Synergistic pharmaceutical combinations of independent active agents are patentable products and not excluded methods of treatment. SUMMARY 1. Facts: The Appellant challenged an order by the Deputy Controller of Patents refusing an application for a pharmaceutical combination (Encorafenib, an EGFR inhibitor, and an optional PI3K-α inhibitor). The Patent Office rejected the application on grounds of lack of inventive step (Section 2(1)(ja)), non-patentability as a "new form of a known substance" (Section 3(d)), and for being a "method of treatment" (Section 3(i)). 2. Issues: * Whether a combination of known independent active pharmaceutical agents (APAs) constitutes a "method of treatment" under Section 3(i). * Whether Section 3(d) applies to a combination of distinct active ingredients. * Whether the combination demonstrated technical advancement over cited prior art (D1-D4). 3. Court’s Reasoning: * Section 3(i): The Court held that Claim 1 was a product claim for a "pharmaceutical combination," not a process. Functional descriptors like "simultaneous or sequential administration" describe how the product is used but do not transform a product claim into a method of treatment. Working examples in the specification demonstrate feasibility but do not define the legal scope of the claims. * Section 3(d): Following established precedent, the Court ruled that Section 3(d) typically applies to new forms/derivatives of a *single* known substance. A combination of two or more separate active drugs (each with distinct chemical identities) does not fall under Section 3(d) as they are not "derivatives" of each other. * Inventive Step: The Court found the Controller’s analysis flawed. The cited prior arts (D1-D4) did not disclose the specific combination of the claimed inhibitors. Furthermore, the clinical data provided in the specification demonstrated significant tumor regression (synergy) which was not anticipated by the prior art. 4. Conclusion: The High Court set aside the impugned order, holding the findings on Sections 3(i), 3(d), and 2(1)(ja) unsustainable. The matter was remanded to the Controller for fresh consideration on merits within six months.

The Appellant filed Indian Patent Application No. 450/DELNP/2015 for a pharmaceutical combination comprising a B-Raf inhibitor (Encorafenib), an EGFR inhibitor (Cetuximab/Erlotinib), and optionally a PI3K-alpha inhibitor (Alpelisib) for treating proliferative diseases

Despite providing clinical trial data showing synergistic effects—specifically a 12% reduction in tumor progression for dual therapy and 2% tumor regression for triple therapy—the Deputy Controller refused the application on June 30, 2023

The refusal was grounded in lack of inventive step under Section 2(1)(ja), and non-patentability under Sections 3(d) (derivatives of known substances) and 3(i) (method of treatment) of the Patents Act, 1970

Section 3(i) of the Patents Act, 1970, which excludes processes for the medicinal treatment of humans but does not bar product/composition claims

Regarding Section 3(d), it followed the principle from Topotarget UK Ltd. v. Controller General of Patents, holding that a combination of separate active drugs cannot be treated as "derivatives" of each other

Section 2(1)(ja) for inventive step, where the court looked for technical advancement over prior art

Bayer Pharma Aktiengesellschaft v. Controller of Patents to establish that working examples (dosage/schedules) in a specification demonstrate feasibility and do not convert a product claim into a method of treatment

The Court found the Controller’s objection under Section 3(i) misplaced, noting that Claim 1 is framed as a "pharmaceutical combination" (a product) and the administration terms are merely functional descriptors, not method steps

On Section 3(d), the Court observed that the Controller failed to identify any "known substance" from which the combination was derived and noted that a mix of independent active agents falls outside the scope of "derivatives" mentioned in the Section 3(d) Explanation

Regarding inventive step, the Court analyzed prior arts D1-D4 and determined that none disclosed the specific combination of Encorafenib and Cetuximab/Erlotinib

The Court held that the Controller failed to explain how a Person Skilled in the Art (PSITA) would be motivated to select and combine these specific compounds from the broad teachings of the prior art

The Court credited the Appellant’s clinical data as evidence of technical advancement and surprising results (tumor regression) which the Controller failed to properly rebut

The Court set aside the impugned order and remanded the application to the Controller for de novo reconsideration, with directions to dispose of the application within six months after providing a fresh hearing