Patent Monopoly/Evergreening

Facts for Prelims
 

Patent Monopoly/Evergreening
 

News: India rejects Johnson & Johnson’s attempt to extend monopoly on lifesaving TB drug – Bedaquiline.
 

What is Evergreening?
 It is a practice of modifying drugs (without improving efficacy) in order to extend their patent life and profitability.
 Evergreening establishes monopoly and it undermines competition.
 The Indian Patents Act, 1970 prohibits the mischievous practice of evergreening of patents making the drugs affordable and promoting domestic generic drug markers.
 

About Bedaquiline:
 Bedaquiline is a crucial drug in the treatment of multi-drug resistant TB patients for whom the first-line drug treatment (Isoniazid, Rifampicin, Pyrazinamide and Ethambutol) has stopped working.
 Over 55,000 patients benefited from access to Bedaquiline in India in 2019.
 When J&J filed for evergreening of its patent on fumarate salt (a formulation of Bedaquiline), its patent evergreening practice was challenged by two TB survivors in 2019.