India's Supreme Court is expected to rule soon on a patent for Novartis' ($NVS) groundbreaking cancer treatment Gleevec, and Big Pharma and international aid groups are waiting with bated breath to see how it turns out, each for different reasons.
The industry says that India has got to recognize intellectual property rights if it wants drugmakers to bring the benefits of expensive development to its growing middle class. "This case is about safeguarding incentives for better medicines so that patients' needs will be met in the future," Novartis spokesman Eric Althoff tells The Associated Press.
Aid groups, however, believe without cheap generics from Indian drugmakers, millions of poor people will suffer and die. "The implications of this case reach far beyond India, and far beyond this particular cancer drug," Leena Menghaney, with Doctors Without Borders, tells the news service. "Across the world, there is a heavy dependence on India to supply affordable versions of expensive patented medicines."
Companies such as India's Cipla and Lupin have become the primary source of cheap generics of AIDS, cancer and malaria drugs for countries that would never be able to afford branded products. But India's generics industry can sell them at about a tenth of the branded cost because they have no development expense to amortize. That is no different than any generic drug approach except that India has been libertine in terms of ignoring existing patents that are protected elsewhere in the world.
In March 2012, India for the first time invoked its compulsory licensing rules. It gave to domestic drugmaker Natco Pharma the right to make and sell a version of Bayer's cancer drug Nexavar--despite the fact that Nexavar is still on patent. Natco will pay a 6% royalty, but given it charges only $170 a month compared with Bayer's $5,000-a-month price, Bayer stands to earn very little. Cipla has said it will offer a version of the drug at $130 a month.
The industry sees great potential for selling drugs in India but also is realizing that comes with some serious potential downsides. Whichever way the court rules, the decision is expected to have very broad implications for the industry for years to come.
- here's the Associated Press story