In one of the maximum-watched patent instances in latest times, the Indian Patent Office on Thursday rejected American massive Johnson & Johnson`s (J&J) try and enlarge its monopoly on life-saving TB drug bedaquiline past July this year.
The improvement made public coincidentally at the eve of the World TB Day — will enhance get entry to to the center drug, Bedaquiline, that's a part of the WHO advocated all-oral TB regimen.
Importantly, it paves the manner for the access of inexpensive generics via way of means of home organizations which includes Lupin and Macleods, professionals advised TOI.
The “landmark” selection comes a decade after Swiss MNC Novartis misplaced patent safety for its blockbuster most cancers drug, Glivec, on a comparable provision that it lacks resourceful step and violates an crucial fitness safeguard. This provision, contained in Section 3(d) of the patent regulation prevents “evergreening”, and prohibits provide of patents to new types of regarded substances, until the brand new shape consequences in superior efficacy over the regarded substance (drug).
Regarding the case, Latika Dawara, assistant controller of patents & designs, Patent Office Mumbai said, “…Therefore, the grounds of obviousness/loss of resourceful step (corresponds to segment 25(1)(e) of the Act) and non-patentability u/s 3(d) & 3(e) of the Act (corresponds to segment 25(1)(f)) the Act are mounted via way of means of the opponents.”
The selection got here on a pre-provide competition filed in 2019 via way of means of TB survivors, Nandita Venkatesan and Phumeza Tisile, supported via way of means of Medecins Sans Frontieres (MSF). Leena Menghaney, worldwide IP marketing consultant for MSF`s Access Campaign said, “This is a seminal selection taken via way of means of one of the international locations withinside the global maximum laid low with TB. It is excessive time that we've exchange producers providing bedaquiline at decrease prices, specially because the scale-up of the all-oral, shorter, six-month drug-resistant TB regimens via way of means of TB programmes is being deliberate throughout the global”.
When contacted a J&J spokesperson said: “The patent utility in question – for a method of bedaquiline – changed into filed in India over a decade ago, as a part of general tactics whilst growing new medicines. Whether this patent changed into granted or now no longer, a method patent could now no longer have avoided standard producers from growing the lively pharmaceutical ingredient (API) of their very own formulations after July 2023, whilst our API patent expires in India”.
Janssen, a subsidiary of J&J, has filed for a couple of patents on bedaquiline in India, now no longer proscribing itself to the simple compound patent however additionally submitting secondary patents to stake claims on habitual improvements, a patent professional said.
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