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Showing posts with the label NBA Approval timing

Critical Analysis: Intra-Cellular Therapies, Inc. v. Controller of Patents

  Critical Analysis: Intra-Cellular Therapies, Inc. v. Controller of Patents (2026:DHC:5394) C.A.(COMM.IPD-PAT) 24/2023 | Delhi High Court | Decided: 06.07.2026 I. Doctrinal Analysis: Novelty and the "Coverage vs. Disclosure" Question A. The genus-species anticipation problem The core novelty dispute was a classic Markush-genus-versus-species-selection issue. The appellant argued that arriving at the claimed species from the generic Formula I of D1/D7 required " multiple selections " among independent variables (R1–R6), and that the Controller impermissibly relied on more than one prior art document to construct a single "closest prior art" novelty attack — a submission with real doctrinal pedigree, since novelty (unlike obviousness) is ordinarily tested against a single prior document read as a whole. The Court's response — invoking AstraZeneca AB and Boehringer Ingelheim v. Vee Excel — collapses the " covered vs. disclosed " dist...

Delhi HC Clarifies NBA Approval Timing in Patent–Biodiversity Interface

ABSTRACT  —  In a significant decision touching the intersection of patent law and biodiversity legislation, the Delhi High Court set aside the Controller of Patents’ order refusing an herbal pain-killer patent application on the ground that the applicant had not yet produced National Biodiversity Authority (NBA) approval at the time of hearing. The Court held that the proper course was to defer the final order until the approval was received, not to refuse outright—particularly where the invention had been found novel on merits. The judgment clarifies the timing requirements under the Biological Diversity Act, 2002 vis-à-vis the Patents Act, 1970, and reinforces the Controller’s duty to exercise discretion humanely and purposively. I.  Introduction The grant of a patent for an invention based on, or derived from, biological material sourced from India is conditional upon compliance with the Biological Diversity Act, 2002 (‘BD Act’). The Patents Act, 1970 (‘PA’) gives...