Is intellectual property safe in India? That's the question drugmakers--and now U.S. officials--are asking, as the country's top court considers a landmark patent case, and after the government ordered its first compulsory license on a Big Pharma-patented drug.
The issue drives to the heart of pharma's push into emerging markets; after all, if innovative drugs aren't protected, then how can the makers of those drugs profit? But, at the same time, developing countries--and the citizens who can barely pay for food, much less medication--can't afford to pay the prices demanded in mature markets. And what good is a lifesaving drug if only a tiny fraction of patients can use it?
Not surprisingly, U.S. Commerce Secretary John Bryson came down on Big Pharma's side, The Economic Times reports. During a visit with Indian Commerce Minister Anand Sharma, Bryson protested the government's order that Bayer ($BAY) allow domestic drugmaker Natco Pharma to knock off its cancer drug Nexavar at a vastly reduced price.
Bryson told Sharma that "(a)ny dilution of the international patent regime was a cause for deep concern for the U.S.," a government official told the ET. But Sharma countered, saying the World Health Organization's compulsory licensing provisions were established for cases just like this--life-threatening illness treated by a drug out of reach at brand-name prices.
Meanwhile, India's Supreme Court is hearing arguments in Novartis' ($NVS) long-running patent dispute. The fight involves the Swiss drugmaker's groundbreaking cancer treatment Gleevec, which India's patent officials deemed unworthy of market exclusivity. The case not only determines the fate of Gleevec--and the patients who need it--but could affect access to HIV drugs and other treatments now produced and sold at low cost.
If Novartis succeeds in striking down the Indian patent provision in question, "it will open a flood of patents," Leena Menghaney, a lawyer with Médecins Sans Frontières, told the Globe and Mail. And that could make many drugs suddenly inaccessible.
But Novartis maintains that access to medicines depends on patent protection. The company "is seeking clarity on whether we can rely on patents in India and whether we as a research-based organization can continue to invest in the development of better medicines for India," Novartis' top official in India, Ranjit Shahani, told the newspaper. We'll soon see how the Indian justices feel.