Decision: The appeal was allowed. The impugned order refusing the patent was set aside. The matter was remanded to the Patent Office for fresh consideration in light of the observations made by the Court.
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Introduction
In a notable decision concerning patent protection for new forms of known chemical compounds in the agrochemical sector, the Delhi High Court has emphasised the importance of experimental evidence demonstrating technical advantages of a new crystalline form. The ruling underscores that polymorphism — the ability of a substance to exist in multiple crystal structures — is often unpredictable, and courts must carefully evaluate whether a new form offers genuine improvements over known versions rather than dismissing it as a mere variation.
Factual and Procedural Background
Syngenta Participations AG filed a patent application in India for a specific crystalline monohydrate form of a known fungicide compound used to control plant diseases. This new form was claimed to provide better stability in certain agricultural formulations compared to the previously known anhydrous version. The Indian Patent Office, after examination and hearing, refused the application. Syngenta challenged this refusal by filing an appeal before the Delhi High Court.
The matter was heard by the court, with detailed arguments presented by senior advocates on both sides. The company submitted experimental data and expert evidence to show the practical benefits of the new form, while the Controller defended the rejection primarily on grounds of obviousness and lack of sufficient improvement.
Dispute
The central dispute was whether the new monohydrate crystalline form of the known compound involved an inventive step and whether it qualified for patent protection or fell under the exclusion for new forms of known substances that do not demonstrate enhanced efficacy. The Patent Office took the view that improved thermal stability was an inherent and expected property of such forms and that the applicant had not shown meaningful enhancement in performance. Syngenta argued that preparing a stable and useful new polymorph requires significant research, that the behaviour of different crystal forms is unpredictable, and that their data proved real advantages in formulation stability and reduced issues during agricultural application.
Reasoning and Analysis of the Judge
The COURT highlighted that polymorphism is a complex phenomenon where different crystal arrangements of the same molecule can lead to significantly different physical behaviours, even though the chemical composition remains identical. He referred to scientific literature explaining that it is generally not possible to predict in advance whether a new polymorph will form or what its properties will be.
The court discussed the judgment in F-Hoffmann-la Roche Ltd. & Anr. vs Cipla Ltd., 2015:DHC:9674-DB, where the Division Bench of the Delhi High Court laid down a structured approach for assessing inventive step, including identifying the person skilled in the art, the inventive concept, common general knowledge, differences from prior art, and whether those differences would have been obvious. Justice Gedela also relied upon Agriboard International LLC vs Deputy Controller of Patents & Designs, 2022 SCC OnLine Del 940, stressing that a Controller must properly analyse the prior art, the new invention, and how it would appear to a skilled person, rather than reaching a bare conclusion of obviousness.
On the objection under Section 3(d) of the Patents Act, the court referred to the Supreme Court’s landmark decision in Novartis AG vs Union of India & Others, (2013) 6 SCC 1. While noting that the stricter “therapeutic efficacy” test applies mainly to pharmaceuticals, the judge observed that in the agrochemical field, improvements in formulation stability, handling, and reduced plant toxicity can constitute enhanced efficacy for the purpose of patentability.
The court found that the Controller had not adequately explained why the experimental evidence of superior stability in practical agricultural suspensions was insufficient. It also criticised the reliance on “common general knowledge” without citing specific sources. The judge concluded that the applicant had demonstrated a technical advance through concrete data showing that the new form solved real problems of crystal growth and equipment blockages that occurred with the known form.
Final Decision of the Court
The Delhi High Court allowed Syngenta’s appeal. The order of the Controller refusing the patent application was set aside. The matter was remanded back to the Patent Office for fresh consideration in accordance with the observations made by the court.
Point of Law Settled in the Case
This judgment reinforces that in cases involving new polymorphic forms, patent examiners and courts must give due weight to experimental evidence of improved properties and practical advantages, particularly in agrochemicals. It clarifies that unpredictability of polymorphism and demonstrated technical benefits in formulation stability can support both inventive step and enhanced efficacy under Section 3(d). Mere assertions that a new form is obvious or inherently stable are not enough; the analysis must be evidence-based and reasoned.
Disclaimer: Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
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