In a recent ruling concerning pharmaceutical patents, the Calcutta High Court set aside a decision by the Controller of Patents for erroneously conflating the distinct legal standards for patentability of an invention. The judgment underscores ongoing concerns regarding inconsistencies in the examination of pharmaceutical composition claims, particularly where the statutory criteria are misapplied.

Facts:

The Appellant filed a patent Application No. 3996/KOLNP/2010 titled “Methods and Compositions for oral administration of proteins for treatment of diabetes”. The invention disclosed an oral pharmaceutical composition comprising insulin as the active protein component, along with two protease inhibitors (Aprotinin and SBTI) – to prevent enzymatic degradation during oral administration. The composition may additionally include EDTA derivatives and Omega-3 fatty acids to enhance bioavailability.

The Deputy Controller refused the application citing lack of inventive step and non-patentability. Aggrieved by the decision, the Appellant filed an appeal before the Calcutta High Court.

Key Issues:

• Whether the alteration of prior art combinations without prior intimation was permissible i.e. initially in the hearing notice referring prior arts D1 to D4 but basing the final decision solely on D1 and D4, thereby ignoring D2 and D3,
• Whether adequate consideration was given to the expert evidence adduced and technical data submitted, and
• Whether the application of the therapeutic efficacy test during examination was legally tenable.

Court observations and findings:

• Citing prior judgments such as Guangdong Oppo v. Controller of Patents, the Court emphasized that mosaicking of prior art requires a clear and logical thread and altering the combination of cited references at the final stage—without prior notice—violates the principles of natural justice and deprives the Applicant of a fair opportunity to respond.
• The Court criticized the Controller for disregarding expert affidavits and technical submissions, and reaffirmed that such omission violates procedural fairness, especially in a matter remanded by the Court with explicit directions to consider all evidence.
• The Court observed a significant flaw in the impugned order, noting that while the hearing notice was issued under a particular provision of the Patents Act, the final decision was based on an entirely different provision. This inconsistency was deemed legally untenable. The Court reaffirmed that said two provisions (i.e., Sections 3(d) and 3(e)) serve distinct purposes: Section 3(d) applies to known substances and requires demonstration of enhanced therapeutic efficacy, whereas Section 3(e) pertains to compositions and demands evidence of synergistic effect, not efficacy. The Court found that applying Section 3(d)’s efficacy test under Section 3(e) constitutes a fundamental legal error.

Conclusion:

The Judge set aside the impugned order, and remanded the matter for fresh consideration by a different Examiner. The Court directed that all expert evidence and technical submissions be duly evaluated and emphasized that any determination on patentability must be supported by cogent, reasoned findings in accordance with law.