Yet because the case is mind-numbingly complex and it has only been possible to patent drugs in India for a few years – so only a few are sold at brand-name prices – the Indian public is barely paying attention, unaware of its potential impact, said Amit Sengupta, a co-ordinator with a health access organization called the People’s Health Movement.
The ramifications of the case go far beyond Glivec. They reach into the tiny Delhi apartment of C. N. Patel, a 55-year-old oil driller who has been living with HIV since 1996. Five years ago, he collapsed on the job; tests found his immune system so shredded by the virus he was next to dead. He started on the most common course of anti-retroviral drugs, and recovered somewhat – but soon discovered his virus was resistant to those drugs and he needed a “second-line” combination of drugs.
Right now, he takes generics, which he gets free through the national AIDS program. But Abbott and BMS, which hold the patents on his drugs elsewhere, have already applied in India and are watching the Glivec decision. There’s no way to tell what they might charge for Mr. Patel’s drugs if they regain their monopoly, but other patented AIDS drugs are sold for $6,000 a year here, about what his family lives on.
“I can’t pay,” said Mr. Patel. “My pension is gone. My savings are gone. I can’t get more loans. If they win this lawsuit, I’ll just die.”
India inherited its original patent law from the British and it barred the country from producing local versions of patented drugs such as malaria medications or the first antibiotics. Indira Gandhi, as prime minister, was incensed to learn India was paying higher prices for medicines than many Western countries. In 1972, at the height of the Green Revolution, she oversaw the adoption of a law that made it illegal to patent food or medications in India.
The country was then short of technology, but rich in skilled biochemists, who rallied to a Gandhian cry of self-reliance and began to “reverse engineer” Indian versions of many brand-name drugs. By the mid-1990s, the public sector research had led to a thriving private sector generic industry, making drugs for both internal consumption and export.
When India joined the World Trade Organization in 1995, though, it had to agree to start granting patents on medicines by 2005. Leftist parties then in the governing coalition, seeking to keep the law from being what they saw as excessively pro-business, included a clause saying a new form of a known substance cannot be patented unless it has shown enhanced “efficacy.”
The language was unusual for patent law, and aimed at stopping “evergreening” the practice multinational pharmaceutical companies use to extend their patent terms beyond the usual 20 years by making minor changes in their existing medicines, filing for a new drug and thus keeping a monopoly.
Multinational drug companies complained about the language from the outset. Novartis tried and failed to have efficacy clause ruled unconstitutional Now its focus is persuading the Supreme Court that efficacy is being unfairly restricted to therapeutic effectiveness, and should include modifications that make drugs “bioavailable,” or easier to absorb.
The situation with Glivec – which changed chronic myelogenous leukemia from a fatal to a manageable illness – is tricky. The original compound was developed in the United States,., mostly in publicly-funded laboratories, and patented there and elsewhere in the early 1990s by Novartis – well before India had patents. In 1997 Novartis applied to patent a salt form of the molecule, and increase the length of the patent by five years. It filed that patent here in 1998 – knowing that by 2005 India would have to start examining them. The company managed to have most of the generic makers shut down in 2004 – but when the patent was rejected in 2006, lifting the barrier to generics, it decided to go after the ‘efficacy’ section of the law as a whole.