Summary: In Array BioPharma Inc. v Deputy Controller of Patents, the Delhi High Court set aside the Controller’s refusal of Array BioPharma’s combination patent application and remanded it for fresh consideration. The Court held that the Controller had wrongly applied Section 3(d) to a combination of independent active agents, and incorrectly treated a product claim as a method-of-treatment claim. The ruling reinforces that combination patent claims must be assessed on proper inventive-step reasoning tied to the closest prior art and that Section 3(d) does not bar combinations of distinct, independently active pharmaceutical (or agrochemical) agents, giving innovators a stronger footing in defending multi-component combination inventions in India.
OVERVIEW
The Delhi High Court has set aside a refusal order of the Controller of Patents and Designs and remanded a pharmaceutical combination patent application (Application No. 450/DELNP/2015 filed by Array BioPharma Inc.) for fresh consideration. The judgement, dated July 23, 2026, carries significant implications for the pharmaceutical and agrochemical industry, particularly for innovators seeking patent protection for combination patents in India.
THE CLAIMED INVENTION
The application titled PHARMACEUTICAL COMBINATION COMPRISING A B-RAF INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K ALPHA INHIBITOR claims:
- Dual combination: Compound A (Encorafenib, a specific B-Raf inhibitor) in combination with an EGFR inhibitor, being either Cetuximab or Erlotinib.
- Triple combination (optional): The dual combination supplemented with Compound B (Alpelisib, a specific PI3K-alpha inhibitor).
The three compounds operate through distinct mechanisms of action and are claimed together for simultaneous, separate, or sequential administration.
SCOPE OF THE EXAMPLES PRESENTED
The Complete Specification contained pre-clinical and clinical study data in Examples 1, 2, and 3, which the appellant relied upon to demonstrate synergistic therapeutic effect:
- Example 1: Described the treatment schedule using Compound A (oral capsule, once or twice daily), Compound B (oral tablet, once or twice daily), and Cetuximab (intravenous infusion, 400 mg/m² initial / 250 mg/m² subsequent). The Controller mischaracterised it as evidence that the invention was a treatment method.
- Examples 2 and 3: Contained data from Phase Ib and Phase II clinical trial studies comparing the anti-tumour effect of monotherapies and combinations. The key findings from this data were as follows:
- Compound A monotherapy: tumour progression of 95% (minimal inhibition).
- Compound B monotherapy: tumour progression of 57%.
- Cetuximab monotherapy: tumour progression of 88% (minimal inhibition).
- Dual combination ̶ Compound A + Cetuximab: tumour progression slowed dramatically to 12%.
- Triple combination ̶ Compound A + Compound B + Cetuximab: tumour regression of −2%, meaning the combination not only halted but reversed tumour growth.
GROUNDS OF REJECTION BY THE CONTROLLER
The Deputy Controller refused the application on the following grounds:
Lack of Inventive Step – Section 2(1)(ja)
The Controller cited four prior art documents (D1–D4) to determine that the claimed combination lacked inventive step. It was concluded that an individual skilled in the art, when considering these prior arts collectively, would have been motivated to develop the triple combination comprising Compound A, Compound B, and EGFR inhibitors. Additionally, the Controller found that the clinical data presented in Examples 2 and 3 did not demonstrate enhanced efficacy over the prior art, referencing data from D2 and D3 to conclude that similar combinations and outcomes were previously known.
Non-Patentability – Section 3(d)
The Controller held that since the combinations were disclosed in the prior art, the claimed invention amounted to a known combination and therefore fell within the bar under Section 3(d) of the Act.
Non-Patentability – Section 3(i)
The Controller held that the claim, particularly the phrase “for simultaneous, separate or sequential administration” was a method of treatment or combination therapy, and not a product claim.
THE COURT’S ANALYSIS AND REASONS FOR OVERTURNING THE REJECTION
On Inventive Step (Section 2(1)(ja))
The Court found that none of the prior arts individually or collectively, disclosed the specific combination:
- D1 disclosed Compound A (Encorafenib) generically, and while it mentioned PI3K inhibitors as additional agents, it did not disclose a PI3K-alpha inhibitor specifically, nor any EGFR inhibitor as a combination partner.
- D2/IPD2 referred to EGFR inhibitors, including Erlotinib and Cetuximab and their use in combination with B-Raf inhibitors, but did not disclose Encorafenib, nor did it disclose Erlotinib and Cetuximab as a specific combination partner for Encorafenib.
- D3 involved combining Dabrafenib (a different B-Raf inhibitor) and Omipalisib (a different PI3K inhibitor).
- D4 disclosed PI3K-alpha inhibitors and noted synergy between EGFR and PI3K/Akt pathway inhibitors but did not specify the claimed EGFR inhibitor or the claimed PI3K-alpha inhibitor (Alpelisib).
Critically, the Court held that the impugned order contained no analysis of how or why a person skilled in the art would be motivated to select the specific claimed compounds from the prior art landscape. The Controller failed to identify the closest prior art, failed to articulate the technical problem solved by the claimed invention over that prior art, and failed to explain the route by which any person skilled in the art would arrive at the precise triple combination from the cited documents. The Court was not satisfied with the reasoning on lack of inventive step.
On Non-Patentability under Section 3(d)
The Court rejected the Section 3(d) bar on two separate grounds:
- Threshold inapplicability: Following the IPAB decision in Ajantha Pharma Ltd. v. Allergan Inc. and the Calcutta High Court judgement in Topotarget UK Ltd. v. Controller General of Patents (IPDPTA/50/2023), the Court affirmed that Section 3(d) does not apply to a combination of two or more independent active pharmaceutical agents (each with its own distinct chemical identity, mechanism of action, and therapeutic profile). The “combination” contemplated by the Explanation to Section 3(d) refers only to a combination of derivatives or derivatives with the parent substance and not a combination of two separate independent drugs.
- Failure to identify the known compound: The impugned order failed to identify which specific known compound it regarded the claimed combination as being a derivative of. The Court found this to be a fundamental defect in the reasoning.
On Non-Patentability under Section 3(i)
The Court firmly held that Claim 1 of the application is a product claim, not a method of treatment claim. The phrase “for simultaneous, separate or sequential administration” is a functional descriptor of the combination as a product and it describes the modes in which the combination’s constituent actives may be administered.
The Court relied on prior Delhi High Court decisions in Nestle SA v. Controller of Patents & Designs (CA (COMM).IPD-PAT) 22/2022), etc., which contended that working examples in a complete specification are intended to demonstrate the feasibility and workability of an invention. They do not define the scope of the patent. The claims define the scope, not the examples.
OUTCOME AND KEY TAKEAWAYS
The High Court set aside the impugned order and remanded the matter back to the Controller of Patents and Designs for de novo reconsideration of all objections. The Order reinforces several important principles of Indian patent law in the context of multi-component combination inventions:
- A product claim pertaining to a pharmaceutical combination is not considered a method of treatment solely because the specification references clinical dosing schedules or administration routes.
- Section 3(d) does not apply to combinations of independent active pharmaceutical (or, by analogy, agrochemical) agents. The patent office must identify the specific “known substance” from which the claimed combination is alleged to be a derivative.
- A refusal on grounds of inventive step requires specific identification of the closest prior art, the technical problem, and the motivation for a person skilled in the art to arrive at the specific claimed combination.
