TMThe Delhi High Court has delivered an important ruling for pharmaceutical patent applicants by setting aside key reasoning adopted by the Patent Office in refusing a patent application for a cancer-treatment combination. In Array BioPharma Inc. v. Deputy Controller of Patents and Designs (C.A. (COMM.IPD-PAT) 37/2023), the Hon’ble Court emphasised that patentability objections must rest on clear claim analysis and properly reasoned comparison with prior art, not on assumptions drawn from clinical examples or unexplained combinations of earlier disclosures.
The dispute before the court
Array BioPharma's application concerned a pharmaceutical combination comprising a B-Raf inhibitor, an EGFR inhibitor and, optionally, a PI₃K-inhibitor for treating proliferative diseases. The Patent Office refused the application under Section 15 of the Patents Act, 1970, citing lack of inventive step under Section 2(1)(ja) and non-patentability under Sections 3(d) and 3(i).
The central questions before the Court were whether the claimed combination was obvious in light of the cited prior art, whether it attracted the enhanced-efficacy restriction under Section 3(d), and whether its reference to simultaneous, separate or sequential administration transformed the claim into a prohibited method of treatment under Section 3(i).
A pharmaceutical combination is not necessarily a treatment method.
The Court's treatment of Section 3(i) is particularly significant.
The Controller had relied substantially on clinical examples and dosing information contained in the specification to conclude that the invention related to therapy and treatment. The Court disagreed. It held that the scope of patent protection is determined principally by the claims. 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.
Claim 1 was articulated as a pharmaceutical combination, rather than a treatment regimen, dosage plan, or therapeutic methodology. The phrase allowing for concurrent, individual, or successive administration was regarded as a functional characterization of the combination instead of an asserted medical method. Section 3(i), the Court reasoned, excludes processes of treatment, not product or combination claims merely because they may ultimately be used in therapy.
Inventive step requires a reasoned prior-art analysis
On inventive step, the Court found the Controller's reasoning unsatisfactory. The impugned order relied upon combinations of disclosures from several prior-art documents, but the Court noted important differences between the compounds and combinations actually disclosed in those documents and the compounds claimed in the application.
Most importantly, the Court saw no sufficient explanation as to which specific passages in the cited documents would lead a person skilled in the art to combine the three claimed compounds. The reasoning could not simply assume that references to related drug classes or combinations established obviousness of the precise claimed combination to a person skilled in the art(PSITA).
The decision therefore reinforces a fundamental examination principle: where an inventive-step objection depends on mosaicing multiple documents, the reasoning must explain the technical basis and motivation for the proposed combination.
Section 3(d): the importance of identifying the “Known Substance”
The Court also rejected the reasoning supporting the Section 3(d) objection. The Controller had treated the pharmaceutical combination as falling within the provision without clearly identifying the relevant known substance or derivative.
The Court relied on the reasoning of the Calcutta High Court in Topotarget UK Limited v. Controller General of Patents and Designs, Mumbai & Ors. (IPDPTA/50/2023), which distinguished 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.
Why the Judgment matters
The judgment has practical importance for both pharmaceutical innovators and patent professionals. It underlines the need for precise claim construction and disciplined examination reasoning. For applicants, it emphasizes the necessity of drafting claims that clearly distinguishes a pharmaceutical product or combination from an proscribed method of treatment.
For the Patent Office, the decision is a reminder that objections under Sections 2(1)(ja), 3(d), 3(i), 10(4)(c) and 10(5) must be independently reasoned. A conclusion under one provision cannot substitute for the statutory analysis required under another.
The Court remanded the application for de novo consideration within six months, with an opportunity of hearing and a direction that the Controller decide the matter independently on its merits.
Conclusion
The Array BioPharma judgment is an important reminder that pharmaceutical patent applications must be examined on the basis of the invention actually claimed and the specific requirements of the Patents Act. A pharmaceutical combination cannot be rejected merely because its specification includes clinical examples or because individual components or related drug combinations are known in the prior art.
The decision does not determine that the claimed invention is ultimately patentable. Instead, it requires the Patent Office to apply each statutory provision independently and support its conclusions with clear and reasoned analysis. For future pharmaceutical combination patents, the judgment is likely to reinforce a more disciplined approach to claim construction, inventive-step analysis and the application of Sections 3(d) and 3(i).
In that sense, the decision is significant not only for pharmaceutical innovators but also for the continuing development of a consistent and reasoned patent examination practice in India.
Disclaimer: This article is intended for general educational and informational purposes only and does not constitute legal advice. The law and applicable procedures may change, and readers should seek professional advice based on their specific circumstances.