Court Clarifies Patent Eligibility Criteria for Biochemical Inventions
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.
Court Overturns Patent Refusal Due to Inadequate Obviousness Evaluation
In Kuraray Co. Ltd. and Mebiol Inc. v The Assistant Controller of Patents & Designs, The Patent Office, the Madras High Court ruled in September that the Assistant Controller of Patents & Designs’ (Controller) refusal order lacked merit due to insufficient reasoning.
Kuraray Co. Ltd. and Mebiol Inc. (appellants), filed a patent application for an invention titled, “film for plant cultivation”, which related to a process involves using polyvinyl alcohol film (PVA film) of specification in plant cultivation. The Controller rejected the application. The Court specifically found the Controller’s reasoning insufficient in providing the obviousness of the subject matter, based on the information available in the claimed closest prior art, a single citation.The Court cited a precedent from the case, Agriboard International v The Controller of Patents and Designs; underscoring three key principles for evaluating obviousness: analyzing the invention disclosed in the prior art, assessing the invention disclosed in the application, and determining how the subject invention would be perceived as obvious by a person skilled in the art.Notably, the Court specified that if the identified prior art addresses a different problem, it would not lead a person skilled in the art to arrive at the claimed invention based on said document.Ultimately, the Court ruled in favour of the appellants, Kuraray Co. Ltd. and Mebiol Inc, overturning the refusal decision and allowing the appeal, subject to further amendments to the claims.
Calcutta High Court Questions Controller’s Rejection of Fungicidal Treatment Method
In May, in an appeal made by Decco Worldwide Post Harvest Holdings B.V & Anr (Decco), the Calcutta High Court criticized a rejection order issued by the Assistant Controller of Patents and Designs (Controller).
Court Questions Controller’s Rejection of Fungicidal Treatment Method
In May, in an appeal made by Decco Worldwide Post Harvest Holdings B.V & Anr (Decco), the Calcutta High Court criticized a rejection order issued by the Assistant Controller of Patents and Designs (Controller). Decco had applied for an Indian patent for an invention of a fungicidal treatment method to prevent leaf disease that infects banana plants.
The Court took note of the lack of reasoning by the Controller and their failure to appreciate the facts presented by the Decco. Specifically, the Court was perplexed and questioned the Controller’s lack of clear explanation for categorizing the invention, a fungicidal treatment method, as a non-patentable subject matter under section 3(h) of the Act since it deals with the patentability of methods of agriculture and horticulture, not plant treatment methods.
Delhi High Court Critiques Non-Speaking Patent Refusal
In late May, the Delhi High Court issued an order that yet again condemned a non-speaking refusal decision by the Controller of Patents and Designs (the Controller). The Court was hearing an appeal filed by Huhtamaki Oyk and ANR (Huhtamaki) against
the refusal decision, which merely reproduced information already on record. Allowing the appeal, the Court emphasized the need for reasoned orders and application of mind, calling out the cut-and-paste job in this specific refusal decision.
Additionally, the Court criticised the laconic manner in which Controllers are deciding patent applications, forcing patent applicants to approach the Court thus wasting precious time of the limited patent term otherwise available for the patentee.