Bedaquiline patent win is a half victory

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 inexpensive and available in sufficient quantities. Bedaquiline, a patented medicine made by J&J-owned 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 Rs 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.

However, the Patent Office rejection needs to be seen in perspective. What it does is reaffirm the criticality of Section 3d, a highly contested provision that Big Pharma has challenged since the law was passed in 2005. But analysts have also cautioned that courts have often overturned many such decisions by the patent controller.

On the other hand, if J&J stands by the promise of its Janssen India chief that generic companies would be free to make its TB drug in 2023 after the expiry of the original patent, then perhaps we have little to worry about. In fact, bedaquiline could turn out to be a sideshow to the main battle over ways to control the crisis of India’s TB overload.

The deeper concern pertains to another drug, delamanid, which is vital for treating multiple drug-resistant and extensively drug-resistant cases of TB. Delamanid, used in combination with bedaquiline, has been the only way to treat severe cases of drug-resistant TB. If bedaquiline is costly and scarce, delamanid is even more so. But these are the only drugs in several decades to offer hope of a non-toxic way of treating TB.

The bedaquiline case also highlights the government’s inability to come to grips with India’s TB crisis and the severity of the issues that patients face. A telling case is that of Meera Yadav who, some five years ago, was battling end-stage TB and appalling personal problems since her family had thrown her out of her home and separated her from her young child. She had become hearing impaired and lost a lung as it had collapsed due to TB. The only drugs that helped her condition were a combination of bedaquiline and delamanid, medicines which were out of reach of even the Union health ministry. Depending on donations, the government was unable to provide adequate supplies of the drugs and rationed whatever supplies it could wheedle from the manufacturers. It was caught short when companies stopped donations, forcing it buy limited quantities from the market.

Delamanid, in particular, was a challenge since it was much more expensive than bedaquiline, costing around Rs 91,400 for a six-month course, and almost impossible to source. Manufactured by Japanese multinational Otsuka Pharmaceutical Factory, the drug was hard to secure, with several rounds of negotiations with the Indian subsidiary of the company proving fruitless. That’s when Yadav filed a landmark public interest petition in 2020 asking the courts to act on the government’s inability to provide life-saving medicines to drug-resistant patients.

The petition sought the court’s intervention to direct the central government to issue the necessary writs or directives to the relevant ministries for manufacture of bedaquiline and delamanid under the compulsory licence route. The Patents Act facilitates this through several sections and Yadav’s prayer was that the government should issue writs under Section 92 and/or issue authorisation for the use of the said patents under Section 100 of the law, to combat the rising number of MDR and other drug-resistant TB patients which, she said, were posing a health emergency in the country.

Nothing much has come of the petition, although the court had asked the government to respond to the petitioner’s plea. India’s marked reluctance to use CLs to provide life-saving medicines in a health emergency is well-known and is in deference to the diktats of developed countries who insist on a strict adherence to patent rules to protect their drug companies. But the Narendra Modi regime’s timidity contravenes the spirit and substance of the country’s patent law, which was formulated after much debate in parliament and outside to protect both patent owners and public health. As India girds up for one of its toughest health challenges, it will face more complex decisions on patents and public health.

It will need to show skill and strength in balancing conflicting demands. A quick scan reveals that Otsuka holds about nine patents on delamanid, of which five have been granted in India. Another two appear to be pending, while there is no information on the remaining two. More daunting is the fact that these patents are valid for the most part till 2026, while one will remain in force till 2031. Delamanid has not come into public focus yet. The main reason could be that fewer patients may be requiring the combination therapy. The number of MDR and XDR patients constitute just about 10 per cent of the total TB incidence in the country, which the World Health Organization’s "Global TB Report 2022" puts at 2.95 million. But their number could increase dramatically as TB patients like Yadav find that bedaqueline alone does not work for them.

Bedaquiline and delamanid must be made available to all patients who need it. The world is watching how India does it.