It is often observed after a high-profile refusal of a cancer drug patent in India that the country is unusually hard on pharmaceutical patenting. Applicants, students, and R&D teams then ask a predictable follow-up: is India simply anti-patent, or is there a principled framework behind these outcomes? The reality is that India’s system sets a higher bar for certain pharma claims, backed by specific statutory provisions and court-driven tests, and it couples that bar with robust opposition and access-oriented remedies. Understanding this architecture helps in planning filings and in building the right evidence at the right time.
The statutory architecture, in one line
India’s Patents Act lists what are not inventions under Section 3. Three clauses shape pharma practice most: Section 3(d) on new forms of known substances that lack enhanced efficacy, Section 3(e) on mere admixtures without synergy, and Section 3(i) on methods of treatment and diagnosis. The explanation to Section 3(d) expressly names salts, esters, polymorphs, metabolites, and similar derivatives, signalling special scrutiny of incremental pharmaceutical claims.
Section 3(d), evergreening, and the “therapeutic efficacy” test
The Supreme Court’s decision in Novartis AG v. Union of India (2013, SC) is the lodestar. The Court held that Section 3(d) sets a second-tier threshold for chemical and pharmaceutical substances, and that “efficacy” in this context means therapeutic efficacy. Merely showing improved physico-chemical properties such as better bioavailability, stability, or flow does not suffice unless there is a proven enhancement in therapeutic effect. This case anchors India’s stance against evergreening and requires comparative data that persuades on therapeutic outcomes.
Courts have reiterated this higher bar. A 2024 decision of the Delhi High Court, while dealing with a pharma dispute, expressly restated that Section 3(d) imposes a supra standard in addition to novelty and inventive step, aimed especially at medicines. This is a useful reminder that even at the interim stage, pharma patents invite a closer look for 3(d) compliance.
Applicant takeaway: if you claim a new form, new crystal, or a dosage form of a known substance, assemble comparative therapeutic data that ties improvements to clinical benefit, not just to lab convenience or pharmacokinetic advantages.
Section 3(e) and the synergy requirement for compositions
Formulation and combination claims face Section 3(e) where the invention is a substance obtained by a mere admixture. The test is whether the components together yield a synergistic effect, not a simple aggregation of individual properties. The Patent Office’s Pharmaceutical Examination Guidelines (2014) instruct Examiners to insist on comparative, well-designed data demonstrating synergy, ideally placed in the specification from the start.
A notable illustration is Ajanta Pharma Ltd. v. Allergan Inc. (IPAB, 2013), where combination therapy claims were evaluated with specific focus on synergy evidence. The ratio emerging from this line is straightforward: formulations or FDCs that only add known effects will struggle, while those showing an unforeseen, quantifiable uplift can pass 3(e).
Applicant takeaway: plan head-to-head studies that isolate the combination’s effect beyond the sum of parts, for the very endpoints your claim promises.
Section 3(i), methods of treatment and diagnostics
India excludes methods of treatment and diagnostic methods practiced on the human or animal body. Recent cases show careful boundary-setting. In Arthrogen GmbH v. Controller General of Patents (Delhi HC, 2024), the Court held that a method of producing a protein-enriched serum was not a treatment method per se, emphasising that exclusions bite when the claim itself is to treatment or diagnosis, not when it is to making a product. The ratio helps applicants frame around the exclusion.
Applicant takeaway: keep claims on the product, kit, composition, or device, and avoid language that reads like a clinical protocol. Where a step could be read as diagnosis or therapy, re-draft to a manufacture or measurement focus.
The process is as important as the statute
Robust oppositions keep the bar high
India provides pre-grant opposition to “any person” and post-grant opposition to persons interested, which means pharma applications often meet adversarial testing before and after grant. This procedural openness contributes to the perception of strictness, but it also improves the quality of grants.
Examiner playbooks integrate court guidance
The Pharmaceutical Examination Guidelines (2014) synthesise court reasoning on Sections 3(d), 3(e) and 3(i), and encourage Examiners to ask for real-world data rather than accept assertions. Applicants who mirror this structure in their specifications and claim drafting experience smoother prosecution.
Enforcement has its own filters, especially in pharma
Even when a pharma patent survives Section 3 and prior art, injunctions are not automatic. In the long-running Roche v. Cipla dispute over erlotinib, the Delhi High Court ultimately upheld validity and found infringement, but the enforcement journey reflected the judiciary’s repeated weighing of public interest and price-access dimensions while considering interim relief. This shapes litigation strategy in India and reinforces the need for clear technical strength on patentability.
Access safeguards in the backdrop, notably compulsory licensing
India’s first modern compulsory licence, for sorafenib in Bayer v. Natco, was granted by the Controller in 2012, upheld by the IPAB in 2013 and by the Bombay High Court in 2014, with the Supreme Court declining to interfere. While compulsory licences are rare, the precedent underscores that pricing, reasonable requirements of the public, and domestic working can be determinative in exceptional cases. This backdrop reinforces the system’s access orientation, especially for life-saving medicines.
Practical playbook for pharma applicants
1) Build the right data early
For Section 3(d) issues, target endpoints that relate to therapeutic efficacy. Link improved PK or stability to a clinical outcome, and explain the mechanism that plausibly drives efficacy.
For Section 3(e), design studies that isolate the interaction effect. Use factorial designs or isobolograms where relevant, and show a statistically meaningful uplift over both individual actives and simple sums.
2) Draft for Indian exclusions
Prefer product, composition, kit, or device claims over treatment or diagnostic method claims to steer clear of Section 3(i). Where borderline, recast to manufacturing or measurement features, learning from Arthrogen.
3) Anticipate opposition
Map likely opponents and pre-empt their 3(d)/3(e) arguments in the specification. A clear problem–solution narrative, supported by comparative data, reduces room for attack under Section 3 and inventive step.
4) Enforcement strategy
If litigation is expected, ensure prosecution history and expert evidence align with your efficacy and synergy positions. Be prepared for courts to weigh public interest when seeking interim relief in drug cases.
