Procedural Fairness and working examples: Bayer Prevails in Patent Dispute

n a recent decision dated 13th March 2024, the High Court of Delhi, in the case of Bayer Pharm Aktiengesellschaft versus The Controller General of Patents and Designs, ruled in favor of the appellant Bayer Pharm Aktiengesellschaft (Bayer) in a patent dispute. The case, bearing the reference C.A.(COMM.IPD-PAT) 255/2022, revolved around the rejection of Bayer's patent application under Section 15 of the Patents Act, 1970, primarily on the grounds of Sections 3(e) and 3(i) of the Act.

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Background of the Case

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The subject application, filed by Bayer, encompassed a patent claim for a specific composition. The rejection, as outlined in the impugned order dated 16th May 2012, was primarily based on the Controller General's view that the composition did not demonstrate a synergistic effect over prior art and was construed as a method of treatment under Section 3(i) of the Act.

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Appellant's Arguments

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Bayer contended that they were not provided a fair opportunity to address the objection under Section 3(e) of the Act as it was not explicitly mentioned in the hearing notice. Moreover, they emphasized that the patent application pertained to a composition, not a method of treatment, thus challenging the basis of rejection under Section 3(i) of the Act.

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Respondent's Submissions

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On the other hand, the Respondent argued that the objections raised were valid, supported by working examples provided in the application, which demonstrated the claimed invention as a method of treatment. They asserted that the prescribed dosing regimen indicated a method of treatment rather than a mere composition.

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Court's Analysis and Findings

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Upon careful consideration, the Court found merit in Bayer's contentions. It ruled that the failure to communicate the objection under Section 3(e) of the Act in the hearing notice infringed upon procedural fairness principles. Additionally, the Court opined that the claim, as articulated, primarily pertained to a composition, not a method of treatment, thereby negating the application of Section 3(i) of the Act.

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Working Examples:

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The Court observed that in patent law, the claims of a patent define the boundaries of the patent protection. That is, they set out the legal limits of what the patent covers. The claims must be clear, specific, and supported by the description within the patent application. They are the most critical part of a patent application because they determine the extent of protection granted by the patent. Working examples, on the other hand, are provided in the subject application to demonstrate the practical implementation of the invention. These examples are intended to show that the invention is feasible and workable and how it can be carried out in practice. They provide support and understanding for the claimed invention, showing that it is not just a theoretical concept, but has practical applicability. Thus, while working examples are essential for demonstrating 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.

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Conclusion and Directions

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In light of the above findings, the Court set aside the impugned order and remanded the matter to the Respondent for de novo consideration. The Court directed the Respondent to provide a fresh hearing notice, clearly delineating any objections. Furthermore, it emphasized that the decision must be rendered within a specified timeframe, uninfluenced by any observations made in the impugned order.

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Implications:

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This decision serves as a significant precedent emphasizing the importance of procedural fairness and accurate interpretation of patent claims. It underscores the necessity for clear communication of objections and adherence to legal principles in patent examination procedures. Also, it clarifies that in patent law, the claims define the scope of protection, while working examples demonstrate feasibility. However, the scope is determined solely by the claims, interpreted alongside the description and examples.

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In conclusion, the High Court of Delhi's ruling in favor of Bayer Pharma Aktiengesellschaft marks a victory for procedural fairness and clarity in patent adjudication processes.

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