In one of the most-watched patent cases in recent times, the Indian Patent Office on Thursday rejected American giant Johnson & Johnson’s (J&J) attempt to extend its monopoly on life-saving TB drug bedaquiline beyond July this year.
The development made public coincidentally on the eve of the World TB Day — will improve access to the core drug, Bedaquiline, which is part of the WHO recommended all-oral TB regimen.
Importantly, it paves the way for the entry of cheaper generics by domestic companies including Lupin and Macleods, experts told TOI.
The “landmark” decision comes a decade after Swiss MNC Novartis lost patent protection for its blockbuster cancer drug, Glivec, on a similar provision that it lacks inventive step and violates an important health safeguard. This provision, contained in Section 3(d) of the patent law prevents “evergreening”, and prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance (drug).
Regarding the case, Latika Dawara, assistant controller of patents & designs, Patent Office Mumbai said, “…Therefore, the grounds of obviousness/lack of inventive step (corresponds to section 25(1)(e) of the Act) and non-patentability u/s 3(d) & 3(e) of the Act (corresponds to section 25(1)(f)) the Act are established by the opponents.”
The decision came on a pre-grant opposition filed in 2019 by two TB survivors, Nandita Venkatesan and Phumeza Tisile, supported by Medecins Sans Frontieres (MSF). Leena Menghaney, global IP advisor for MSF’s Access Campaign said, “This is a seminal decision taken by one of the countries in the world most affected by TB. It is high time that we have alternate manufacturers supplying bedaquiline at lower prices, especially as the scale-up of the all-oral, shorter, six-month drug-resistant TB regimens by TB programmes is being planned across the world”.
When contacted a J&J spokesperson said: “The patent application in question – for a formulation of bedaquiline – was filed in India over a decade ago, as part of standard procedures when developing new medicines. Whether this patent was granted or not, a formulation patent would not have prevented generic manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023, when our API patent expires in India”.
Janssen, a subsidiary of J&J, has filed for multiple patents on bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake claims on routine improvements, a patent expert said.
Editor: IPR Daily-Ann