Initiative for Medicines, Access & Knowledge (I-Mak), a New York–based advocacy group, has fired the opening salvo of what is likely to be a lengthy battle with Gilead and other companies over access to HCV drugs in low- and middle-income countries. I-Mak has filed a pre-grant opposition in India to one of Gilead's key patents for Sovaldi, known in India as Application Number 3658/KOLNP/2009. Others are in the offing. “It's not just going to be in India—it's going to go wider than India,” I-Mak co-founder and director of intellectual property Tahir Amin says. “There's probably going to be action on some of the other direct-acting antivirals as well.” (In the US, Merck and Cambridge, Massachusetts–based Idenix are also opposing Gilead's Sovaldi patents.)
Most of the world's HCV-infected population, which is estimated at around 185 million people, lives outside of the wealthy regions of North America and Europe, as do most of the estimated 350,000 people who die every year from liver diseases associated with HCV infection. India has 10–12 million HCV patients. Egypt has the world's highest prevalence rate, with an estimated 7 million cases in a population of 85 million, a legacy of poorly conducted anti-schistosomiasis campaigns over several decades. I-Mak, whose donors include the Open Society Foundation, founded by investor and philanthropist George Soros, is attempting to use India's patent laws as a lever to force Western pharmaceutical firms to cut their prices to affordable levels.
“India has laws that are more stringent in terms of what is regarded as new or novel,” Amin says. Its initial opposition concerns Sovaldi, which is administered as a prodrug but which, according to I-Mak, is based on claims that are covered or anticipated by an earlier application concerning the base uridine analog to which Sovaldi gives rise. “Technically they're trying to double dip and get another four to five years patent life,” he says. Moreover, he claims the same compound was disclosed in a paper (J. Med. Chem.50, 1840–1849, 2007) published electronically on March 17, immediately before the patent application filing in India, which was completed on March 30, 2007. I-Mak will also contest the previous patent, on the basis that the compound was already known. The initial patent application has already been refused by the Indian Patent Office, Amin says, despite Gilead's objections. “Once we file our opposition and evidence, we believe it will only solidify the patent office's refusal,” he says. Although still in its infancy, the dispute is strongly reminiscent of the ongoing struggle between HIV patient advocates and the pharmaceutical industry—except it is likely to get even bigger, given the scale of the global HCV pandemic, which dwarfs that of the HIV pandemic.