AstraZeneca, the Swedish company behind the diabetes drug Dapagliflozin (sold as Forxiga), sued eight Indian generic drug makers — Intas, Alkem, Zydus, Eris, USV, Torrent, MSN, Micro Labs and Ajanta — for selling cheaper versions of the same medicine. AstraZeneca claimed the generics infringed two Indian patents: an earlier broad “genus” patent (IN 147, which covered a large family of similar compounds and expired in October 2020) and a later “species” patent (IN 625) that specifically protected Dapagliflozin until 2023. The generic companies argued that the specific patent was invalid because Dapagliflozin was already covered and known from the first patent, making the second one obvious and not truly new. Two single judges, after hearing the cases separately, refused to stop the generics from selling their versions while the trials continued, saying the companies had raised serious doubts about the later patent’s validity. AstraZeneca appealed all nine cases together to the division bench. The Delhi High Court examined the patents, the companies’ own earlier statements in India and the US, and the scientific details. It found that AstraZeneca itself had treated Dapagliflozin as covered by the first patent, creating a credible challenge to the second patent on grounds of prior disclosure, obviousness and incomplete information given to the Indian Patent Office. The judges also noted that generics offered the medicine at much lower prices and that stopping them would harm patients more than it would help AstraZeneca. The court dismissed all the appeals on 20 July 2021, allowing the generic companies to continue making and selling Dapagliflozin while the main trials go on.
AstraZeneca AB Vs Intas Pharmaceuticals Ltd.:20.07.2021:FAO(OS)(COMM) 139/2020: Justice Rajiv Sahai Endlaw and Justice Amit Bansal.
