Tuesday, May 21, 2024

Business Matters | Why India rejected patent extension for J&J’s TB drug

Why India rejected patent extension for J&J’s TB drug

The Indian Patent Office last week rejected Johnson & Johnson’s application to extend its patent on Bedaquiline, a drug used to treat Tuberculosis.  Before we go into the details, a tiny bit of medical knowledge first. 

Tuberculosis is caused by a bacterium called  mycobacterium tuberculosis. It typically infects the lung, but can attack any other part of the body – such as kidney or the spine. Not everyone who is infected by the bacteria may fall sick. So you will have carriers of the bacteria who show no signs of illness and those that actually have TB disease. If not treated properly and in time, TB disease can be fatal. 

Among the biggest challenges to TB treatment worldwide but certainly in India is the regularity with which patients need to take their medicines but do not. And why don’t they? Reasons range from callousness to awareness of govt. facilitated availability of medicines. The bigger problem is, if the dosage of 6 months – doctors sometimes seek to treat for one whole year – is not faithfully completed, TB can attack the patient again and this time, it becomes even more difficult to treat as it could become resistant to the first line of drugs used in its treatment. Drugs like bedaquiline form the second line of treatment. 

Why was J&J’s application rejected? 

J&J had applied for ‘formulation patent’ on fumarate salt (a formulation salt of Bedaquiline), but the patent office ruled that that the salt fails to qualify as a novelty. The petitioners contended that the “salt form of a compound is not patentable in India” under Sec 3 (d) of the Indian Patents Act. The Act says that a patent cannot be granted to ‘a mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.’ Sec 3 (d) is seen as a crucial section that helps prevent ‘evergreening’ of patents.

Is there a precedent? What impact could the ruling have?

Script and presentation: K. Bharat Kumar

Production: Shikha Kumari, Shibu Narayan

Videography: Johan Sathyadas

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