Drug-resistant tuberculosis (DR-TB) has posed a significant public health challenge for decades. Patients lucky to be diagnosed faced the ordeal of treatments that often caused severe adverse effects, including permanent disability. The intellectual property-driven research framework has done little to encourage the development of new drugs for neglected diseases that mainly affected people in developing countries, and DR-TB is no exception.
After 50 years, a new drug to treat TB — bedaquiline — was approved. It had been developed with significant public funding, including from the United States National Institute of Allergy and Infectious Diseases. Bedaquiline is now core to WHO-recommended treatment regimens, thanks to the collective work of the TB community and treatment providers. Despite the joint effort, it is J&J that holds a monopoly on the drug in many countries. The public and philanthropic contributions cannot be ignored but warrant a guarantee that bedaquiline does not remain under the proprietary control of J&J.
J&J currently enjoys a 20-year monopoly over bedaquiline until July 2023, when its primary patent expires. With generic competition anticipated this July, the price of bedaquiline could fall by up to 80 percent. This lower price will enable increased roll-out of bedaquiline containing treatments and save lives.
However, J&J has applied for additional secondary patents, like on the fumarate salt form of bedaquiline in 20 of the 30 high-burden countries. Granting this secondary patent in India will extend J&J’s patent monopoly until December 2027, making it difficult for alternative suppliers to provide more affordable generics for four more years. To prevent this, two TB-survivors and a patients’ group challenged J&J’s secondary patent application at the Indian Patent Office (IPO). In November 2019, the Managing Director of Janssen India (J&J’s pharmaceutical division), publicly stated that come July 2023, generic manufacturers will be able to make their own versions of bedaquiline. Yet, in contradiction to its statement, J&J aggressively pushes for the grant of a secondary patent before the IPO, which will delay generic competition.
TB is not an individual battle — it takes collective effort to develop and deliver affordable treatments.
In this case, J&J needs to show it’s not just making empty promises and remove barriers to early availability of generics by withdrawing the secondary patent in India and other high-burden countries. Nevertheless, in true spirit of the Indian patent law, separate patents on routine changes to the same medicine should not be encouraged.
The writer is a lawyer and works with Médecins Sans Frontières (MSF-Doctors without Borders) Access Campaign. Views are personal.