India's Patent Office has published the Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology, 2026, replacing guidance that dates back to 2013. The draft brings 13 years of statutory amendments, administrative directives, and case law into day-to-day examination practice. For U.S. filers, the stakes are concrete: claims drafted for the USPTO will now be tested against India's distinct rules on diagnostics, efficacy, enablement, and disclosure. Those rules can reward some U.S.-style claims and sink others. Because the draft limits claim amendments to disclaimers, corrections, or explanations, the claim set and supporting data that enter India in the Patent Cooperation Treaty (PCT) national phase largely set the ceiling on what can be obtained. That makes the period before national-phase entry the critical moment to restructure claims for India: lead with kit and device claims where diagnostic method claims face risk, line up comparative efficacy data for Section 3(d), narrow broad sequence-identity ranges to what the examples support, and remove claims that fall within India's moral exclusions. Waiting for the First Examination Report may be too late.

Diagnostics: More Room in India Than at Home

Diagnostics are among the most notable areas for U.S. practitioners. The draft narrows India's Section 3(i) "diagnostic" exclusion to processes that inherently disclose pathology for human medical treatment. It also confirms that diagnostic products, kits, devices, and screening tools are patent-eligible. In the U.S., Mayo and Myriad have made diagnostic method claims hard to secure. Indian prosecution, especially for kit and device claims, may therefore deserve fresh attention rather than being treated as an afterthought.

Section 3(d): Data Still Drives Outcomes

India's well-known efficacy requirement has not gone away. The draft states that non-therapeutic enzyme variants fall under Section 3(d) and must show a material enhancement of efficacy. It also confirms that enhanced bioavailability alone does not prove therapeutic efficacy. There is a helpful procedural point as well: examiners must identify the specific known substance when they raise a Section 3(d) objection. U.S. applicants should plan comparative efficacy data early, ideally before the PCT national-phase deadline.

Enablement Rules That Echo Amgen

U.S. practitioners will recognize the theme after Amgen v. Sanofi. A new illustrative example, IE-33, sets strict requirements for experimental data supporting broad sequence-identity ranges, such as 80% identity, in antibody CDRs. The draft also reinforces enablement requirements for broad claims. It limits claim amendments to disclaimers, corrections, or explanations. Because amendments are this narrow, fallback positions must already be in the specification as filed.

Bioinformatics

For AI-driven biomarker inventions, IE-34 requires full disclosure of neural network architectures, feature extraction models, and training methods. Computational genomics methods without a tangible technical application remain excluded under Section 3(k). Applicants who keep model details confidential as trade secrets in the U.S. may face a real disclosure trade-off in India.

Practical Compliance Points

• Sequence listings must comply with WIPO ST.26 in XML.
• India now has a third recognized Budapest depository, NAIMCC in Mau, Uttar Pradesh.
• Failing to disclose biological source or origin, or disclosing it wrongly, remains a ground for pre- and post-grant opposition.
• Examiners will be directed to disclose their complete prior-art search strings in the First Examination Report. This gives applicants useful insight when they respond.

Moral Exclusions

New examples bar claims involving human embryo destruction and CRISPR human germline editing for genetic enhancement. The U.S. has no comparable statutory bar, so claim sets may need to be tailored for India.

Looking Ahead

The public comment period closed on Sept.19. The final guidelines may still change. Even so, the direction is clear: India is becoming more receptive to diagnostics and modern biotech platforms while requiring strong data and full disclosure. U.S. applicants should review pending Indian biotech filings and draft new specifications with these standards in mind.