The appellants, Intervet International B.V. and Microbial Chemistry Research Foundation, filed an appeal against the Deputy Controller of Patents & Designs for refusing a patent application for solvated and non-solvated crystalline forms of 20,23 dipiperidinyl-5-O-mycaminosyl-tylonolide. The invention was claimed to exhibit enhanced stability, economic significance, and technical advancements over prior art. The patent was refused under Sections 3(d) and 3(e) of the Patents Act, 1970, which address non-patentable inventions based on the lack of enhanced therapeutic efficacy or mere aggregation of known substances.

Arguments Raised
Appellants:
o The refusal was arbitrary, lacking sufficient reasoning, and violated principles of natural justice.
o Expert evidence by Dr. Ralf Warrass was disregarded, despite demonstrating higher stability of the invention over known prior arts.
o The crystalline form provided significant advancements and was novel, as acknowledged by the Controller in the First Examination Report.
o Prior arts (D1 and D2) were improperly considered, with D2 being published after the priority date.
o The appellants cited judgments, including Novartis AG vs. Union of India and Regents of University of California vs. Union of India, to argue for enhanced stability’s link to therapeutic efficacy and procedural fairness.

Respondent:
o Defended the refusal, arguing the appellants failed to demonstrate enhanced therapeutic efficacy as mandated under Section 3(d).
o Cited the Novartis case, emphasizing that enhanced stability alone does not meet the required standard for enhanced therapeutic efficacy.
o Asserted the order was reasoned and compliant with natural justice.

The Court held that the order passed by the Deputy Controller:
• Violated principles of natural justice as it was non-speaking and lacked sufficient reasoning.
• Improperly ignored expert evidence and guidelines for pharmaceutical patent examination.
• Misapplied Section 3(d) and 3(e) without allowing the appellants an opportunity to substantiate their claims.
• Relied on prior art (D2) that was inapplicable due to its publication date.

The court set aside the refusal order and remanded the matter for fresh consideration. It directed:
• A re-examination by a different officer to avoid potential bias.
• A decision within six months, considering the court’s observations.
• Permission for the appellants to amend their application within statutory limits.

The court emphasized the necessity of reasoned decisions, adherence to procedural fairness, and compliance with patent law. The appellants were granted an opportunity to substantiate their claims before a fresh adjudication.

Details of the Case
Case Title: Intervet International B.V. and Microbial Chemistry Research Foundation Vs The Deputy Controller of Patents & Designs, Indian Patent Office – CMA (PT) No. 119 of 2023
Court: Madras High Court
Judge: Hon’ble Mr. Justice Abdul Quddhose