Array Biopharma Inc v Deputy Controller of Patents and Designs (2026)

Summary

“The present appeal has been filed under Section 117A of the Patents Act, 1970 ... assailing the order dated 30.06.2023 ... under Section 15 of the Act refusing the Patent Application No. 450/DELNP/2015 titled ‘PHARMACEUTICAL COMBINATION COMPRISING A B RAF INHIBITOR AN EGFR INHIBITOR AND OPTIONALLY A PI3K ALPHA INHIBITOR’ ... on the ground of lack of inventive step under Section 2 (1) (ja) of the Act and non patentability under Sections 3(d) and 3(i) of the Act.” (para 1) The Court noted that “the present invention pertains to a combination of a B-Raf kinase inhibitor and an Epidermal Growth Factor Receptor (EGFR), which is also known as ErbB-1 or HER-1 inhibitor and, optionally a third inhibitor, a phosphatidylinositol 3-kinase (PI3-kinases or PI3K), and is used for the treatment of proliferative diseases” (para 6). “The dual combination claimed under claim 1 of the subject application comprises B-Raf inhibitor Compound A (Encorafenib) which is a B-Raf Inhibitor and Cetuximab/Erlotinib (EGFR inhibitor). Further, optionally, claim 1 also claims a triple recombination of the compounds.” (para 8) The Controller had found that “the triple combination is a method of treatment and falls within the ambit of combinational therapy” (para 45).

The Court found that “none of the cited prior art D1 to D4 specify the combination of compound A (B-Raf Inhibitor), Encorafenib, and Erlotinib/Cetuximab (EGFR inhibitor)” (para 29) and was “not satisfied with the reasoning given under the objection of lack of inventive step in the impugned order” (para 36). On section 3(d) it held that “the learned Controller has erroneously presumed the known compound from the compounds disclosed under the cited prior art, which was neither specified nor identified in the impugned order” (para 42); on section 3(i), that “claim 1 of the subject application is not framed as a process/ a protocol/ a dosing schedule, or a treatment regimen” (para 51). Of the objection under sections 10(5) and 10(4)(c), it said the Controller’s paragraph “sadly lacks in providing any reason whatsoever” (para 53). It ordered: “the subject matter patent application is remanded back to the learned Controller for denovo reconsideration of the objections raised. The learned Controller is directed to dispose of the subject patent application within a period of six months from date of receipt of this Order.” (para 54)

What the court decided

1. Motivation to choose the compounds. “In such a case, it becomes crucial to discuss such motivation/teaching to choose the specific compounds of the combination claimed under claim 1 of the present invention. The impugned order completely failed to discuss that how the Person Skilled in the Art would be motivated to choose the claimed compounds, i.e., Compound-A (Encorafenib) and Erlotinib / Cetuximab (from D2 or any other cited prior arts) to apply it to the combination mentioned under para 19 of D2.” (para 28)
2. Individual and generic disclosures. Of D2 the Court held that “although para 71 of D2 specifies the inhibitor erlotinib/ Cetuximab individually, however, not the combination thereof. It is observed in paragraph 19 of D2 that EGFR” (“Epidermal Growth Factor Receptor”) “inhibitors are mentioned in combination with B-raf inhibitor, but it is only EGFR inhibitors in general and not erlotinib/ Cetuximab specifically.” (para 19)
3. The prior art as a whole. “Therefore, the submission of the respondent as mentioned under para 4.4.3 above that D4 discloses all the 3 compounds as claimed in claim 1 of the present invention, cannot be accepted. Thus it can be safely inferred that none of the cited prior art D1 to D4 specify the combination of compound A (B-Raf Inhibitor), Encorafenib, and Erlotinib/Cetuximab (EGFR inhibitor). Further, the prior arts D1 to D4 also fail to disclose the combination of compound A (B-Raf Inhibitor), Encorafenib, and EGFR inhibitors Erlotinib or Cetuximab and optionally, Compound B, i.e. PI3K” (“phosphatidylinositol 3-kinase”) “-α inhibitor (alpelisib).” (para 29)
4. Efficacy data on other compounds. “The impugned order, based on the abovementioned data from D2 and D3, rejects the enhanced efficacy provided under examples 2 and 3 of the CS” (“Complete Specifications”) “of subject application however, fatally, does not discuss that the compounds used are BRAF and PI3K-α inhibitors which are not the same as disclosed in prior arts D1 to D4.” (para 35)
5. Reading documents together. “Similarly, the submission of the respondent that D1, D2/IPD2 and D4 read together would teach PSITA” (“person skilled in the art”) “to come to the claimed triple combination, is without any explanation as to what para/part of D1, D2 and D4 teaches to combine the 3 claimed compounds.” (para 35) “Therefore, based on the above discussion, this Court is not satisfied with the reasoning given under the objection of lack of inventive step in the impugned order.” (paras 35–36)
6. Combinations under section 3(d). The Court recorded that in Topotarget UK Limited v Controller General of Patents and Designs (IPDPTA/50/2023) “The Calcutta High Court emphasised that under Section 3(d) of the Act, a combination of two separate active drugs cannot be treated as derivatives of each other and therefore fall outside the scope of Section 3(d) entirely.” (para 41) and held: “Applying the aforesaid proposition it is clear that the learned Controller has erroneously presumed the known compound from the compounds disclosed under the cited prior art, which was neither specified nor identified in the impugned order.” (paras 41–42)
7. Identifying the known compound. “However, it is significant to note that even the reasons furnished for sustaining objections under section 2 (1) (ja) of the Act, also do not identify the known compound.” and “Therefore, it can be inferred that the ‘known compound’ in the cited prior art is not identified by the learned Controller.” (para 43) “Thus, this Court is unable to agree with the reasoning provided by the learned Controller under the objection of non-patentability under Section 3(d) of the Act.” (paras 43–44)
8. Simultaneous, separate or sequential administration. “While reading the expression ‘for simultaneous, separate or sequential administration’ under Claim 1 of the subject application in the light of its CS, it is clear that same is a functional descriptor of the claimed pharmaceutical combination and not a method step. It describes the range of ways in which the constituent actives, as a defined combination, may be administered without transforming the product into a method. This phrase does not impose or claim any particular therapeutic protocol, physician intervention, or sequential step.” (para 48)
9. Working examples and claim scope. “It is trite that working examples are provided by the patentee to demonstrate the workability and practical implementation of the claimed invention. For any invention to be patented, it is imperative for such invention to be demonstrated to be not only theoretical but also practical. Thus the mere providing of examples does not describe the scope of the patent.” The Court relied on Bayer Pharma Aktiengesellschaft v The Controller of Patents and Design (2024:DHC:2395), “wherein, it was emphasised that the working examples are essential for demonstrating the feasibility and workability of an invention, and do not define the patent’s scope.” (para 50)
10. Section 3(i): process or product. “It is clear that claim 1 of the subject application is not framed as a process/ a protocol/ a dosing schedule, or a treatment regimen.” The Court added that “the said provision bars a process, not a product and a combination”. (para 51)
11. An unreasoned claims objection. The Controller’s order read: “This objection is not met since the claims are not clear and sufficiently definitive to the scope of the invention in the absence of mention of any significant technological contribution over the prior art cited documents. Thus, these claims are not allowable u/s 10(5).” (para 52) The Court held: “The paragraph extracted hereinabove sadly lacks in providing any reason whatsoever. In view of the rejection by this Court of the reasons furnished by the learned Controller on the objections in respect of technical advancement as analysed in the preceding paragraphs, this Court is of the considered opinion that this objection too, needs reconsideration.” (paras 52–53)
12. Procedure. Remand. “In view of the aforesaid analysis, the subject matter patent application is remanded back to the learned Controller for denovo reconsideration of the objections raised. The learned Controller is directed to dispose of the subject patent application within a period of six months from date of receipt of this Order.” “Needless to state that the respondent shall grant an opportunity of hearing to the appellant before deciding the matter.” “The appeal is disposed of in the aforesaid terms.” (paras 54–55, 57)

What the court did not decide

“It is made clear that the learned Controller shall decide the subject patent application on its own merits without being influenced by the observations made above.” (para 56)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 16 September 2026.