Why India rejected patent extension for J&J’s TB drug
The Indian Patent Office final week rejected Johnson & Johnson’s software to increase its patent on Bedaquiline, a drug used to deal with Tuberculosis. Before we go into the main points, a tiny little bit of medical data first.
Tuberculosis is attributable to a bacterium known as mycobacterium tuberculosis. It usually infects the lung, however can assault another a part of the physique – akin to kidney or the backbone. Not everybody who’s contaminated by the micro organism might fall sick. So you’ll have carriers of the micro organism who present no indicators of sickness and people who even have TB illness. If not handled correctly and in time, TB illness may be deadly.
Among the largest challenges to TB remedy worldwide however definitely in India is the regularity with which sufferers have to take their medicines however don’t. And why don’t they? Reasons vary from callousness to consciousness of govt. facilitated availability of medicines. The greater downside is, if the dosage of 6 months – medical doctors typically search to deal with for one entire yr – will not be faithfully accomplished, TB can assault the affected person once more and this time, it turns into much more troublesome to deal with because it might grow to be immune to the primary line of medicine utilized in its remedy. Drugs like bedaquiline kind the second line of remedy.
Why was J&J’s software rejected?
J&J had utilized for ‘formulation patent’ on fumarate salt (a formulation salt of Bedaquiline), however the patent workplace dominated 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” underneath Sec 3 (d) of the Indian Patents Act. The Act says {that a} patent can’t 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 an important part that helps stop ‘evergreening’ of patents.
Is there a precedent? What affect might the ruling have?
Script and presentation: Ok. Bharat Kumar
Production: Shikha Kumari, Shibu Narayan
Videography: Johan Sathyadas
