When the File Moved On, the Order Stood Still: The Delhi High Court Remands Medilabo on Section 3(i)

By Lucy Rana and Huda Jafri

The Delhi High Court in Medilabo RFP Inc. v. Controller of Patents[1] set aside a refusal under Section 3(i) of the Patents Act, 1970 concerning a pharmaceutical invention for neurodegenerative diseases, The Court’s intervention turned on a more fundamental principle of patent adjudication: the Controller must decide an application on the basis of the claims as they stand on the date of the order and must deal with every objection raised in the hearing notice through reasoned findings.

In the present case, the refusal was based on claim features that had already been deleted through post-hearing amendments, while other live objections under Sections 2(1)(ja), 3(d), and 59 remained unaddressed. The Court therefore set aside the order and remanded the matter for fresh consideration on the correct record, leaving the substantive contours of Section 3(i), particularly its interface with pharmaceutical composition claims, open for determination in an appropriate case.

1. Background

   The application and original claims

   Medilabo RFP Inc. filed a patent application directed to a pharmaceutical formulation for treating or preventing neurodegenerative diseases. The invention combined rifampicin and resveratrol, with original claims framed around a trans-nasal administration regimen and body-weight-adjusted dosing.

   Claims 3 to 13 were primarily directed to a therapeutic/prophylactic regimen involving administration over a specified period.

   After the hearing dated 6 October 2023, the applicant filed amended claims. The amended Claim 1 removed both (i) the mode of administration and (ii) explicit reference to the combination, and was presented as a product/composition claim. Claim 2 was directed to a kit comprising the composition.

2. The Refusal Order

   The Assistant Controller refused the application under Section 3(i), holding that despite amendments, the specification and examples continued to disclose a therapeutic regimen rather than a pure composition.

   The Controller relied on experimental disclosures involving administration in animal models and extrapolation to human therapeutic use, concluding that the invention remained a method of treatment in substance.

   However, two procedural issues arose:

   1. The reasoning appeared to rely on features removed from the amended claims; and
   2. Objections under Sections 2(1)(ja), 3(d), and 59 raised in the hearing notice were not adjudicated.

   Statutory Context: Section 3(i)

   Section 3(i) excludes from patentability:

   “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals…”

   The provision is directed at processes or methods of treatment, not pharmaceutical products per se. Composition claims are ordinarily examined under Sections 3(d), 3(e), and the general requirements of novelty and inventive step.

3. Core Issue: Which Claim Was Decided?

   The Court identified a fundamental defect: the refusal order was effectively based on the original claim set, despite the existence of amended claims on record.

   Issue	Controller’s Approach	Court’s Concern
   Claim version considered	Original claims with dosage and administration features	Amended claims without such features
   Basis of reasoning	Treatment regimen inferred from specification and examples	Decision not aligned with operative claims
   Legal defect	None addressed in amended claim context	Decision on incorrect record

   The Court held that this amounted to a jurisdictional and procedural error, as the adjudication was not grounded in the operative claims.

4. Failure to Address All Objections

   Relying on Adama Makhteshim Ltd v. Controller of Patents[2], the Court reiterated that all objections raised in the hearing notice must be decided.

   In this case, objections under:

   • Section 2(1)(ja) (inventive step)
   • Section 3(d) (enhanced efficacy requirement)
   • Section 59 (allowability of amendments)

   were not addressed at all.

   The Court held that selective adjudication undermines both procedural fairness and appellate efficiency, as it deprives the appellate court of the Controller’s reasoning on all live issues.

5. What the Court Did Not Decide

   Importantly, the Court did not decide:

   • Whether the amended Claim 1 is a true composition claim;
   • Whether the specification still characterises the invention as a method of treatment; or
   • Whether Section 3(i) is ultimately attracted on merits.

   These issues were expressly left open for reconsideration by the Controller on remand.

6. Practical Takeaways

   For patent applicants

   Post-hearing amendments must be clearly mapped to specific objections. Ambiguity in the amendment record may lead to the Controller relying on earlier claim language.

   For pharmaceutical patents

   Deleting dosage language may not be sufficient if the specification continues to disclose only therapeutic administration. The substance of disclosure remains relevant under Section 3(i).

   For appeals

   Failure to address all objections in the hearing notice is now a strong independent ground for remand, alongside misapplication of the operative claim set.

7. Conclusion

   The decision reinforces two procedural pillars of Indian patent prosecution:

   1. The Controller must decide on the correct and current claim set; and
   2. Every objection raised must be independently and expressly adjudicated.

   While the substantive contours of Section 3(i) remain unresolved, the judgment strengthens procedural discipline in patent refusal orders and ensures that prosecution is assessed on the actual record rather than an outdated one.

[1] (C.A.(COMM.IPD-PAT) 16/2024)

[2] (C.A. (Comm IPD-PAT) 167/2022)