Explore the misapplication of Section 3(e) of the Indian Patents Act—why “mere admixture” rejections often go wrong, judicial clarifications (including Oramed Ltd. v. Controller General, 2025), and strategies to overcome objections in pharma, chemical, and biotech patents.

The Complexity of Section 3(e)

Section 3 of the Indian Patents Act, 1970 outlines non-patentable subject matter, and within it, Section 3(e) specifically bars:

“a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance.”

This provision is designed to exclude from patentability those compositions that are mere combinations, lacking any synergistic effect.

While the intent is to prevent trivial inventions from receiving monopolies, misapplication of this provision—particularly in pharmaceutical, nutraceutical, and formulation-related patents—has led to arbitrary rejections, undermining genuine innovations.

Legal Standard: What Section 3(e) Actually Requires

To invoke Section 3(e), the following test is applied:

• Is the claimed invention a mere admixture?

• Does it result only in the aggregation of individual component properties?

• Or, does it exhibit a synergistic effect (i.e., combined effect > sum of individual effects)?

The synergistic effect must be supported with experimental data, ideally comparative data between individual components and the claimed mixture.

Section 3(e): Scope of Composition Claims

Novozymes v. Assistant Controller (2023)

• The court interpreted Section 3(e) broadly, holding that the provision is not limited to compositions of known ingredients, nor to independent claims alone.

• Composition claims—even those incorporating novel elements—must demonstrate synergistic properties, not mere aggregation.

Common Misapplications of Section 3(e)

Despite the established legal threshold, several Controllers at the IPO have misapplied Section 3(e) in the following ways:

1. Conflating Section 3(e) with Section 3(d)

Unlike Section 3(e), Section 3(d) is applicable to both pharmaceutical and biochemical inventions, requiring reasonable enhancement of efficacy—not necessarily numeric thresholds. The Madras High Court reaffirmed this in Novozymes v. Assistant Controller (2023)

2. Ignoring Experimental Data or Expert Affidavits

Applicants often file:

• In vitro/in vivo studies showing combined pharmacokinetic advantage,

• Formulation test results,

• Affidavits by inventors or scientific experts.

Yet Controllers reject applications under 3(e) without discussing or analyzing this evidence.

3. Applying 3(e) Without Determining Novelty or Inventive Step First

Section 3(e) should be a supplementary ground; yet, in several rejections, it is used as the sole ground without assessing:

• Whether the composition is novel,

• Whether it involves an inventive step.

Case Spotlight: Oramed Ltd. v. Controller General (2025)

The Calcutta High Court set aside the rejection under Section 3(e) and unequivocally held:

“The Controller erred in confusing synergy under Section 3(e) with therapeutic efficacy under Section 3(d)...”

The Court also noted:

• The hearing notice cited Sections 3(e) and 2(1)(ja), but the order rejected the application based on Section 3(d)-style efficacy — a fundamental misapplication of law.

• Higher standard: for 3(e), synergy must be demonstrated; efficacy/bioavailability alone is irrelevant.

• The invention involved oral insulin with protease inhibitors, EDTA, and Omega‑3, claimed to improve stability and absorption.

The Court found these missteps substantial enough to set aside the refusal and remand the case with directions for proper re-evaluation.

What Constitutes “Synergy”? – Evidence that Works

To overcome Section 3(e), applicants should:

• Provide comparative data (each component vs. claimed combination),

• Use standard pharmacological markers (bioavailability, half-life, solubility, etc.),

• File technical affidavits by qualified professionals,

• Refer to peer-reviewed studies or clinical trial data, if applicable.

Business Impact: Why This Matters

For Pharma & Life Sciences Companies:

• Section 3(e) rejections can delay critical product launches.

• Procedural delays increase IP risk during licensing and funding rounds.

• Properly defending 3(e) objections helps in cross-border filing strategies (PCT, EP, US).

For Startups:

• Rejections under Section 3(e) are often improperly justified, discouraging early-stage innovation.

• Enforcement and commercial valuation of such patents may be weakened.

International Perspective

Countries like the US and EU do not have a similar "mere admixture" exclusion. There, inventive step is examined holistically based on the contribution of the invention.

Thus, Section 3(e) remains a uniquely Indian legal hurdle that needs precise navigation.

Conclusion:Strategize, Don’t Compromise.

Section 3(e) is a legal filter, not a catch-all rejection clause. Misapplication dilutes innovation and deters international applicants from entering the Indian market.

Applicants and patent agents must:

• Know the legal difference between Sections 3(d) and 3(e),

• Insist on proper analysis of evidence by the IPO,

• File appeals or review petitions where warranted.

FAQs on Section 3(e)

Q1: Is synergy the same as therapeutic efficacy?
👉 No. Synergy is the enhanced combined effect of ingredients. Efficacy is the improved therapeutic outcome of a drug (relevant under Section 3(d)).

Q2: Can we submit synergy data after filing?
👉 Yes, but it should support what's already disclosed in the specification.

Q3: How do I prove synergy?
👉 Use pharmacological data, in vivo studies, or comparative test results.

Q4: Is rejection under Section 3(e) final?
👉 No. You can file a review petition, divisional application, or appeal to the High Court under Section 117A.

Q5: What’s the best way to draft a claim to avoid 3(e)?
👉 Draft method/process claims demonstrating interaction, and include synergy data in the description.Would you like a visual infographic summarizing this article?