In Versalis SPA vs The Assistant Controller of Patents [(T) CMA (PT) No.2 of 2024], pronounced on August 23, 2024, the Madras High Court evaluated patent application number 7854/CHENP/2011, entitled “A Process of Hydrolysis of Lignocellulosic Biomass”. The Controller had refused the application on several grounds including lack of inventiveness under Section 2(1)(ja), non-patentability under Section 3(d), and insufficiency of disclosure. The Appellant contested this refusal.

The Appellant argued that their invention was novel and inventive over the cited prior art. They asserted that their process solved significant problems associated with conventional methods, such as inefficiencies in hydrolyzing cellulose to its basic sugars and the need for high shear and acidic conditions. They argued that their process, which operates within a temperature range of 20°C to 95°C without requiring inorganic acids or lignin-solubilizing solvents, represented a notable advancement over existing technologies. They also pointed out that their corresponding patent applications had been granted in twenty-three foreign jurisdictions, including EP, which had considered the same prior art on which the Indian refusal was based. The Appellant further submitted that the subject application met all the requirements of Sections 10(4) and 10(5) and was not patent ineligible under Section 3(d) of the Act.

In response, the Controller argued that the impugned application lacked inventive step in view of the cited prior art, specifically documents D1, D3, D5, D9, and D10. Further, it was reaffirmed that the claim lacked clarity, support and ample disclosure, as the complete specification showed insufficient support for the range of 50:50 to 90:10, and the claim was not supported by the description with working examples, thus failing to meet the requirements of Sections 10(4) and 10(5). Additionally, the Controller contended that the invention was merely a use of a known process for hydrolysis and did not produce any unknown technical effect.

The insights provided by the Court into the patentability of this invention based on the various grounds of refusal are as follows:

Upon analysing the prior art, the Court reached the conclusion that none of the cited documents taught or suggested the Appellant’s inventive approach, which involved reintroducing a hydrolyzed solution and marked a significant divergence from the prior art.

Regarding the issue of insufficiency of disclosure, the Court accepted the Appellant’s submission that the Patents Act does not mandate providing examples for every possible variation within the claimed range. The Court found that the Appellant’s specification adequately met these requirements, as it sufficiently detailed the process of contacting the feedstock with the solvent and maintaining optimized conditions.

The Court remarked that the law in this issue is well-established: providing a clear disclosure of at least one method for carrying out the invention is sufficient, provided it enables a person skilled in the art to replicate the invention without undue experimentation. The Court supported this view by referencing the following key decisions:

• FDC Ltd. vs Sanjeev Khandelwal [MANU /IC/0009/2014] wherein it was held that while Section 10(4) requires a complete specification to describe the invention in detail and to disclose the best method for performing it, it is not necessary for the claims to be representative of the best method.
• Tata Global Beverages Limited, West Bengal vs Hindustan Unilever Limited, Maharashtra, India and Anr. [CDJ 2012 IPAB 136] wherein the IPAB held that Section 10(5) does not obligate the provision of examples across the entire range claimed and that only the disclosure of the best working example is mandatory.
• Farbwerke Hoeschst Aktiengesellschaft Vormals Meister Lucius & Bruning, A. Corporation vs Unichem Laboratories [AIR 1969 Bom 255]wherein it was clarified that the specification and claims are directed to individuals with a high level of expertise in the relevant field in view of which it is not necessary to describe processes that are part of common general knowledge, as such individuals can refer to technical literature to understand and implement the invention.

Regarding the objection under Section 10(5), the Court remarked that it is adequate if the claims are reasonably aligned with the description, rather than being an exact match. Therefore, the Court rejected the Controller’s conclusion, which was based on a misinterpretation of this statutory requirement.

Regarding the Controller’s rejection on the ground of non-patentability under section 3(d) of the Patents Act, the Court opined that the Controller’s decision that the claimed process was a mere use of a known process of hydrolysis suffered from hindsight bias. The Court referred to the following judgments to clarify the interpretation and application of Section 3(d):

• Natco Pharma Limited vs Pfizer Products Inc.: This case emphasized that an invention cannot be dismissed under Section 3(d) when a particular solution itself was not known prior to the invention.
• Enercon India Ltd. vs Aloys Wobben [2013 SCC OnLine IPAB 91]: This judgment established that obviousness in hindsight does not negate the patentability of an invention. The Court emphasized on the ‘could-would’ approach- “The crucial aspect is not whether the person skilled in the art could have carried out the invention, but whether he would have done so in the expectation of either solving the problem or showing some improvement or advantage.”
• Gandhimathi Appliances Limited vs L.G. Varadaraju [2000 SCC OnLine Mad 1238]: This case highlighted that even if an invention comprises known components or steps, it can still be patentable if it results in a novel use.

The Court also noted that the grant of the corresponding EP application after consideration of the same prior art as had been relied upon by the Indian Patent Office and the grant of a corresponding patent in 23 foreign jurisdictions, could not be overlooked.

In conclusion, the Court allowed the appeal, set aside the impugned order and upheld the patentability of the claimed invention.