India's Patent Office releases draft rules to tighten pharmaceutical and biotech patent reviews

The Indian Patent Office, operating under the Ministry of Commerce and Industry, published draft guidelines on September 4 to overhaul the examination of pharmaceutical and biotechnology patent filings. The proposal emphasizes quality, consistency and uniformity, drawing on recent judicial decisions, including the Delhi High Court’s “Seven Stambhas” test for novelty. It addresses core patentability criteria—novelty, inventive step, industrial applicability, sufficiency of disclosure—and highlights special matters such as moral, environmental and ethical issues, ESTs, stem cells and gene diagnostics.

Officials intend the rules to harmonize examiner practices across the office. Legal analyst Mohit Singh praised the draft for aligning patent examination with current court standards and improving certainty for R&D investors. The guidelines remain provisional pending final approval.