In a landmark judgment, the Madras High Court brought significant clarity to the nuances of patent eligibility under the Indian Patent Act, 1970, (the Act) particularly concerning biochemical inventions.

In the case, Novozymes v Assistant Controller of Patents and Designs revolved around patentability of phytase variants with enhanced thermostability.

The Assistant Controller of Patents and Designs (Controller) had initially refused Novozymes’ patent application, invoking Sections 3(d) and 3(e) of the Act which address non-patentability of known substances without significant efficacy enhancement and mere admixtures, respectively. Novozymes challenged this decision, leading to an in-depth examination of these provisions in the context of biochemical substances.

Novozymes argued that Section 3(d) of the Act applies only to “pharmaceutical substances”, relying on precedents like Novartis AG v Union of India. Further, invoking the principle of ejusdem generis (of the same kind), Novozymes contended that the generic expression “and other derivatives of known substance” in Section 3(d) should be limited to derivatives of chemical substances only and not be extended to biochemical substances. Moreover, Novozymes asserted that their invention met the enhanced efficacy requirement through improved thermostability, and that Section 3(e) applies solely to independent claims.

In response, the Controller interpreted “known substance” in Section 3(d) broadly, including both pharmaceutical and biochemical substances. They insisted that enhanced efficacy required proof of improved enzyme activity. Furthermore, the Controller upheld Section 3(e), emphasizing the need for synergy in compositions.

Section 3(d) – Clarifying Applicability to Biochemical Inventions – The Court meticulously examined the two judgements relied by Novozymes and expanded the interpretation of Section 3(d) of the Act, extending its applicability to biochemical substances beyond pharmaceuticals and agrochemicals. The Court emphasized that “enhancement of efficacy” assessment should align with principles set in Novartis’ Supreme Court judgment, avoiding prescribing a one-size-fits-all numerical benchmark for efficacy. Instead, it upheld a flexible approach, evaluating efficacy based on a product’s function, purpose, or utility. This inclusive and nuanced perspective led the Court to validate Novozymes’ phytase variants with improved thermostability, ultimately overturning the Controller’s refusal and granting claims 1-7.

Scope of Section 3(e) – Scope of Applicability – The Court also addressed the applicability of Section 3(e), and further clarified that this section’s applicability is not confined to compositions of known ingredients or limited to independent claims. Thus, the Court upheld the Controller’s decision to deny claims 8 – 11, citing the absence of evidence that the composition offered more than the sum of its parts.

The ruling encourages a flexible approach to patent eligibility assessments in the biotechnology sector. It recognizes the diverse nature of substances, fostering innovation. The reaffirmation of Section 3(e) raises patent eligibility standards, promoting stronger evidence of synergy in compositions. This decision shapes a balanced patent evaluation landscape, impacting current and future innovations.