World TB Day coincides with the Indian Patent Office rejecting J&J’s application to extend its patent on anti-tuberculosis drug Bedaquiline

The extension was sought by Johnson & Johnson for the primary patent on a vital anti-tuberculosis drug Bedaquiline beyond its expiry in July 2023.

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TODAY marks World Tuberculosis (TB) Day, dedicated to building awareness about the global epidemic of TB and efforts to eliminate the disease. According to the Press Information Bureau, the World Health Organisation Global TB Report of 2022 states that 1.4 lakh TB cases were notified in India in 2021, 18 per cent higher than in 2020.

World TB Day coincides with the Indian Patent Office rejecting the USA pharmaceutical corporation Johnson and Johnson's (J&J) application on Thursday to extend its patent on the vital anti-TB drug Bedaquiline. The extension was sought for the primary patent on Bedaquiline beyond its expiry in July 2023. To date, J&J had a monopoly on manufacturing the Bedaquiline compound.

Bedaquiline is used for the treatment of multi-drug resistant TB patients for whom the first line of drug treatment has failed. The rejection of J&J's patent extension will allow generic drug manufacturers, including Lupin and Macleods, to produce their own versions of Bedaquiline at affordable prices, leading to its wider access.

Reportedly, several Indian manufacturers are ready to supply the generic version. It is estimated that with treatment scale-up and competition among generic manufacturers to begin by July 2023, the price of Bedaquiline could soon come down by as much as 80 per cent.

According to the estimates provided by The Times of India, in 2019, over 55,000 patients could have benefited from access to Bedaquiline. However, as of March 2020, only around 10,000 of these patients were able to access the drug.

In the order, Latika Dawara, Assistant Controller of Patents and Designs, noted that J&J's application failed to meet the requirements of Sections 2(1)(ja), and 3(d) and 3(e) of the Patents Act, 1970. The application for extension under Section 15 of the Patents Act was rejected.

The order is the consequence of a petition filed by two TB survivors, Nandita Venkatesan and Phumeza Tisile, at the Mumbai Patent Office in 2019.

The Hindu has reported that in the order, Dawara has stated that the invention claimed was obvious and therefore non-patentable since it failed to involve any inventive steps. The order further noted that the claimed compounds by J&J are mere admixtures or aggregations of properties, and thus, not amounting to a new invention under Section 3(e) of the Patents Act.

As reported by The Economic Times, J&J had filed a patent application for the fumarate salt (a formulation) of Bedaquiline in 2008 to extend its patent till 2027, which was under review by the patent office. J&J had filed multiple applications for secondary patents on Bedaquiline in India and in many other countries.

Further, reportedly, J&J was involved in a strategy called 'evergreening' that is used by pharmaceutical companies to extend the period of patents about to expire by making claims in their applications for patent extensions, thereby keeping the prices high. The strategy is meant to keep the cheaper generic versions of the drug out of the market.

In March 2021, the Bombay High Court directed the Union government to pass an order on a representation asking it for 'compulsory licenses' to import two patented life-saving anti-TB drugs – Bedaquiline and Delamanid – to enable alternate producers to offer more affordable generic versions of the drug to the National TB Elimination Programme at a far lower price.

Senior advocate Anand Grover, for the petitioners, argued that India had the largest number of people affected by TB, specifically by multidrug-resistant TB and extensively drug-resistant TB.