Tag Archives: Biomedicines

Data Exclusivity Drug Regulation Patent

Delhi HC Imposes Strict Conditions on the Sale of Biomedicines: Part 1/2


In an order that is likely to have wide-ranging ramifications on the biomedicine industry, the Delhi High Court on Monday (25th April) imposed some conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. The decision, clocking in at 227 pages, discusses a number of profoundly important issues such as data exclusivity, patent linkage, norms to be followed for patient safety and the rights of patentees after the expiry of their patent….


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