India denies patent on novel HIV/AIDS medicine

In 2014, several months after Prime Minister Modi took office, he announced an ambitious initiative called “Make in India.” The goal was to encourage foreign and domestic companies to manufacture more products in India in order to spur the kind of economic growth that comes from an innovative economy. With respect to the biopharmaceutical industry, Mr. Modi’s “Make in India” efforts, if successful, would have an added benefit, as more life-saving medicines would be developed and manufactured domestically, thus providing patients with speedier access to the newest treatments. Unfortunately for India’s patients, there are still roadblocks within his government that prevent his vision from becoming reality.

Recently, the government of India denied a patent for a new medicine that would have helped patients suffering from HIV/AIDS. Cipla, an Indian pharmaceutical company, was seeking a patent for a combination of two anti-retroviral medicines, Ritonavir and Darunavir, which had previously been incompatible in a combined single-dosage form. The new medicine had already been granted patents in the United States, Europe and Australia, and represented a significant innovation of great benefit to patients. By finding a way to combine the two medicines into a solid pill form, Cipla greatly simplified patients’ dosing schedules while simultaneously decreasing pill burden. It is precisely these kinds of follow-on innovations that help patients better cope with diseases like HIV/AIDS and improve their quality of life.

Despite the great potential of this new medicine, the Mumbai Patent Office denied a patent for Cipla’s drug citing Section 3(d) of India’s Patent Act, which adds an additional hurdle to patentability standards on medicines, especially follow-on innovations. The Patent Office ruled that Cipla’s new combination of Ritonavir and Darunavir lacked an “inventive step” even though it was a novel invention and did not satisfy Section 3(d) requirements, thus denying patients in India the benefits of an improved version of a powerful HIV/AIDS medicine. Rulings like this are incompatible with Mr. Modi’s vision and seriously compromise the ability of innovators to “Make in India.” Predictable and high-standard intellectual property policies are the lynchpin of an innovative economy, and such rulings create disincentives for companies, whether multinational or India-based, to develop new medicines in India.

There is no reason why India can’t become an economic powerhouse given the resources it already possesses. By strengthening intellectual property protection and removing regulatory and legal obstacles to innovation, India could be a global leader in biopharmaceutical research and development and a top destination for biopharmaceutical investment. Unfortunately, however, India is falling short of its full potential and even Indian companies are feeling the pain.

Nearly two years into Prime Minister Modi’s Administration, there still remains a high degree of uncertainty for innovators who want to do business in India. The Cipla case, where the innovation presented clear benefits for patients, is the clearest example yet that reforms are necessary before India can reach its full potential.