Global pharmaceutical companies are finding the going tough in emerging markets, with corruption and pricing probes in China and inventory management woes in Brazil. Now the patent regime in India is becoming increasingly hostile.
India’s Intellectual Property Appellate Board (IPAB) has revoked the local patent granted to the British drug maker GlaxoSmithKline for its popular breast cancer drug, Tykerb. As per the ruling, the original molecule—lapatinib—will continue to have patent protection till 2019. But the additional patent on Tykerb, which is the marketed salt version of the compound, and which would have allowed GSK to extend the protection until 2021, was rejected, citing insufficient innovation.
GSK had cut the price of Tykerb to about one-third of what it costs in the US to allay concerns in India about high prices of essential drugs. Ten tablets now costs around 4,160 rupees ($68). Patients with advanced stages of the cancer take around 100 tablets over 21 days.
The pharmaceutical industry is increasingly looking to emerging markets to compensate for lackluster sales in the US and Europe. But this push has brought companies into conflict with governments that want cheaper drugs. One way to get them is by limiting patents, so that local companies can make cheaper generic versions.
India’s $13 billion drug market, where generic medicines account for more than 90% of drug sales by value, has been the stage for some of the biggest such battles. In a landmark ruling in April, India’s supreme court rejected the patent for Novartis’s cancer drug Glivec, saying it was an amended version that was only slightly different from the old one. The drug costs about $2,600 a month, while generic copies are sold for as little as $175. In 2012, India revoked patents on blockbuster drugs including Roche’s hepatitis C drug Pegasys, and Merck’s asthma drug.
And for GSK, the India ruling could not have come at a worse time. The company is mired in a corruption scandal in China that has led to the arrest of over 20 executives. The British pharma major is facing allegations of funneling up to 3 billion yuan ($490 million) to travel agencies to facilitate bribes to doctors and officials.