The Indian Patent Office has rejected the attempt of Johnson & Johnson to extend its patent (which expires this July) on its anti-tuberculosis drug, Bedaquiline. In doing so, the Patent Office has invoked Section 3 (d) of the Indian Patents Act which debars the patenting of a “mere use of a known method” unless it results in a new product or employs at least one new reactant — in other words, it forbids evergreening a patent just as it is about to expire. The order echoes the Supreme Court’s watershed ruling in April 2013 against Novartis. The apex court invoked Section 3 (d) to strike down Novartis’ attempt to “evergreen” its patent on its anti-cancer drug Glivec. In the Bedaquiline case, J&J had years ago applied for a ‘formulation patent’ on fumarate salt (a formulation salt of Bedaquiline), which failed to qualify as a novelty.
The petitioners argued that the “salt form of a compound is not patentable in India” under Section 3 (d). China too has rejected this patent appeal on bedaquiline fumarate salt, while it is a subject of dispute in Thailand and Brazil. A host of African countries have, however, granted the product and process patent. The implications of this order are favourable for a number of multi-drug resistant TB patients (DR-TB) in particular, for whom this medicine is currently priced at $400 for a six-month dose.
The immediate implications of the ruling are that on the expiry of the patent in another four months, generic drug makers such as Lupin and Mcleods can produce and sell the same. While J&J has argued that this would have held true even if their formulation patent had been upheld, this is not strictly true. The company would arguably have the option to use the process patent as a legal entry barrier. Off-patent Bedaquiline prices are expected to fall to about $50 for a six-month dose if not more. India has about 2.1 million active TB cases and about 80,000 die every year; 5 per cent of these patients could have DR-TB. This order could be a life-saver.
India’s Patent Office must exercise similar rigour in the public interest, and to this end should be equipped with qualified staff. But where the patent is not in dispute and the medicine is of a life-saving nature, Indian companies should come forward to invoke compulsory licences (CL). However, they tend to prefer the voluntary licence route, as was evident in the case of the sale of Remdesivir in Covid times. CLs could lead to friction between the foreign entity and its Indian counterpart, even as the prices are capped at reasonable levels. The Centre’s softpedalling on CLs was understandable during Covid times when it perhaps feared that invoking rights under TRIPS would have disrupted global coordination efforts. But now, it can use its G-20 presidency to push the envelope. Breast cancer medicines manufactured by Novartis, Pfizer and Lilly cost ₹50,000-1,00,000 a month. Treatment for cystic fibrosis is similarly unaffordable. A CL thrust would help lakhs of people.
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