An order refusing a patent has to explain itself. When the Deputy Controller rejected a crystalline-form application without engaging with the applicant’s expert evidence — and leaned on a document published after the priority date — the Madras High Court set the refusal aside and directed that a different officer decide it afresh.
The application
Intervet International B.V. and the Microbial Chemistry Research Foundation applied for a patent covering solvated and non-solvated crystalline forms of 20,23-dipiperidinyl-5-O-mycaminosyl-tylonolide. The invention was claimed to show enhanced stability, economic significance and technical advancement over the prior art.
The Deputy Controller of Patents & Designs refused it under Sections 3(d) and 3(e) of the Patents Act, 1970 — the provisions excluding new forms of a known substance without enhanced therapeutic efficacy, and mere admixtures resulting only in aggregation of properties. The applicants appealed to the Madras High Court.
The arguments
For the appellants:
- the refusal was arbitrary, lacked sufficient reasoning, and violated the principles of natural justice;
- expert evidence from Dr. Ralf Warrass, demonstrating higher stability over the known prior art, was disregarded;
- the crystalline form delivered significant advancements and was novel — as the Controller himself had acknowledged in the First Examination Report;
- the prior art documents D1 and D2 were improperly relied on, D2 having been published after the priority date; and
- relying on Novartis AG v. Union of India and Regents of University of California v. Union of India, enhanced stability could bear on therapeutic efficacy, and procedural fairness was mandatory.
For the respondent: the refusal was sound — the appellants had failed to demonstrate enhanced therapeutic efficacy as Section 3(d) requires. Citing Novartis, enhanced stability alone does not meet the standard for enhanced therapeutic efficacy. The order, it was said, was reasoned and compliant with natural justice.
What the court held
Justice Abdul Quddhose found the Deputy Controller’s order defective on four counts. It:
- violated the principles of natural justice, being non-speaking and lacking sufficient reasoning;
- ignored the expert evidence and the guidelines for examination of pharmaceutical patents;
- misapplied Sections 3(d) and 3(e) without giving the appellants an opportunity to substantiate their claims; and
- relied on prior art (D2) that was inapplicable, having been published after the priority date.
The court set aside the refusal and remanded the matter, directing:
- re-examination by a different officer, to avoid any potential bias;
- a decision within six months, taking the court’s observations into account; and
- liberty to the appellants to amend their application within statutory limits.
Why it matters
The judgment does not hold that the invention is patentable — the Section 3(d) question remains open for the fresh adjudication. What it establishes is procedural, and applies to every applicant before the Patent Office: a refusal must be a speaking order. It must engage with the expert evidence placed on record, apply the correct prior art, and give the applicant a real opportunity to meet the objection actually being taken.
The direction that a different officer decide the remanded application is the sharper part of the order. It signals that where an order shows the objections were not genuinely considered, remitting it to the same officer is not an adequate remedy.
For applicants, the practical lesson is to build the record early — expert affidavits, comparative stability and efficacy data, and a clear challenge to the dates of any cited prior art. Those are exactly the materials whose neglect made this refusal unsustainable.
The takeaways
- Refusals must be speaking orders — reasoning that engages with the material on record.
- Expert evidence cannot simply be ignored — nor can the pharmaceutical examination guidelines.
- Check the publication date of cited prior art — D2 post-dated the priority date and should not have been relied on.
- Remand went to a different officer — with a six-month deadline and liberty to amend.
Frequently asked questions
What makes a patent refusal order defective? Being non-speaking — failing to give sufficient reasons, ignoring expert evidence on record, misapplying the statutory exclusions, or relying on prior art that is not applicable.
Can prior art published after the priority date be relied on? No — the court held reliance on document D2 was improper because it was published after the priority date of the application.
What did the court order? It set aside the refusal and remanded the application for fresh consideration by a different officer within six months, with liberty to the appellants to amend.
Does enhanced stability satisfy Section 3(d)? That question was left open for fresh adjudication; the respondent relied on Novartis for the position that stability alone does not establish enhanced therapeutic efficacy.