Draft Examination Guidelines for Pharmaceutical and Biotechnology Patents

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On 4 September 2026, the Indian Patent Office released two important draft examination guidelines:

1. Draft Guidelines for Examination of Pharmaceutical Applications for Patent; and

2. Draft Guidelines for Examination of Biotechnology Applications for Patent.

These drafts update older sector-specific guidance—the pharmaceutical guidelines dating from 2014 and biotechnology guidelines from 2013—and seek to reflect developments in technology and more recent Indian patent jurisprudence.

Pharmaceutical Applications

The draft pharmaceutical guidelines reportedly provide updated guidance concerning important examination issues including:

• Novelty;

• Inventive step;

• Markush claims;

• Pharmaceutical compositions and related subject matter; and

• The application of Section 3(d) and the requirement concerning therapeutic efficacy in appropriate cases.

The incorporation of more recent judicial developments is particularly relevant because pharmaceutical patent prosecution in India frequently involves complex questions concerning incremental innovations, new forms of known substances, formulations and therapeutic effects.

For pharmaceutical applicants, the developments reinforce the importance of carefully establishing the technical contribution and supporting the claimed invention through the specification and appropriate experimental evidence.

Biotechnology Applications

The draft biotechnology guidelines similarly update the earlier 2013 guidance and take account of developments in biotechnology, including technologies such as:

• CRISPR-Cas9 gene editing;

• Bioinformatics;

• Synthetic biology; and

• Other emerging biotechnology techniques.

The draft also updates examination terminology, search resources and guidance concerning biodiversity-related compliance.

This is particularly relevant to biotechnology, pharmaceutical, diagnostics, agricultural biotechnology and life-sciences companies whose inventions may involve biological materials, genetic technologies or complex biological processes.

Why these developments matter

The release of dedicated pharmaceutical and biotechnology guidelines indicates an effort to make examination practice more technology-specific and predictable.

For applicants, this may make it increasingly important to consider Indian examination requirements at the drafting stage, rather than addressing them only after receipt of an FER.

Our view: Companies with pharmaceutical and biotechnology portfolios should closely monitor the final guidelines and consider whether their India filing and prosecution strategies should be adjusted once the final versions are issued.