Post-Filing Data Cannot Establish Technical Advancement if Original Patent Specifications Lack Implicit Disclosure of the Alleged Properties

The Appellant filed a patent application (No. 201911048481) for a "Herbal Powder Composition for the Treatment of Asthma" comprising six Indian herbs

The Assistant Controller (Respondent) refused the application on 16.09.2020 on grounds that it failed to meet the requirements of Section 2(1)(j) (novelty), Section 3(p) (traditional knowledge), and Section 10(4)(a) & (b) (sufficiency of disclosure) of the Patents Act, 1970

The Appellant argued that the selection and optimization of the specific ratios of the six herbs involved an inventive step and produced a synergistic effect

During the hearing stage, the Appellant submitted an affidavit introducing new data, including a classification of asthma into five types and assertions of side effects if the ratios were altered

The Appellant also contended that an agreement with the National Biodiversity Authority (NBA) should render Section 3(p) objections otiose

1. Whether an approval/agreement with the National Biodiversity Authority (NBA) under the Biological Diversity Act, 2002, precludes the Patent Office from raising objections under Section 3(p) of the Patents Act

2. Whether the claimed herbal composition involves an "inventive step" under Section 2(1)(ja) or is hit by the "traditional knowledge" bar under Section 3(p)

3. Whether post-filing data submitted via affidavit can be used to establish a technical effect not disclosed in the original Complete Specification

The court applied the Patents Act, 1970, specifically Section 2(1)(j) (definition of invention), Section 2(1)(ja) (inventive step), and Section 3(p), which prohibits patenting traditional knowledge or aggregations of known plant properties

It also applied Section 10(4)(a) and (b) regarding the full disclosure of the invention and the best method of performance

Regarding post-filing data, the court relied on the principle from AstraZeneca AB v. Alkem Laboratories Ltd., which holds that such evidence can only confirm a "plausible" technical effect already embedded in the original specification and cannot establish a new effect for the first time

Interpretation of the Biological Diversity Act, 2002, noting that NBA approval is a regulatory mechanism for resource access and does not determine patentability

The Court first rejected the Appellant's argument regarding the NBA, holding that the Biological Diversity Act and the Patents Act operate in distinct spheres; NBA registration is for biological resource regulation and revenue sharing, not for adjudicating patentability

Regarding the merits, the Court found that the Complete Specification (CS) was silent on the classification of five types of asthma and the potential negative side effects of altering herb ratios

Applying AstraZeneca AB, the Court ruled that the Appellant’s affidavit data introduced these features for the first time post-filing, which is impermissible as they were not "implicitly disclosed" in the original CS

The Court noted internal inconsistencies: the CS suggested a 4-herb mixture was as effective as the claimed 6-herb mixture, while the later affidavit claimed the 6-herb ratio was critical to avoid toxicity/side effects

Under the TK Guidelines (Principles 2 and 4), the Court reasoned that combining plants with known therapeutic effects for the same disease is an obvious aggregation of traditional knowledge

The Court dismissed the appeal and upheld the Controller's refusal of the patent