Novozymes Vs. Assistant Controller Of Patents & Designs, (T) CMA (PT) No.33 of 2023 (OA/6/2017/PT/CHN)

Summary

An appeal was filed under Section 117-A of the Patents Act, 1970, seeking to set aside the impugned order dated 15.11.2016 of the Assistant Controller of Patents & Designs and obtain a patent for the Indian patent application (application no. 5326/CHENP/2008). The case revolves around an invention initially titled “Phytase Variants” and subsequently amended to “Phytase Variants with Improved Thermostability.” Justice Senthil Kumar Ramamoorthy, while partially setting aside the impugned order concerning the rejection of claims, made two critical determinations:

• It was established that the term “known substance” in Section 3(d) applies to biochemical substances as well.
• The composition claims 8 to 11 were deemed to fall under Section 3(e) because the composition was considered a substance resulting from the mere combination of ingredients.

Issue Raised In The Case

The primary issues in this case revolved around the interpretation of Section 3(d) and Section 3(e) of the Patents Act:

• Section 3(d): Whether the term “known substance” in Section 3(d) applies only to pharmaceutical substances, or does it encompass biochemical substances like phytase?
• Section 3(d): Whether improved thermostability should be considered an enhancement of efficacy?
• Section 3(e): Whether Section 3(e) applies only to compositions formed by the aggregation of known ingredients, or can it be applied to composition claims for substances with individual components that meet patent requirements?

Appellant’s Arguments

Novozymes argued that Section 3(d) is not limited to pharmaceutical products and that biochemical substances like phytase fall within its scope. They contended that improved thermostability enhances the known efficacy of phytase, as it enables easier production and storage in pellet form. Novozymes also asserted that Section 3(e) does not apply to composition claims, especially those dependent on independent claims like their phytase variants.

Respondent’s Arguments

The Respondent argued that Section 3(d) primarily applies to pharmaceutical products and that enhanced efficacy should be limited to enhanced enzymatic activity in the case of enzymes like phytase. They claimed that improved thermostability is insufficient to establish enhanced efficacy. Regarding Section 3(e), the Respondent contended that composition claims must exhibit properties beyond the aggregation of their components to be eligible for a patent.

Judgment

The IPAB issued a comprehensive judgment, addressing each of the appellant’s and Respondent’s arguments:

• The IPAB clarified that Section 3(d) applies not only to pharmaceutical substances but also to biochemical substances like phytase. The term “known substance” is not restricted to pharmaceuticals. The Court referred to Novartis AG v. Union of India, (2013) 6 SCC 1, wherein it was held that the amendment of Section 3(d) by the Patents (Amendment) Act, 2005 was primarily intended to deal with pharmaceutical products and agro-chemical products.
• They determined that enhanced efficacy for biochemical substances could extend beyond increased enzymatic activity, especially when factors like improved thermostability lead to easier production and storage.
• The IPAB held that Section 3(e) does not necessarily apply only to compositions formed by aggregating known ingredients; instead, it applies to substances where the composition is merely the sum of its parts.

Analysis

The IPAB’s judgment in the Novozymes case provides valuable insights into the interpretation of Section 3(d) and Section 3(e) of the Patents Act. It establishes that these sections are not limited to pharmaceutical products but also encompass biochemical substances, expanding the scope of patent eligibility.

Moreover, the judgment clarifies that enhanced efficacy for biochemical substances can encompass factors like improved thermostability, offering flexibility in patent applications for enzymes and similar substances. In addition, the decision affirms that Section 3(e) applies not only to compositions formed by aggregating known ingredients but to substances where the composition adds value beyond the individual components.

Overall, this case sets a precedent for the patenting of biochemical substances and composition claims, providing clarity on the interpretation of crucial sections of the Patents Act and offering more opportunities for innovation in the field of biochemistry.