High Court of Delhi Mandates Reasoned Orders and Five-Step Inventive Step Analysis for Patent Rejections

The Appellant filed Indian Patent Application No. 3029/DELNP/2015 for a "stable preservative-free mydriatic and anti-inflammatory solution for injection".

The invention comprises a combination of Phenylephrine (a weak base) and Ketorolac (a weak acid) in a sodium citrate buffer, specifically formulated to be free of antioxidants and preservatives to avoid ocular toxicity.

Despite filing experimental data showing stability for over 30 months, the Respondent (Deputy Controller) refused the application on January 31, 2020.

The refusal was based on lack of inventive step under Section 2(1)(ja) and non-patentability under Section 3(e) of the Patents Act, 1970, citing prior arts D1–D3.

The Appellant challenged the order as being unreasoned and failing to address their technical submissions.

1. Whether the impugned order refusing the patent application was a speaking and reasoned order that addressed the Appellant's technical evidence.

2. Whether the Respondent correctly applied the legal test for determining "inventive step" under Section 2(1)(ja) in light of judicial precedents.

3. Whether the composition qualified as a mere admixture under Section 3(e) or exhibited a synergistic effect.

The court primarily applied the Patents Act, 1970, specifically Section 2(1)(ja) regarding the definition of "inventive step" and Section 3(e) regarding non-patentable admixtures.

The court relied on the five-step test for determining obviousness established by the Delhi High Court Division Bench in F.Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. (2015), which requires identifying the person skilled in the art, the inventive concept, and the differences between prior art and the invention to rule out a hindsight approach.

The Court found that the Respondent’s order was "unreasoned" and "non-speaking".

Specifically, the Respondent failed to apply the mandatory five-step test from F.Hoffmann-La Roche.

The court noted that the Respondent ignored crucial technical arguments: (a) that combining a weak acid (Ketorolac) and a weak base (Phenylephrine) usually results in instability/precipitation, making a stable, antioxidant-free version non-obvious; and (b) that the Appellant provided data showing 30 months of stability, which the Respondent dismissed as "not surprising" without explaining how such stability is inherently achieved in the absence of preservatives.

Regarding Section 3(e), the court observed that the Respondent summarily rejected the claim in a single line without analyzing the synergistic effects claimed by the Appellant.

The Court concluded that the Respondent reduced the procedure to a "mere formality" by failing to engage with the response to the FER and post-hearing submissions.

The Court set aside the order dated 31.01.2020 and remanded the matter back to the Respondent for fresh consideration.

The Respondent is directed to issue a "speaking and reasoned order" within four months after granting a fresh hearing and considering all technical data and prior art differences.