Bedaquiline patent win is a half victory

India's ability to eliminate its huge TB burden by 2025 will be a test of both its patent laws and healthcare policy

- LATHA JISHNU

THERE WAS a triumphal note as media across the country reported the rejection of Johnson & Johnson's claim for a secondary patent on its tuberculosis drug bedaquiline. It was big news in March when the Indian Patent Office rejected the claim, because bedaquiline is the most efficacious in treating life-threatening cases of drug-resistant TB. It is a medicine that is taken orally, has fewer of the lethal side effects of the older line of drugs and is desperately sought by patients. As a country that is burdened with the largest number of TB cases, and carries an additional load of more than a quarter of the world's drug-resistant cases, India badly needs access to generics medicines that are FEAT inexpensive and available in sufficient quantities. Bedaquiline, a patented medicine made by J&Jowned Janssen Pharmaceuticals, is neither. It is costly and hard to come by.

The original patent on bedaquiline expires in July this year, but J&J had sought to extend its monopoly with a patent for a fumarate salt version of the TB medicine. The claim was opposed in 2019 by two TB patient-activists, Nandita Venkatesan of Mumbai and Phumeza Tisile of South Africa, who were supported by humanitarian organisation Médecins Sans Frontières. The Patent Office upheld their challenge since India's law, specifically Section 3d, does not permit the patenting of incremental improvements on an existing drug unless there is proven improvement in efficacy. The rejection of the secondary patent on bedaquiline means the original patent expiry term stands, allowing generic versions to come into the market in a few months' time. The generic drugs are expected to cut costs as they generally do. J&J charges 27,000 for the prescribed six-month treatment.

There is hope, too, of supplies increasing significantly in the near future as reports talk of some companies launching their generic versions as early as August.