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

In brief

The question

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

The court held

The Court held that: (i) NBA approval has no nexus with patentability criteria; (ii) the invention lacks an inventive step under Section 2(1)(ja) as it is an obvious combination of traditionally known ingredients; (iii) the application falls under the Section 3(p) exception for traditional knowledge; and (iv) the Appellant failed to provide a full disclosure or the best method of performance under Section 10(4), as the critical data on ratios and side effects were omitted from the original specification

It also directed

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

01Facts

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

pp. 1-2

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

p. 2

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

p. 3

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

p. 5, 20

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

p. 7

02Issues

i.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

p. 14

ii.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)

p. 16, 30

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

p. 11, 26

03Law Applied

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

p. 1, 30

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

p. 31

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

pp. 26-27

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

pp. 15-16

Provisions in the judgment · 10 · Linked ones open on LawLens

Patents Act, 1970 Section 2 Section 3 Section 10 Section 64

Biological Diversity Act, 2002 Section 3 Section 6 Section 7 Section 8 Section 18 Section 19

04Reasoning

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

p. 16

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

pp. 20-22

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

p. 26, 28

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

p. 12, 29

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

pp. 30-31