amfAR, The Foundation for AIDS Research

Indian Supreme Court Ruling Preserves Access to Low-Cost Drugs

In April 2013, the Indian Supreme Court upheld a portion of India’s patent law critical to preserving the nation’s generic drug industry when it ruled that the Swiss pharmaceutical company Novartis should not receive a patent for its leukemia drug Gleevec®. India is the world’s largest producer of generic drugs and manufactures more than 80 percent of the low-cost HIV medicines used to treat HIV-positive individuals in low- and middle-income countries. The patent lawsuit threatened that life-saving supply.

“The Supreme Court’s ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines,” said Giten Khwairakpam, TREAT Asia’s project manager for community and policy.

Novartis’s seven-year legal battle against India’s 2005 Patents Act focused on one section of the act, Section 3(d), that prohibits frivolous patent extensions for minor changes to existing drugs that do not significantly improve their efficacy. This practice is known as “evergreening” because it extends pharmaceutical companies’ monopolies on drugs and prevents generic production. The court’s decision affirmed that Gleevec is too similar to a previous drug to warrant a new patent under Section 3(d), and rejected the company’s contention that the section violates their intellectual property rights.

Loon Gangte of the Delhi Network of Positive People (DNP+) called the decision, “A crucial victory for people living with HIV and other diseases who can continue to rely on India for access to affordable treatment,” adding, “We have been filing several oppositions to patent applications on ARV medicines on the basis of Section 3(d).”

Novartis denounced the ruling as a symptom of “India’s growing non-recognition of intellectual property rights that sustain research and development for innovative medicines.” Yet India has granted hundreds of patents since it enacted its Patents Act to comply with international trade standards. The only patents it does not grant are those considered to be cases of evergreening, as opposed to real medical innovation.

Free trade agreements (FTAs) like the Trans-Pacific Partnership (TPP) now threaten to thwart this progress towards improved access to generic drugs. The U.S. and a number of countries in Asia and the Pacific are currently negotiating the TPP. As with many FTAs, current proposals require that member nations adopt stringent intellectual property provisions similar to those in the U.S. that would delay the availability of generic medicines and decrease competition among generic drug manufacturers. However, this competition caused the price of first-generation HIV medicines to plummet from $10,000 per person per year in 2000 to as low as $60 today. The price of free trade could prove to be very high for those living in the world’s poorer countries.