US trading partners’ eff orts to protect IP, and was released a few weeks before the general election). However, these two developments suggested that fears concerning India’s patent laws, particularly those surrounding pharmaceuticals, might soon be addressed.
One of those fears centred on compulsory licences, with major pharma companies worrying that Indian courts favour providing access to cheaper medicine over protecting patent rights. Almost three years have passed since what was arguably the catalyst for much of the concern. In 2012, India’s controller general of patents and designs granted Natco Pharma a compulsory licence to produce a generic version of anti- cancer drug Nexavar (sorafenib), made by German pharma company Bayer. T e licence, which at the time enabled Natco to sell the drug at 8,800 rupees ($175) for a month’s dosage, rather than Bayer’s 280,000 rupees, was divisive. Some commentators claimed that it rightfully granted cheaper access to medicine for those who could not aff ord it, and others claimed it showed a disregard for patent rights. Before that ruling, there were three other applications for a compulsory licence in India, but none has come to fruition. In 2007, Natco fi led applications against Roche’s anti-lung cancer drug Tarceva (erlotinib) and Pfi zer’s carcinoma treatment drug Sutent (sunitinib malate), but later withdrew them. T e third, also fi led by Natco, concerned Bristol Myers Squibb’s drug Sprycel (dasatinib), and was dismissed by the Indian Patent Offi ce (IPO) in 2011. T e compulsory licence issue has now reared its head once more, in the form of a closely followed battle between European pharma company Novartis and Indian generic maker Cipla.
T e case centres on Onbrez (indacaterol), Novartis’s treatment for chronic obstructive pulmonary disease (COPD).
ZZVET /
SHUTTERSTOCK.COM
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