The following is a guest blog post by Professor Brook Baker of Northeastern University’s School of Law, Program on Human Rights and the Global Economy, describing and commenting on pharmaceutical company Novartis’s court challenge to India’s strict standards of patenting medicine — standards that have increased access to affordable generic medications worldwide — and the Novartis protests that ensued last week.
Fifty AIDS activists, students, and community group members protested at Novartis’s Institute for BioMedical Research in Cambridge, Mass., on February 22 – the eve of the Swiss pharmaceutical company’s annual shareholders meeting in Basel, Switzerland. The protest was part of a global day of action drawing attention to the pharma giant’s pending lawsuit against cancer patients and the government of India, aiming to reinterpret India’s strict patent standards.
Novartis is seeking to establish a binding court precedent that will make it much easier to obtain overlapping and successive patents on minor variations to existing medicines – a precedent that will increase the number of patents on medicines and extend the length of patent monopolies, thereby limiting and delaying generic competition. In the absence of generic competition, Novartis and other “Big Pharma” companies will be able to set prices affordable to elites, but unaffordable to the broad mass of poor people in India. Because India is the “pharmacy of the developing world,” Novartis’s case threatens affordable global access to all categories of life-saving and health-enhancing medicines.
Indian generic companies manufacture 80 percent of the antiretrovirals used to treat people living with HIV/AIDS around the world. Although the manufacturing of existing AIDS and other medicines is not threatened specifically by this court case, the threat with respect to newer and future medicines is very real. With more frequent and longer patent monopolies, poor people and poor governments will be priced out of access for many, many years.
This court case is part of a long series of legal actions by Novartis designed to eviscerate India’s lawful efforts to restrict the widespread practice of “ever-greening” by pharmaceutical companies. In these instances, pharmaceutical companies seek new or additional 20-year patent monopolies for minor changes to existing medicines and chemical entities based on those minor changes.
In the present case, scientists had invented a basic compound imatinib, which is used to treat certain cancers. It was first patented globally in 1993, but not in India. Thereafter, researchers at Novartis tweaked the basic compound, resulting in a 30 percent improvement in the drug’s absorption into the body. This revised active pharmaceutical ingredient became the basis of a powerful anti-cancer medicine called Gleevec in the U.S. and Glivec in India. In 1998, Novartis filed a patent application on the revised drug in the India Patents Office and in many other countries.
Although the Gleevec/Glivec patent was granted in 40-plus countries that had relatively weak patent standards, the patent was denied in India for three simple reasons:
- Prior to 2005, India (like many countries before it) did not grant patents on medicines at all. Although the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) forced India to start granting patents on medicines in 2005, TRIPS did not require India to retroactively grant patents on medicines invented before 1995.
- India enacted Section 3(d) of its patent law, a so-called exclusion that does not ordinarily allow patenting of variations, new uses, new combinations, and new formulations of preexisting chemical entities.
- India incorporated a narrow exception to the no-patent-for-variations rule if, but only if, a patent applicant could demonstrate that changes to an existing substance actually showed significantly increased efficacy – which the Indian courts decided does not include changes in absorption, among other things.
Novartis continues to take action to reverse the patent’ office’s denial of its patent application, and allow section 3(d) to be reinterpreted to allow routine “ever-greening” of minor modifications to existing medicines based on a minimal showing of any positive effect.
Demonstrators in Cambridge Wednesday tried to deliver a Silver Urn (for the ashes of people who would die if Novartis’s court challenge is successful) to Novartis officials, but they were barred from the building and ordered off the premises by Cambridge police. Demonstrators in Washington, DC, delivered an “indictment” against Novartis’s CEO, and protesters in New York City “occupied” Novartis offices.
Organized by Health GAP, Student Global AIDS Campaign, Occupy Boston Health Justice Group, these protesters and others were joined by a larger group of protestors at the Novartis annual general meeting in Basel, Switzerland. There, activists from Act Up Paris, Act Up Basel, Medicines Sans Frontieres, Oxfam, the Berne Declaration and others showed videos and interacted with shareholders, many of whom were sympathetic to the campaigners’ protests against Novartis’s lawsuit.
In response to the protests, Novartis issued a statement to Pharmalot: “We believe that working through the judicial system is the legitimate and appropriate approach to gaining clarity on the unique aspects of India’s patent law …. We disagree with assertions … that access to medicines is threatened by our case. The basis of this argument is false and very misleading. Currently available generic drugs launched in India before 2005 – including HIV/AIDS medicines and generic versions of Glivec – will continue to be available under a grandfather clause in the Indian patent law regardless of the legal outcome of our case. All pharmaceutical products, including HIV/AIDS medications, have been patentable in India under the existing patent law since 2005, and some have been patented.”
This defense is patently evasive – the part truth that tells a lie. Yes, there is some degree of grandfathering, even for Glivec; yes, since 2005, India has patented some medicines. However, India has tried to limit patent monopolies, to address public health needs, and to ensure access to medicines within the bounds of the TRIPS Agreement. Novartis’s statement ignores that is trying to erase those legislative efforts, hiding behind the fig leaf of seeking “clarity.”