- The Indian Patent Office has rejected U.S. pharmaceutical giant Johnson & Johnson’s (J&J) attempt to extend its monopoly on the manufacturing of the anti-tuberculosis drug Bedaquiline in India beyond July 2023.
- The patent office invoked Section 3(d) in its judgment as the Indian patent law does not allow the evergreening of patents and prevents pharma majors from extending the patent beyond the stipulated monopoly on the drug.
- J&J’s primary patents on Bedaquiline expire in July, paving the way for generic drug manufacturers such as Lupin and Macleods, among others, to produce Bedaquiline, thus ensuring cheaper and wider access to the drug. Currently, Bedaquiline tablets are priced at $400 per six-month treatment course.
- Bedaquiline is a crucial drug in the treatment of multi-drug resistant TB patients for whom the first-line drug treatment — using Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol — has stopped working.
Evergreening of Patents:-
- The evergreening of patents is a practice of tweaking drugs in order to extend their patent term and thus their profitability.
- The Indian Patents Act 1970 introduced many provisions [Sections 3(d), 53(4), and 107A] to prevent the mischievous practice of “evergreening” of patents.
- This is to aid millions of people who can’t afford the expensive modified drugs, as well as the development of the domestic generic drug market.
- However, evergreening patents on drugs (diabetes, cancers, cardiovascular diseases, etc) continue to be granted to pharmaceutical innovator companies by the Indian Patent Office and enforced through courts.
