Justice Tushar Rao Gedela, Delhi High Court
Pharmaceutical Combination Not A "Method" Merely Because It Mentions Administration: Delhi High Court Directs Reconsideration Of Array BioPharma’s Cancer Drug Patent Application
|The Court found the Controller’s refusal of Array BioPharma’s patent application for a B-Raf, EGFR and optional PI3K-alpha inhibitor cancer drug combination unsustainable on inventive step, Section 3(d), Section 3(i), and claim clarity reasoning, and directed fresh consideration within six months.
The Delhi High Court has held that a pharmaceutical combination claim does not become a method of treatment merely because it describes simultaneous, separate or sequential administration, while remanding Array BioPharma’s refused patent application concerning a cancer drug combination for fresh consideration.
The Court was hearing Array BioPharma Inc.’s appeal under Section 117A of the Patents Act, 1970, against the refusal of its patent application titled “Pharmaceutical Combination Comprising A B Raf Inhibitor, An EGFR Inhibitor And Optionally A PI3K Alpha Inhibitor”. The Controller had refused the application on the grounds of lack of inventive step under Section 2(1)(ja) and non-patentability under Sections 3(d) and 3(i) of the Act.
A Bench of Justice Tushar Rao Gedela, while examining the Section 3(i) objection, observed:
“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 the 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.”
Advocate Archana Shankar appeared for Array BioPharma, while Central Government Standing Counsel Rohan Jaitley appeared for the Controller.
Background
Array BioPharma’s application concerned a pharmaceutical combination comprising Encorafenib as a B-Raf inhibitor, Cetuximab or Erlotinib as an EGFR inhibitor, and optionally Alpelisib as a PI3K-alpha inhibitor. The appellant argued that the combination showed technical advancement and synergistic therapeutic effect through clinical data, including slowing of tumour progression and tumour regression in specific test groups.
The Controller refused the application after considering prior art documents and holding that the claimed combination lacked inventive step, fell within Section 3(d), and amounted to combination therapy or a method of treatment barred under Section 3(i).
Array BioPharma argued that the claims were product claims directed to a pharmaceutical combination, not a treatment protocol. It also contended that the Controller failed to identify the closest prior art, did not explain why a person skilled in the art would be motivated to select and combine the specific claimed compounds, and wrongly treated independent active pharmaceutical agents as falling within Section 3(d).
Court’s Observations
The Court examined the prior art documents relied upon by the Controller and found that none disclosed the specific combination claimed in the application. While some prior art referred generally to B-Raf inhibitors, EGFR inhibitors or PI3K inhibitors, the Court found that the precise claimed combination of Encorafenib with Erlotinib/Cetuximab, and optionally Alpelisib, was not disclosed.
The Court noted: “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-α inhibitor (alpelisib).”
The Court further held that the Controller failed to explain how a person skilled in the art would be motivated to arrive at the claimed combination from the cited documents.
The Court observed: “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.”
The Court also examined the technical advancement data relied upon by Array BioPharma. It noted that Examples 2 and 3 in the complete specification showed that the dual combination slowed tumour progression, while the triple combination resulted in tumour regression.
The Court recorded: “Examples 2 and 3 of the claimed invention provide the data from the clinical studies which, according to the appellant, indicate that the tumor growth from day 1 to day 29 was reduced in group 6 and there was regression in group 8. The dual combination of Compound A with Cetuximab when administered on Group 6, slowed down the tumour progression to 12% and significant inhibition. The table shows the improvement in combination upon Compound A monotherapy in Group 2 ( 95%) and Cetuximab monotherapy in Group 4 (88%). Similarly, the triple combination of Compound A, Compound B, and Cetuximab when administered on Group 8, resulted in tumor regression by -2%.”
Finding that the Controller compared the application with prior art involving different compounds, the Court held:
“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 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.”
The Court therefore concluded that it was not satisfied with the reasoning on lack of inventive step.
On Section 3(d), the Court found that the Controller had not identified the “known compound” from the cited prior art. The Court accepted the principle from Topotarget UK Limited (2023) that a combination of separate active drugs cannot automatically be treated as derivatives of each other for Section 3(d).
The Court 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.”
It further stated: “Learned controller, so far as efficacy and combinations are concerned, has relied on the reasoning given under the objection of lack of inventive step. 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.”
Accordingly, the Court disagreed with the Controller’s reasoning under Section 3(d).
Rejecting the Section 3(i) reasoning, the Court held that working examples or dosing schedules in the specification do not define the scope of the patent claim. Relying on Bayer Pharma Aktiengesellschaft (2024), the Court reiterated that working examples demonstrate feasibility and workability but do not convert a product claim into a treatment method.
The Court observed: “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 also found that the Controller’s claim clarity objection under Sections 10(5) and 10(4)(c) lacked reasoning and required reconsideration.
Conclusion
The Court remanded the patent application to the Controller for fresh consideration of the objections and directed disposal within six months, after granting Array BioPharma an opportunity of hearing. It clarified that the Controller must decide the application on its own merits without being influenced by the Court’s observations.
The Court directed: “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.”
Cause Title: Array BioPharma Inc v. Deputy Controller of Patents and Designs (Neutral Citation: 2026:DHC:5856)
Appearances
Appellant: Advocates Archana Shankar and Devender Rawat
Respondent: Central Government Standing Counsel Rohan Jaitley, with Advocates Varun Pratap Singh, Akshay Sharma, Dev Pratap Shahi and Yogya Bhatia