Patent Eligibility of Composition Claims under Section 3(i)

Patent Eligibility of Composition Claims under Section 3(i)Recently, the Delhi High Court in Bayer Pharm Aktiengesellschaft (“appellant”) v Controller General of Patents (“respondent”) [2024:DHC:2395] elucidated the role of working examples in patent applications and the ambit of ‘method of treatment’ exclusion with regard to composition claims. Bayer’s patent application related to the multiphase contraceptive formulation, wherein the independent claim recited a composition comprising components having their unit numbers. The respondent Controller refused the application by reasoning that the claims lacked a synergistic effect of the composition over the prior art and that the claimed composition was a method of treatment in the form of daily dose units as indicated in the specification. Thus, the Controller found the claims to fall within the scope of section 3(e) and section 3(i) of the Indian Patents Act, respectively.

The appellant challenged the Controller’s rejection order, and the grounds of appeal were twofold. As the objection of synergistic effect under section 3(e) was not mentioned in the hearing notice, it was contended that the appellant was deprived of a fair opportunity to prepare a defence and deal with the objection never formally raised. Secondly, the appellant argued that the independent claim of the subject application was directed towards a product (a composition) rather than a process or a method of treatment barred under section 3(i), and the Controller failed to discern this crucial distinction.

As per the respondent, working examples in the specification demonstrated that the claimed invention pertained to a method of treatment. The respondent further asserted that the independent claim described a composition designed for administration in accordance with the days of the menstrual cycle – one tablet per day. It was contended that section 3(i) would attract, as the patent specification outlined not merely a composition but a dosing regimen that was intrinsically linked to the treatment of menstrual cycle disorders.

Considering the arguments of both sides, the court first reaffirmed the fundamental principles of natural justice. The court noted that non-communication of objection under Section 3(e) was violative of well-settled procedural fairness. Citing the Indian Patent Office’s circular, the court reiterated that the Controller was obliged to enumerate all pending objections in the hearing notice. Therefore, the court held that the omission to communicate the objection under Section 3(e) was a procedural irregularity that impaired the appellant’s ability to defend its application adequately.

The court then addressed the bone of contention in the instant case. On perusing the claimed composition and its representation within the application, the court deduced that the claim at issue pertained exclusively to a product rather than a process. The court’s finding was based on the rationale that mere recitations of the unit numbers of the components in the independent claim would not render it a method of treatment, a patent-ineligible matter, under section 3(i). Particularly, the claim did not refer to a disease, treatment, or mode of administration of the composition.

The court added that interpreting the scope of the claims was imperative while examining a patent application. The court distinguished the role of claims and working examples in determining the scope of a claimed invention or patent. Claims are the most critical part of a patent application, as they delineate the legal boundaries of patent protection. However, working examples are included in the patent application to demonstrate the practical implementation of the invention. They exemplify that the claimed invention is not just a theoretical concept but has practical applicability.

Thus, while working examples are essential for displaying the feasibility and workability of an invention, they do not define the patent’s scope. The scope is determined by the claims, which must be interpreted in light of the description and any examples provided. Based on the above analysis, the court held the respondent’s reliance on the working examples and application of section 3(i) was misplaced. Consequently, the appeal was allowed, and the matter was remanded to the Patent Office for fresh consideration.

Apropos, the court quoted last year’s decision in Nestle v Controller, where the expression ‘composition comprising X directed towards treatment’ was held to be used only for defining the composition, not a method of treatment. In the present case, the court ruled that the composition claims having unit numbers of its components are patentable and not hit by section 3(i). Such progressive pronouncements would indeed have a positive bearing on many pharmaceutical applications.

Authors: Manisha Singh and Neha Ruhela

First Published by: Lexology here