The Hon'ble High Court of Delhi vide its order dated March 13, 2024, delivered a significant ruling in the case of Bayer Pharm Aktiengesellschaft versus The Controller General of Patents and Designs. The Court's judgment addresses pivotal aspects of patent law and procedure under the Indian legal framework, particularly focusing on the nuanced interpretation of Section 3(e) and 3(i) of the Patents Act, 1970. The Hon'ble Court allowed the appeal filed by appellant and held that the working examples provided in a patent specification are only to demonstrate the workability of the invention and do not define the scope of the patent. The Court ruling emphasized the paramount importance of precise claim interpretation, guided by the description and examples provided in the patent application, thereby reshaping the landscape of patent enforcement and innovation protection in India.
Bayer Pharm Aktiengesellschaft versus The Controller General of Patents and Designs
Bayer Pharm Aktiengesellschaft (hereinafter referred to as “appellant”) filed a patent application, having its application number 5818/DELNP/2006, seeking protection for a multiphase contraceptive formulation. However, the Controller rejected the appellant's application under Section 15 of the Patent's Act, 1970, primarily relying on Section 3(e) and 3(i) of the Act.
The Controller of Patents and Designs vide order dated May 16, 2012 refused the appellant's patent application, citing objections under sections 3(e) and 3(i) of the Patents Act 1970. The rejection as outlined in the impugned order dated May 16, 2012 was based on the failure to demonstrate the synergistic effect of the composition over prior art, and establish that the invention is not a method of treatment under Section 3(i).
Contentions of the Appellant
The appellant contended that the procedural fairness was compromised as they were not afforded a fair opportunity to address objections u/s 3(e) of the Act, and the specific ground was not raised in the hearing notice and the lacuna undermines procedural fairness. Further, there was critical misinterpretation of section 3(i) wherein the respondent failed to differentiate between a composition and a method/process treatment.
Contentions of the Respondent
The respondent countered by asserting that the examples conclusively illustrate that the claims of invention relates to a method of treatment, with Claim 1 specifically describing a composition designed for administration. The respondent pointed out that the specification outlined both the composition and a dosing regimen intricately linked to treatment of menstrual cycle disorders.
Furthermore, the respondent countered that the appellant's classification effectively rendered it as a method of treatment, thereby falling within the exclusion specified u/s 3(i) of the Patents Act.
COURT's ORDER
Upon considering contentions from the appellant and the respondent, the Hon'ble Court determined that non communication of objection u/s 3(e) breached the principles of natural justice and constituted procedural irregularities. Additionally, the Court noted deficiencies in the order passed by the Ld. Controller lacking substantive basis.
Concerning Claim 1, the Court observed that it pertained solely to a product rather than a process. Blunt recitations of the unit numbers of component in Claim 1 did not preclude it from patent protection u/s 3(i). Notably, there was neither any reference to disease/treatment nor to any modes/manner.
The Court underscored that patent claims set out the legal limits and extent of protection granted, whereas working example reveals practical implementation of the invention. The working examples illustrated scalability, feasibility, workability and how it can be exercised in practice.
Accordingly, the working example does not define patent scope but bestow support and understanding for the claimed invention. Hence, the rational for applying section 3(i) of the Patent Act was deemed misplaced.
In addition to above, the court cited a prominent case of Societe Des Produits Nestle SA v. The Controller of Patents and Design and Anr. The Court referred to the Manual of Patent Office, Practice and Procedure, and held that the claims in respect of the composition are patentable, and not governed by Section 3(i) of the Act.
Analysis
The Delhi High Court emphasized that the claim 1 did not render the application non-patentable and allowed the appellant's appeal. The Court set aside the order by the respondent and directed the respondent to provide the appellant a fresh hearing delineating the objections.
Ambiguity in Section 3(i)
While the Hon'ble Delhi High Court's judgement in Bayer Pharm Aktiengesellschaft versus The Controller General of Patents and Designs brings clarity to various aspects of patent law, particularly concerning Section 3(e), it also sheds light on the challenges posed by the interpretation of Section 3(i). The Court's thorough analysis underscores the significance procedural fairness and substantive examination in patent proceedings. However, the ambiguity surrounding Section 3(i) highlights the complexity of distinguishing between patentable compositions and excluded methods of treatment, As the legal landscape evolves, addressing this ambiguity will be crucial to ensure a balanced approach that promotes innovation while safeguarding public health interest.
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