The Hon’ble Madras High Court, in the case of the case of Novozymes (“Appellant”) Vs. The Assistant Controller of Patents & Designs (“Controller”), while partly maintaining the impugned order, clarified that Sections 3(d) of the Patent Act, 1970 (“Act”) is not confined solely to pharmaceutical substances and that defining efficacy enhancement need not be restrictive, enabling a more expansive interpretation. The Court also ruled that, Section 3(e) of the Act encompasses all claims involving compositions, even those incorporating novel ingredients, heightening the difficulty of patent acquisition for such compositions.
It was the Appellant’s case that it had applied for a grant of patent to ‘Phytase’ variants with improved thermostability. The application was examined and subsequently refused on the grounds of non-patentability under Sections 3(d) and 3(e) of the Act.
The Appellants, in their appeal, argued that section 3(d) of the Act applies only to pharmaceutical substances, based on legal precedents and that their claimed invention enhanced the thermostability of phytase, which improved its overall effectiveness. The Appellants also contended that Section 3(e) of the Act should apply only to independent claims, not dependent claims.
The Controller’s position was that Section 3(d) of the Act applied to all known substances, including biochemical ones like phytase. The Controller also argued that the enhancement of efficacy should be demonstrated in terms of enzymatic activity. Regarding section 3(e), the Controller maintained that it was not limited to independent claims and that the composition should exhibit synergy between its ingredients.
The Hon’ble Madras High Court, concurring with the Controller, ruled that Section 3(d) of the Act is not confined to pharmaceutical substances; as it applies to all known substances, including biochemical ones like phytase. The Court also clarified that the enhancement of efficacy does not need to be limited to a specific type of efficacy. Further, the Court did not find that the claimed invention fell within the scope of the explanation to section 3(d), and the principle of ejusdem generis did not apply in this case. Additionally, the court held that even a marginal improvement in efficacy could satisfy the patentability requirement but should still have a meaningful impact on the product’s overall efficacy. As regards Section 3(e), the Court established that Section 3(e) is not limited to compositions formed by aggregating known ingredients and can apply to all composition claims, even those containing new ingredients.
In conclusion, the Court maintained the Controller’s refusal decision not to grant claims 8-11 under section 3(e) of the Act due to the absence of evidence that the composition was more than the sum of its parts. This case clarifies that Section 3(d) of the Act applies to biochemical inventions and that the enhancement of efficacy should be examined broadly. It also expands the application of section 3(e) to all composition claims and raises the bar for patentability in this regard.
Novozymes (“Appellant”) vs. The Assistant Controller of Patents & Designs (“Controller”)