Array BioPharma Inc. v. Deputy Controller of Patents and Designs

High Court of Delhi at New Delhi, Single Judge | Date of Decision: 23.07.2026 (Reserved on: 18.05.2026) Case Number: C.A.(COMM.IPD-PAT) 37/2023 Bench: Hon’ble Mr. Justice Tushar Rao Gedela

BACKGROUND

The Appellant, Array BioPharma Inc., filed Indian Patent Application No. 450/DELNP/2015 titled “PHARMACEUTICAL COMBINATION COMPRISING A B RAF INHIBITOR AN EGFR INHIBITOR AND OPTIONALLY A PI3K ALPHA INHIBITOR” (“subject application”), tracing priority to a US provisional application filed 07.08.2012 (US 61/680,473), followed by PCT Application PCT/US2013/053619 filed 05.08.2013 (published as WO2014/025688 on 13.02.2014). The corresponding Indian application was filed on 19.01.2015 and published under Section 11A of the Patents Act, 1970 on 26.06.2015; a request for examination was filed on 01.08.2016. The claimed invention (Claim 1) relates to a pharmaceutical combination comprising a B-Raf inhibitor of a specified formula (Compound A, INN Encorafenib) or a pharmaceutically acceptable salt thereof, an EGFR inhibitor (Cetuximab or Erlotinib), and, optionally, a PI3K-α inhibitor (Compound B, INN Alpelisib, a compound of a specified formula), for simultaneous, separate or sequential administration the dual combination comprising Compound A with the EGFR inhibitor and the optional triple combination adding Compound B. The invention’s field is the treatment of proliferative diseases, with the Complete Specification (“CS”) asserting synergistic, surprising and unexpected therapeutic benefits over monotherapy, including fewer side effects, more durable response, improved quality of life and decreased morbidity, supported by clinical trial data (Phase Ib and Phase II) set out in Examples 2 and 3, comparing tumour progression across treatment groups (e.g., Group 6: Compound A + Cetuximab dual combination showing 12% tumour progression, against Compound A monotherapy’s 95% and Cetuximab monotherapy’s 88%; Group 8: Compound A + Compound B + Cetuximab triple combination showing tumour regression of (-)2%, against the respective monotherapy figures).

Procedurally, the Indian Patent Office issued a First Examination Report (“FER”) on 24.08.2018, to which the Appellant responded on 06.02.2019. A hearing under Section 15 was, after several adjournments (rescheduled from 19.10.2020 to 19.11.2020, then to 21.12.2020, then to 05.01.2021), ultimately conducted on 05.01.2021, followed by written submissions on 20.01.2021. After a considerable lapse of time, a further hearing notice dated 10.03.2023 fixed the matter for 17.03.2023, which after an adjournment and rescheduling to 21.03.2023 citing an incorrect prior art citation was followed by a Rule 138 extension petition (30.03.2023) and hearing submissions filed on 01.05.2023. By order dated 30.06.2023 (“impugned order”), the Deputy Controller of Patents and Designs refused the subject application under Section 15 of the Patents Act, on grounds of lack of inventive step under Section 2(1)(ja) and non-patentability under Sections 3(d) (mere discovery of a new form/known substance without enhanced efficacy) and 3(i) (methods of medical treatment). The present appeal was filed under Section 117A of the Patents Act, 1970, challenging this refusal on all three grounds. The Controller relied on four prior art documents: D1 (WO2011025927), D2/IPD2 (1403/DELNP/2012, titled “DETERMINING SENSITIVITY OF CELLS TO B-RAF INHIBITOR TREATMENT BY DETECTING KRAS MUTATION AND RTK EXPRESSION LEVELS”), D3 (WO2011/046894 A1) and D4 (WO2011/029082).

ISSUES FOR DETERMINATION

Whether the claimed invention the dual combination of Compound A (Encorafenib, a B-Raf inhibitor) with an EGFR inhibitor (Cetuximab/Erlotinib) and the optional triple combination additionally including Compound B (Alpelisib, a PI3K-α inhibitor) was disclosed, individually or in combination, by prior art documents D1 to D4, such that the claimed invention lacked inventive step under Section 2(1)(ja) of the Patents Act, 1970.
Whether the technical/clinical trial data relied upon by the Appellant (Examples 2 and 3 of the CS) demonstrated a synergistic, unexpected therapeutic effect sufficient to establish inventive step and whether the Controller had properly analysed this data against comparable data in the cited prior art (particularly D2 and D3).
Whether the claimed pharmaceutical combination was non-patentable under Section 3(d) of the Patents Act, 1970, as a mere discovery of a new form or combination of known substances without enhancement of known efficacy.
Whether the claimed invention, properly construed, was a product claim (a “pharmaceutical combination”) or, as held by the Controller, a method/process of medical treatment excluded from patentability under Section 3(i) of the Patents Act, 1970.
Whether the claims satisfied the requirements of clarity and sufficiency of description under Sections 10(4)(c) and 10(5) of the Patents Act, 1970.
Whether, in light of the above, the impugned order was legally sustainable or whether the matter warranted remand to the Controller for fresh consideration.

KEY HOLDINGS OF THE COURT

On inventive step (Section 2(1)(ja)), the Court undertook a detailed, document-by-document comparison of D1 to D4 against the specific claimed compounds and combinations and held that none of the four prior art documents, whether read individually or in combination, disclosed the specific combination claimed namely, Compound A (Encorafenib) as the B-Raf inhibitor together with Erlotinib/Cetuximab as the EGFR inhibitor and, optionally, Compound B (Alpelisib) as the PI3K-α inhibitor. Specifically, the Court held: (a) D1 discloses a B-Raf inhibitor of the claimed formula and mentions PI3K as one of several possible “additional therapeutic agents” (among many others such as MEK, mTOR, HSP90, AKT, CDK9, PAK, Protein Kinase C), but does not disclose the specific PI3K-α inhibitor claimed; (b) D2/IPD2 discloses Erlotinib/Cetuximab and various B-Raf inhibitors generically and discloses combining a B-Raf inhibitor with an EGFR inhibitor as a treatment approach for B-Raf-inhibitor-nonresponsive tumours, but does not disclose Encorafenib specifically, nor does it specifically combine Erlotinib/Cetuximab with a B-Raf inhibitor (as opposed to EGFR inhibitors generally) and, critically, the impugned order failed to explain why a person skilled in the art (“PSITA”) would be motivated to select the specific claimed compounds from D2’s generic disclosures; (c) D3 discloses a combination of a B-Raf inhibitor and a PI3K inhibitor, but the specific compounds disclosed (a B-Raf inhibitor other than Encorafenib and a PI3K inhibitor – Omipalisib – rather than the claimed PI3K-α inhibitor Alpelisib) differ from those claimed and D3 contains no disclosure whatsoever of an EGFR inhibitor; (d) D4 discloses PI3K-α inhibitors generally and a general synergy between EGFR and PI3K/Akt pathway inhibition (citing external literature), but does not specify either the claimed EGFR inhibitor or the claimed PI3K-α inhibitor. The Court held that the impugned order’s reliance on D1, D2/IPD2 and D4 “read together” to establish motivation for the claimed triple combination was unsubstantiated, since the order did not identify which specific paragraph or portion of these documents would teach a PSITA to combine the three specific claimed compounds.
On the technical advancement/data comparison, the Court held that although the impugned order relied on data in Tables 2, 3 and 4 of D3 (and Figures 34A/34B of D2) to reject the Appellant’s claimed enhanced efficacy, this comparison was flawed because the compounds used in the prior art data were not the same compounds claimed in the subject application e.g., the B-Raf inhibitor in D3’s data tables was a different compound (not Encorafenib) and the PI3K inhibitor was Omipalisib (not Alpelisib); similarly, the RAF inhibitor used in the D2 data (Figures 34A/34B) was “RAF inh a,” a different compound from Encorafenib. The Court held that comparing efficacy data for different compounds could not properly support a conclusion that the claimed invention’s specific combination lacked demonstrated technical advancement and held itself “not satisfied with the reasoning given under the objection of lack of inventive step in the impugned order.”
On Section 3(d), the Court held that the impugned order’s reasoning was deficient because it did not identify or specify what “known compound” the claimed combination was said to be a mere derivative/form of the order simply cross-referenced its (already-rejected) inventive-step reasoning without independent analysis. The Court further held, relying on the Calcutta High Court’s decision in Topotarget UK Limited v. Controller General of Patents and Designs, Mumbai & Ors. (which held that a combination of two separate active drugs cannot be treated as derivatives of each other and therefore falls outside the scope of Section 3(d)), that the Controller’s approach apparently treating individual known compounds within the combination as attracting Section 3(d) was legally unsound, since Section 3(d) applies to a new form of a single known substance, not to a combination of distinct, independent active pharmaceutical agents. The Court accordingly held itself “unable to agree with the reasoning provided by the learned Controller under the objection of non-patentability under Section 3(d).”
On Section 3(i), the Court held that Claim 1, properly construed as a whole together with the CS, was directed to a “pharmaceutical combination” a product claim and not to a process or method of medical treatment. The Court held that the phrase “for simultaneous, separate or sequential administration” is a functional descriptor of how the constituent actives, as a defined combination, may be administered and does not transform the claim into a method step, since it imposes no particular therapeutic protocol, physician intervention or sequential procedural steps. The Court held that the Controller’s reliance on dosing/treatment-schedule details in Example 1 of the CS (describing dosage forms and administration routes for Compound A, Compound B and Cetuximab) was misplaced, since, applying this Court’s own prior ruling in Bayer Pharma Aktiengesellschaft v. The Controller of Patents and Design, working examples in a specification serve to demonstrate feasibility and practical workability of an invention but do not define or narrow the scope of the claims, which is determined by the claim language itself. Since Claim 1 as framed was not a process/protocol/dosing-schedule/treatment-regimen claim, the Court held that Section 3(i) did not apply, as that provision excludes processes, not products or combinations.
On Sections 10(4)(c)/10(5), the Court held that the impugned order’s reasoning on this objection was itself deficient (“lacks in providing any reason whatsoever”), and, in light of the Court’s rejection of the Controller’s reasoning on technical advancement/inventive step (upon which the clarity/sufficiency objection was expressly premised), held that this objection too required reconsideration.
Final holding and operative order: Having found the Controller’s reasoning on inventive step, Section 3(d) and Section 3(i) all deficient, the Court remanded the subject patent application to the Controller for de novo reconsideration of the objections raised, directing disposal within six months from receipt of the order, with a fresh opportunity of hearing to be granted to the Appellant and clarifying that the Controller was to decide the application on its own merits without being influenced by the Court’s observations. The appeal was disposed of in these terms.

STATUTORY PROVISIONS INVOLVED

Section 2(1)(ja) of the Patents Act, 1970, defining “inventive step,” was the central provision applied in the Court’s document-by-document analysis of D1 to D4; the Court held that none of the cited prior art, individually or in combination, disclosed or rendered obvious the specific claimed combination and that the Controller had failed to identify the specific teaching in any document that would motivate a PSITA to arrive at the claimed combination.

Section 3(d) of the Patents Act, 1970 (reproduced in the judgment), excluding from patentability the mere discovery of a new form of a known substance not resulting in enhanced known efficacy or mere discovery of new property/use of a known substance, was held inapplicable on the Court’s reasoning (following Topotarget) that a combination of distinct, independent active pharmaceutical agents cannot be treated as a “derivative” of a known substance for purposes of this provision and that the Controller’s order in any event failed to identify the specific “known compound” said to be relevant.

Section 3(i) of the Patents Act, 1970 (reproduced in the judgment), excluding from patentability any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings, was held inapplicable, the Court construing Claim 1 as a product claim (a pharmaceutical combination) rather than a method-of-treatment/process claim, applying and extending this Court’s reasoning in Bayer Pharma Aktiengesellschaft v. The Controller of Patents and Design regarding the distinction between claim scope and illustrative working examples.

Sections 10(4)(c) and 10(5) of the Patents Act, 1970, concerning sufficiency and clarity/definiteness of claims respectively, were the subject of a further objection which the Court held required reconsideration in light of its rejection of the Controller’s inventive-step reasoning, upon which the clarity/sufficiency objection had been expressly premised.

Section 11A of the Patents Act, 1970, governing publication of patent applications and Section 15 of the Patents Act, 1970, empowering the Controller to refuse an application, were referenced in the procedural history and as the basis of the impugned order respectively.

Section 117A of the Patents Act, 1970, under which the present appeal was filed before the High Court, was the jurisdictional basis for the appeal.

REASONING OF THE COURT

The Court’s reasoning was distinctively granular and document-specific, proceeding by extracting and reproducing the operative paragraphs of each of the four prior art documents verbatim and then testing each disclosure against the precise chemical identity of the compounds claimed in the subject application (Encorafenib, Cetuximab/Erlotinib and Alpelisib). This method allowed the Court to identify, with particularity, the gap between what each prior art document actually disclosed (often generic classes of inhibitors or specific but different compounds within the same therapeutic class) and what the claimed invention specifically required a gap the Court treated as fatal to any finding of anticipation or obviousness, since patent law requires that obviousness be established through the eyes of a PSITA presented with the actual, specific teachings of the prior art, not through hindsight-driven mosaicing of generic disclosures across multiple documents without an identified textual basis for the motivation to combine.

The Court’s reasoning was particularly critical of the Controller’s cross-referencing technique where the Section 3(d) objection simply incorporated by reference the reasoning given for lack of inventive step and the Section 10(5) objection likewise incorporated the technical-advancement reasoning reasoning that since the underlying inventive-step analysis was itself unsubstantiated (for failing to identify a “known compound” or specific motivating teaching), the objections built upon it necessarily failed as well, being derivative of an already-flawed foundation.

On Section 3(i), the Court’s reasoning drew a structural distinction, consistent with its own precedent in Bayer Pharma, between the claims (which define the legal boundaries of patent protection) and the specification’s working examples (which merely demonstrate practical feasibility). The Court reasoned that a dosing schedule appearing in a working example does not retroactively convert a product claim into a process claim, since the relevant question is what the claim itself recites and Claim 1, reciting a “pharmaceutical combination” comprising specified compounds “for simultaneous, separate or sequential administration,” described a product defined by its constituent components and their administrability, not a therapeutic protocol imposing specific steps, dosages or physician actions as the claimed subject matter.

Throughout, the Court’s approach reflected a broader methodological concern evident in its extensive, almost example-by-example reconstruction of the prior art comparisons that the Controller ought to have but did not perform that inventive-step and non-patentability findings in complex pharmaceutical combination cases require rigorous, specific, compound-level comparison rather than generalized statements that “such combinations are known” from cited prior art without identifying precisely which compounds and which disclosures support that characterization.

DOCTRINAL SIGNIFICANCE

Within the bounds of what was actually decided, this is a detailed, technically granular remand decision that does not itself grant the patent but instead vacates the Controller’s specific findings and directs fresh, more rigorous examination. Its principal significance lies in illustrating a methodologically rigorous approach to inventive-step analysis for pharmaceutical combination patents requiring the Controller (and, by extension, patent examiners generally) to identify with precision which specific compounds are disclosed in each prior art reference, to avoid conflating structurally or functionally similar but chemically distinct compounds (e.g., different B-Raf or PI3K inhibitors within the same therapeutic class) and to articulate, with reference to specific textual teachings, why a PSITA would be motivated to combine disclosures across multiple documents to arrive at the claimed invention. On Section 3(d), the judgment reinforces and applies the Calcutta High Court’s holding in Topotarget that a combination of independent, structurally unrelated active pharmaceutical agents cannot be treated as a “derivative” of a known substance for purposes of that provision, further consolidating this interpretive position within Delhi High Court patent jurisprudence. On Section 3(i), the judgment reinforces the distinction (previously articulated in Bayer Pharma and referenced authorities such as Nestle SA and Medilabo RFP Ink) between product claims to a pharmaceutical combination and process claims to a method of treatment, holding that administrative/dosing details in illustrative examples do not convert the former into the latter. The decision is, however, expressly confined to remand: the Court did not itself determine that the patent ought to be granted and directed the Controller to decide the matter afresh on its own merits, “without being influenced” by the Court’s observations meaning the ultimate patentability determination remains to be made at the administrative level, subject to the corrected legal framework and evidentiary rigor the Court has now mandated.

Array BioPharma Inc. v. Deputy Controller of Patents and Designs

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