SKINNY LABELS, SECOND MEDICAL USE PATENTS AND GENERIC MARKET ENTRY: REASSESSING INDIA’S PHARMACEUTICAL PATENT AND REGULATORY FRAMEWORK

India relies on substantive patentability standards, rather than regulatory patent-management mechanisms, to govern generic entry into its pharmaceutical market. This approach distinguishes India from the two of the world’s leading pharmaceutical jurisdictions, the United States and the European Union. In the United States, patent status is directly linked to drug approval via the Orange Book and Hatch-Waxman’s carve-out procedure. The European Union and Canada, in contrast, keep patent status and drug approval formally separate, but still require public disclosure of limited information about protected indications. India separates the two regimes completely and discloses almost nothing between them. India represents a distinct model of pharmaceutical patent regulation, i.e., patent independence without patent transparency. The claim-drafting practice at the Indian Patent Office has widened the gap in the model since 2005. Formulation, combination, and polymorph patents keep bypassing examination even if direct therapeutic use claims would fail under Section 3(i). So generic manufacturers are left with no reliable way to assess their independence to operate in the market. The paper explains how the gap developed and proposes a narrow, linkage-free disclosure to close it.