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In a defeat for Johnson & Johnson, the Indian patent office has rejected its bid to extend a monopoly on a crucial tuberculosis treatment, opening the door to lower-cost generic alternatives needed in low- and middle-income countries.

The health care giant sought to extend patent protection on bedaquiline, also known as Sirturo, after the primary patent expires in India in July. The move angered advocacy groups, because the medicine is considered the backbone in treatment regimens and accounts for anywhere from 35% to 70% of the overall cost. Advocates estimate generic versions could lower costs by as much as 80%.


With help from various groups, two tuberculosis patients challenged the patents, arguing that J&J had not made substantial improvements to its medicine. Rather, they argue, the company made minor changes that did not warrant an extension. This practice, known in the patent world as evergreening, is prohibited in India, which famously rejected a similar move by Novartis involving a cancer drug a decade ago.

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