As Prime Minister Narendra Modi makes his first official visit to the United States, one issue on top of the trade agenda will be the strikingly different approaches of the Indian and U.S. governments towards intellectual property for medicines, particularly when patented life-saving medicines are priced out of reach of patients.
As the ‘pharmacy of the developing world’, India plays an immensely important role in supplying affordable medicines to people worldwide. These include many patients treated in Doctors Without Borders/Medecins Sans Frontieres (MSF) medical projects in more than 60 countries, including India.
But for years, India has faced a barrage of criticism and pressure from U.S. and the European Union, multinational pharmaceutical firms and their lobbyists over its progressive intellectual property policies. In the U.S., India is the target of unwarranted and purposely misleading accusations of unfair intellectual property laws and not “playing by the rules”. The U.S. Trade Representative placed India on its Special 301 Trade list, a blacklist of countries whose laws and actions don’t comport with U.S. interests on intellectual property, particularly those of the U.S. pharmaceutical industry.
Congressional hearings and an International Trade Commission (ITC) investigation have also taken aim at India’s policies. In actual fact, India’s laws were changed in 2005 to comply with the World Trade Organization’s mandates for pharmaceutical patenting, and over the past decade India has granted an increasing number of patents on medicines.
So why is the U.S. pharmaceutical industry crying foul over India's policies? Because India has a law that limits the granting of secondary and unnecessary patents.
This means that companies are not granted patents for obvious modifications of existing products; however, companies are granted patents for new medicines that contribute to the pool of treatment options available to patients. In the U.S., it is standard practice for pharmaceutical companies to file for and obtain multiple patents relating to different aspects of the same medicine. It's a way to extend patent protection and block generic competition for as long as possible.
After existing asthma medicines were allowed to be re-patented with slightly modified inhalers, generic asthma inhalers disappeared from the U.S. market. Protected by extended patent terms, asthma inhaler patent-holders in the U.S. now charge exponentially higher prices and have kept generic competitors out of the market long after the patent on the original medicine expired. For more than seven years, Novartis fought India’s safeguard against secondary patenting in court, insisting that its patent claims on a salt form of a cancer drug deserved patent protection. Novartis took the case to the Supreme Court in India and lost.
In 2012, for the first time, India issued a so-called ‘compulsory license’ – when a government overrides a patent monopoly to make medicines available to meet a public health need. This measure is used to jumpstart generic production and allows generic manufacturers to enter the market by paying a set royalty fee to the patent-holder. India’s compulsory license auhorised marketing of a more affordable version of a liver and kidney cancer medication that Bayer was selling for $6000 per month in India; generics are now available for less than $200 per month.
To understand what is at stake, think back to a decade ago, when first-line medicines for HIV/AIDS cost more than $10,000 per patient per year. While many AIDS patients in the U.S. and Europe were coming back to life thanks to HIV medicines known as antiretrovirals, people in developing countries where MSF works continued to die simply because they were unable to afford the cost. The Indian generic industry stepped up, offering to produce the same first-line HIV medicines for $1 a day.
Today, 11 million people are on HIV treatment in developing countries, with 90% of medicines sourced in India.
Broad access to affordable HIV medicines has enabled an unprecedented global response to a disease that once seemed completely unstoppable. India’s patent law and practices are reasoned, public-health driven policies, put in place through a democratic legislative process, and in line with international trade and intellectual property rules. Every country has the right to set policies that balance private business interests with public health needs. India has forged a fair and progressive path in this arena that is influencing its BRICS peers and other developing countries. South Africa and Brazil are looking to reform their patent systems to encourage public-health driven innovation and discourage patent abuse.
Prime Minister Modi should reject any attempts to turn India back from this path. Moving forward, we need a bold new vision for biomedical innovation where open access to scientific knowledge is promoted and where R&D investments are not linked to the price of products, making medicines affordable for all who need them. India can show even greater leadership by supporting proposals being considered at the World Health Organization and other national and regional forums to implement new models for medical innovation.
Funding for medical research and development, as well as vision, leadership and the right policies, are needed to transform these proposals into action.
We urge the Prime Minister to stand firm in upholding India’s public-health driven intellectual property policies, which are in line with international trade and intellectual property rules and which are the foundation of India’s vitally important role in global health.
As a medical humanitarian organization that relies heavily on affordable high quality medicines produced in India, we have seen firsthand the lifesaving role that Indian patent law safeguards and the Indian judiciary have played over the past decade. We implore Prime Minister Modi to continue India’s leadership in global health, innovation and access to medicines, by not only playing by the rules but also by challenging the patent system and changing the innovation system so it better serves public health needs.
- Meenakshi Narula Ahamed is a trustee of MSF India and is a member of MSF-USA’s Board of Advisors. Unni Karunakara is a trustee of MSF India and is the former international president of MSF.