Congratulations to India’s Supreme Court, to health activists worldwide, and to the Lawyers Collective who argued on behalf of patients and won an important ruling this week that protects access to lifesaving medicines in India and around the world. The Court upheld a clause in Indian patent law requiring that patents are only granted to truly novel and innovative medicines, and not for incremental changes to already known compounds.
Monday’s decision was a very big deal. Currently India produces one-fifth of the world’s generic medicines, half of which are exported abroad, mostly to developing countries. At stake in the case was India’s ability to continue to produce these generics.
What happened in India to put access to medicines in such jeopardy? The answer is a seven year saga of corporate greed that repeatedly valued profits over access to life-saving medicines. Since 2006, Novartis, a Swiss based pharmaceutical company, has tried to force the Indian government to grant them a patent for Glivec, an important medicine that treats certain types of cancers. But the Indian patent office refused based on lack of novelty, and activists have mobilized in support of this decision ever since.
Before 2005, India didn’t recognize patents on medicines. This policy environment nurtured a vibrant domestic generic industry, which became a major supplier of medicines at greatly reduced prices to the world. For instance, India produces 80 percent of the AIDS medicines that are keeping 8 million people alive today. Quality Indian generics can be 10 to 100 times cheaper than their branded counterparts. To comply with World Trade Organization rules, India had to introduce medicine patents in 2005. However, to strike a balance between patent rights, innovation, and public health interests, and to maintain their ability to produce affordable medicines, India chose to limit patenting to innovative medicines only. One cannot obtain patents on combinations or new formulations of already existing drugs, or on “new” medicines that are, in fact, only minor modifications to existing ones.
This was the case with Glivec: The active substance used in this medicine was a minor modification to one that was already known to have a similar therapeutic effect. Already in 2005, a generic form was available on the market in India for about $190 per month. At the same time in the United States and some EU countries, Novartis was marketing it for $2,500 per month. Considering this price difference, one can only wonder how many lives would have been lost if India had initially issued Glivec a patent in 2005, or what the future would hold if the Indian Supreme Court had ruled in favor of Novartis this week.
The Novartis court case in India wasn’t just about Glivec. It was about Big Pharma trying to flex its power, pressuring the Indian government and its patent office to issue lots of other patents on medicines regardless of whether they are deserved. Trying to get such frivolous patents for minor modifications to existing medicines (a strategy known as “evergreening”) isn’t something pursued only by Novartis, it is what all the big pharmaceutical companies are doing. Such profit-maximizing, or “life-cycle management” as it is called in business terms, rather than research and development of truly innovative medicines is central to today’s pharma business model. Despite the pharmaceutical companies’ claims around innovation, only about 5 percent of newly marketed drugs are considered real breakthroughs in terms of therapeutic benefit. Over half of the new medicines have no new benefit at all, or are inferior to already existing drugs.
Rather than bending the rules of the patent system to obtain broader and longer patent protections on already existing medicines, we need to have a global conversation about how to create genuine medical innovation that addresses people’s health needs and delivers affordable medicines to all. This will require moving beyond the dogma of patent monopolies and high prices as the sole incentive for research and development, and towards open and collaborative innovation models that serve the public interest. And since GlaxoSmithKline boss Andrew Witty now admits that the assumed US$1 billion price tag for the research and development of a new drug is “one of the great myths of the industry,” we know this is a realistic possibility.