The Five-Step Indian Formulation

1The five-step test, commonly referred to as the Roche steps, to determine lack of inventive step was formulated by the Division Bench of Delhi High Court after analysing the case laws on the point in Cipla v F Hoffmann-La Roche (2015). The five steps can be summarised as follows:

(1) Step No.1: To identify an ordinary person skilled in the art;
(2) Step No.2: To identify the inventive concept embodied in the patent;
(3) Step No.3: To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date;
(4) Step No.4: To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary application of law or involve various different steps requiring multiple, theoretical and practical applications; and
(5) Step No.5: To decide whether those differences, viewed in the knowledge of alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hindsight approach. (Cipla v F Hoffmann-La Roche (2015), para 151.)

2Later decisions have differed on the extent to which the five-step test needs to be followed. In Calico, the Delhi High Court held that the Controller is required to follow the test and “cannot absolve itself of this duty by merely citing paragraphs from the judgement.” The Court refused the sustain the finding on the lack of inventive step in the absence of such an effort by the Controller. (Calico Life Sciences v Joint Controller of Patents and Designs (2026), para 18). But the Division Bench of the Delhi High Court held that the adjudication of the lack of inventive step should in in accordance with the Patents Act and the five-steps in Roche “merely provide guidance” and cannot be regarded as “commandments cast in stone”. The Court observed that not following the five-steps is not a reason for vitiating the decision solely on that ground. (Sulzer Mixpac v Assistant Controller of Patents and Designs (2026), para 24.)

3Some versions of this determination confine the enquiry to three elements. In Agriboard, the Court noted the three elements the Controller must consider while rejecting an invention for lack of inventive step: (1) the invention disclosed in the prior art; (2) the invention disclosed in the application under consideration; and (3) the manner in which subject invention would be obvious to a person skilled in the art. (Agriboard International v Deputy Controller of Patents and Designs (2022), paras 24–26.) The Court observed that “the Controller has to analyse as to what is the existing knowledge and how the person skilled in the art would move from the existing knowledge to the subject invention, captured in the application under consideration. Without such an analysis, the rejection of the patent application under Section 2(1)(ja) of the Act would be contrary to the provision itself.” (Agriboard, para 26.) The same three elements are restated in Calico, para 18.

4With regard to the third step, and the source of the common general knowledge imputed under it, the Bombay High Court observed that “it is wholly impermissible for the Respondent, in a quasi-judicial order under Section 15 of the Patents Act, to invoke ‘common general knowledge’ as a self-sufficient ground for rejecting a patent application without setting out and substantiating the sources of such common general knowledge on the day of patent application.” The Court added that the Controller is “required to identify the source of the asserted common general knowledge and to demonstrate that such source was published prior to the priority date of the application” (Deepak Nitrite v Assistant Controller General of Patents and Designs (2026), para 10). The Court rebuked a bald assertion of ‘common general knowledge’ without setting out the identifiable sources and basis and opined that such an assertion will “not only impermissible but is also wholly arbitrary and contrary to the principles of natural justice.” (Deepak Nitrite, para 11.)

5As for the fourth and fifth steps, where several documents are read together, the Delhi High Court observed that “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 Court pointed out that the “impugned order completely failed to discuss that how the Person Skilled in the Art would be motivated to choose the claimed compounds” (Array Biopharma v Deputy Controller of Patents and Designs (2026), para 28). The Court further observed “that D1, D2/IPD2 and D4 read together would teach PSITA 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.” (Array Biopharma, para 35.)

6In Sulzer Mixpac v Assistant Controller of Patents and Designs (2026) (para 32), the Delhi High Court observed that where the prior art is the applicant’s own “the aspect of inventiveness has to be seen from the point of view of a person skilled in the art and, especially in a case where the inventor is the same, the leap from prior art to the subject invention is much more easily scaled.”