India proposes new pharma and biotech patent examination guidelines

India’s patent office has released draft examination guidelines for pharmaceutical and biotechnology patent applications, incorporating recent case law and developments in technology and patent practice.

The Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) published the Draft Guidelines for Examination of Pharmaceutical Applications for Patent and the Draft Guidelines for Examination of Biotechnology Applications for Patent on September 4, 2026.

The proposed pharmaceutical guidelines would update the existing 2014 guidance, while the biotechnology guidelines would replace the current 2013 guidance. The CGPDTM has invited stakeholders to submit comments and suggestions on both drafts within 15 days of their publication.

Pharmaceutical patent examination

The draft pharmaceutical guidelines incorporate developments in Indian patent law and jurisprudence since the existing guidance was issued.

Among the areas addressed are Markush claims, novelty and inventive step, together with the application of Section 3(d) of the Patents Act, 1970. Section 3(d) is particularly significant in pharmaceutical patent practice in India. It excludes certain new forms of known substances from patentability unless they meet the statutory requirements concerning enhanced efficacy.

The draft guidelines provide examiners with more detailed direction on the examination of pharmaceutical applications, including issues surrounding patentability and the evidence that may be relevant to particular assessments. The proposed guidance also reflects recent judicial developments, with the CGPDTM seeking to bring examination guidance into closer alignment with developments in Indian patent jurisprudence.

Biotechnology guidance reflects emerging technologies

The biotechnology draft similarly updates the Patent Office’s existing guidance to reflect technological and legal developments since the 2013 guidelines were issued.

The draft addresses newer technologies and fields including CRISPR-Cas9-based DNA editing, bioinformatics and synthetic biology. It also updates guidance concerning patent-search tools, databases, and relevant patent terminology.

Another significant area is biodiversity compliance. The draft provides updated guidance for biotechnology applications involving biological resources and related requirements, an area of particular importance in India given the country’s biodiversity legislation and requirements concerning biological material.

The proposed guidelines therefore seek to give patent examiners a more up-to-date framework for assessing applications covering technologies that were either less developed or not addressed in the same detail when the 2013 guidance was issued.

Short consultation period

The CGPDTM has given stakeholders 15 days from publication to submit comments and suggestions on the draft guidelines. The consultation provides pharmaceutical and biotechnology companies, patent attorneys, researchers and other stakeholders with an opportunity to comment before the guidelines are finalized.

The proposals come as the Indian Patent Office continues to update its examination guidance across different technology areas. In 2026, it has also published updated guidance concerning computer-related inventions and the use of artificial intelligence in patent examination procedures. For life-sciences patent owners and applicants, the pharmaceutical and biotechnology drafts are particularly significant because they address two highly specialized areas of Indian patent examination and incorporate developments in both case law and technology.

The guidelines remain in draft form and do not themselves amend India’s patent legislation. Their final scope and effect will depend on the versions ultimately adopted following the consultation process.

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