Delhi High Court Clarifies Scope of Section 3(i), Rules Pharmaceutical Composition is Patentable, Not a Non-Patentable 'Method of Treatment'

New Delhi: In a significant ruling for pharmaceutical patent applicants, the Delhi High Court has held that a claim for a drug composition is not barred from patentability under Section 3(i) of the Patents Act, 1970 , merely because its intended purpose is therapeutic. Justice Tejas Karia set aside an order by the Controller of Patents that had rejected an application for a drug for neurodegenerative diseases, emphasizing that the scope of an invention must be determined by the claims, not its end-use.

The court remanded the matter back to the patent office for fresh consideration, directing the Controller to assess the application based on the final amended claims and to address all grounds of objection.

Background of the Case

The case, MEDILABO RFP INC vs The Controller of Patents , involved an appeal against the Controller's decision to refuse Patent Application No. 202117034705. The application was for a "PROPHYLACTIC OR THERAPEUTIC DRUG FOR NEURODEGENERATIVE DISEASES," specifically a composition containing rifampicin and resveratrol compounds.

The Controller rejected the application, arguing that the invention was essentially a "method of treatment" and thus not patentable under Section 3(i) of the Patents Act. The Controller reasoned that the claims were implicitly directed towards a dosage regimen and a specific mode of administration, which constitutes a method of treating a disease.

Arguments of the Parties

Appellant's Submissions (MEDILABO RFP INC): - The counsel for Medilabo argued that the Controller fundamentally misconstrued the invention. They contended that the claim was for a product (a drug composition and a kit), not a process or "method of treatment."

- It was highlighted that Section 3(i) is specifically applicable to methods and processes, not to tangible compositions or products.

- The Appellant pointed out a critical error in the Controller's decision-making: the refusal was based on earlier versions of the claims which mentioned dosage and "trans nasal administration." These details were intentionally deleted in the final, post-hearing amended claims to clarify that the invention lay solely in the unique composition of the two compounds.

- Citing precedents like Bayer Pharma v. Controller of Patents and Societe Des Produits Nestle SA v. Controller of Patents , the Appellant argued that the purpose or preamble of a claim (e.g., "for a neurodegenerative disease") does not limit its scope unless essential to define the invention's structure.

Respondent's Submissions (The Controller of Patents): - The Controller maintained that when the claims are read along with the complete specification and working examples, it becomes clear that the invention's essence is a dosage regimen. - It was argued that the composition's technical effect is only realized when administered in a specific dosage over a period, making it a method of treatment in disguise. - The Respondent submitted that even with the amendments, the core of the invention remained a treatment method, which is explicitly barred by Section 3(i).

High Court's Analysis and Findings

Justice Tejas Karia sided with the Appellant, finding the Controller's order to be unsustainable. The court's reasoning was based on a clear interpretation of patent law principles.

Focus on Claims, Not End-Use: The court underscored that the scope of an invention is defined by its claims, as mandated by Section 10(4)(c) of the Act. The final amended claim was unequivocally for a "prophylactic or therapeutic drug composition ."

> In a key observation, the court noted: “The learned Controller in the Impugned Order has not provided the details as to how the claimed invention is a composition and not a method of treatment. The learned Controller has not specified from the specification of the Subject Application that how the boundaries of the claim extend to the ‘method of treatment’.”

Error in Considering Outdated Claims: The judgment found a manifest error in the Controller's reliance on earlier, unamended claims. The court observed that the Controller incorrectly focused on the "trans nasal administration" and dosage regimen mentioned previously, despite the Appellant having explicitly removed this language to overcome the objection.

Precedent and Legal Principles: The court extensively relied on its previous judgments in Bayer Pharma and Societe Des Produits Nestle SA , reaffirming the principle that composition claims are not hit by Section 3(i). It also cited the University of Miami case, which held that using the expression "composition for the treatment" in a claim's preamble does not automatically render it a non-patentable method of treatment.

> Citing Bayer (supra) , the Court stated: “mere recitations of the unit numbers of the components in claim 1 cannot render it ineligible for patent protection under Section 3 (i) of the Act... The scope is determined by the claims, which must be interpreted in light of the description and any examples provided. The reasoning for applying Section 3 (i) of the Act to the subject application is therefore, misplaced.”

Failure to Address All Objections: The court also criticized the Controller for dismissing the application solely on the Section 3(i) ground while leaving other objections (under Sections 2(1)(ja), 59, and 3(d)) unaddressed. Citing Adama Makhteshim Ltd v. The Controller of Patents & Designs , the judgment reiterated that the Controller must examine and decide on all grounds of objection.

Final Decision and Implications

The High Court set aside the Controller's refusal order dated December 21, 2023, and remanded the patent application for a fresh examination. The court directed that a new hearing be granted to the Appellant and a decision be made on merits, in accordance with the law, within six months, without being influenced by the court's observations.

This judgment provides crucial clarity for inventors in the pharmaceutical sector, reinforcing the distinction between a patentable product (composition) and a non-patentable process (method of treatment). It serves as a strong reminder to the Patent Office to base its decisions on the precise wording of the final claims submitted for adjudication rather than on their intended application or on outdated versions of the claims.