It's the first drug to be approved for the treatment of tuberculosis in the last 40 years. Now, a decade after bedaquiline, the TB drug, got a patent in India in 2009, it is caught in a patent battle. This week, two tuberculosis survivor-activists have filed a patent challenge against pharmaceutical corporation Johnson & Johnson (J&J), the global manufacturer of bedaquiline. This, the two said in a statement, is to prevent the pharma giant from “extending its monopoly” on bedaquiline.
The two activists, Mumbai-based Nandita Venkatesan and South Africa-based Phumeza Tisile, filed the patent challenge at the Mumbai Patent Office on Thursday. Both survived drug-resistant TB (DR-TB), but lost their hearing because of the toxic and painful treatment that included injectables. However, with the new drug bedaquiline, which is safer and more effective, these side-effects that patients had to endure because of injectables are history. By filing a patent, the two say they are fighting to make the drug affordable and accessible to everybody with DR-TB.
Currently, in India, the incidence (new cases each year) of DR-TB is close to 1.5 lakh. According to the WHO's latest guidelines that were released in 2017, the new drug should be administered to all these patients. However, since India has not updated its guidelines (bedaquiline is only given to those who have DR-TB and fluroquinolone-resistance), as of now, only 22 per cent of these patients are eligible for the new drug.
The story of the bedaquiline patent began in 2005, when J& J filed for a patent on the “base compound” or the Active Pharmaceutical Compound (API) at the patent office in Delhi. The patent was granted in 2009, and is valid until 2023. The same year (2009), the company also filed a patent claim for the salt (fumarate) contained in the drug, which was challenged by the Network of Maharashtra People Living with HIV (NMP+) in 2013. In 2018, the company amended its claims to add another component to the base salt (fumarate), which is now being challenged by the latest petition.
Even as that 2013 opposition is being examined, the company altered its patent claim, representatives of MSF told The WEEK.
MSF is supporting the latest patent challenge. “Janssen Pharmaceutical N.V. (Janssen), a subsidiary of the US pharmaceutical corporation J&J, has filed for multiple patents on bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake claim on routine improvements and formulations. Currently, Janssen exerts control over the market until 2023, when its compound patent is set to expire. Should the company get a secondary patent on the fumarate salt of bedaquiline, it will further delay the entry of alternative suppliers to the market until the end of 2027,” said Leena Menghaney, Head, South Asia, MSF Access Campaign.
Menghaney said that in India, a majority of pharmaceutical patents are filed for “secondary claims”, that is, “for marginal improvements on patented drugs that already exist and should not be granted protection again”. “Such ‘evergreening’ tactics allow pharmaceutical corporations to maintain exorbitant drug prices by extending their monopoly on the market and delaying the introduction of alternative sources of drugs. This blocks Indian generics manufacturers from producing lower-priced generic versions of drugs—including child- friendly formulations— despite their technical capacity to do so,” she said.
Currently, in India, bedaquiline is being provided to DR-TB patients through the government's “conditional access programme”. Under this programme, the government has received 10,000 courses of the drug (one course equals six months per patient)—of this, it has been able to use only 3,000 courses until now—from J&J (through a donation from the USAID). The donation ends this year, after which India will have to buy the drug. Currently, the cheapest version of the drug is available in South Africa where it costs $400 per course of six months. The price of the drug should be no higher than $500 dollars per course in low and middle income countries, and high-burden countries, according to MSF.
Once the donor support is over, India will have to buy the drug, and at that time, the price of the drug will matter, Menghaney explained. “If there are alternate suppliers, the drug price is bound to become affordable for us,” she said.