Introduction

The Delhi High Court’s recent decision in Bayer Pharm Aktiengesellschaft v. The Controller General of Patents and Designs [1] reinforced the principle that the legal limits and scope of a patent are defined by its claims and not by the working examples provided in the application. This judgment is significant as it clarifies that working examples serve to demonstrate the feasibility of the invention but do not determine the extent of patent protection. This case sets a crucial precedent for how patent applications should be evaluated in India, ensuring that the focus remains on the claims when defining the scope of a patent.

Background of the Case

Bayer filed the Indian patent application No. 5818/DELNP/2006, titled “Pharmaceutical Composition for the Treatment of Metabolic Disorders”, relating to a novel pharmaceutical composition designed to treat metabolic disorders by combining multiple active ingredients.

The Indian Patent Office rejected the application on two main grounds, Section 3(e) and Section 3(i) of the Indian Patent Act, 1970 (as amended):

Section 3(e): The Applicant failed to substantiate the arguments to provide synergistic effect of the composition over the cited documents. The Controller held that the composition was merely an admixture resulting in the aggregation of the properties of the components, meaning it did not show any enhanced effect due to the combination of ingredients beyond their individual effects.
Section 3(i): The application was perceived as a method of treatment. The refusal order stated that the used ingredients do not have any percent ratio and it has shown only daily doses form of the ingredients.

For reference the refused claim is as follows: “A composition comprising: i) two units containing 3 mg estradiol valerate, ii) 5 units containing 2 mg estradiol valerate and 2 mg dienogest, iii) 17 units containing 2 mg estradiol valerate and 3 mg dienogest, iv) 2 units containing 1 mg estradiol valerate, and v) 2 units containing placebo.”

In response, Bayer filed an appeal at the Delhi High Court contended that the objection under Section 3(e) was not raised in the hearing notice and was objected by the Controller of Patents only at the time of the scheduled hearing. As the specific ground of refusal was not mentioned in the notice preceding the hearing, the appellant was deprived of a fair opportunity to address the objection and therefore was prevented from preparing a defense against an objection that was never raised before the hearing.

Further, with respect to rejection under Section 3(i), Bayer contended that the same has been critically misinterpreted. The Controller had failed to distinguish between a composition and a method of treatment because the claim, as delineated, underscores that the patent application was directed towards composition rather than a method of treatment.

Issues

Whether the final claims fall within the scope of Section 3(e) & Section 3(i) of the patents Act 1970?
Whether raising new substantial objections directly at the time of hearing not infringes upon the principles of natural justice for Applicant?

Observation and Decision of the Court

First, the Court observed that procedural fairness of hearings has been clearly omitted in this case as the Controller of Patents had not communicated the objection under Section 3(e) beforehand. Citing Perkinelmer Health Sciences INC and Ors v. Controller of Patents, [2] and Dolby International AB v. The Assistant Controller of Patents and Designs [3], the Court noted that the Controller is obliged to enumerate all pending objections in the hearing notice in order to allow the Applicant to adequately prepare and present their arguments concerning the specified objections. A failure to do so is violative of the principles of natural justice that can significantly prejudice the Applicant’s ability to effectively address and counter the objections raised.

Regarding the objection under Section 3(i), the court found that the claim 1 clearly pertains to a product not a method of treatment. The court noted that the claims focused on a pharmaceutical composition comprising specific active ingredients, and that there is no reference to a particular disease/ treatment/ modes/ manner of administration of the composition.

The Court clarified that the boundaries or the legal limits of the patent protection is defined by the claims themselves, not by the working examples or description provided in the specification. Working examples are meant to demonstrate the practical implementations and feasibility of the invention, but do not delimit the patent’s scope.

Based on these observations, the court held the impugned order refusing the patent, as arbitrary and suffering from procedural irregularities, and remanded the application to the Patent Office for further consideration. It directed that Bayer be granted a fresh hearing, with clear delineation of the objections, with a decision to be rendered within three months from the date of the conclusion of the hearing.

Our Analysis

In this decision, the court clarified that the scope of protection rendered by a patent is based on the claims alone and the working examples and description are essential for demonstrating the feasibility and workability of an invention and do not define the patent’s scope.

The court’s reliance on the claims rather than the working examples brings into focus previous precedents where working examples have played a pivotal role in interpreting the scope of a patent. For instance, in F. Hoffmann-La Roche Ltd. v. Cipla Ltd.[4], working examples were scrutinized to understand the practical application and scope of the claims. The court relied on these examples to understand the practical application of the claimed invention, highlighting that the claims must be substantiated by detailed descriptions and practical implementations. Such precedents underscore the dual role of working examples: while they aid in understanding and applying the claims, they cannot override the explicit language of the claims.

This decision of the Delhi High Court aligns with the treatment of working examples in other major jurisdictions. The United States Patent and Trademark Office (USPTO) views working examples as valuable in demonstrating that the invention is operable and meets the requirements of utility, enablement, and written description under 35 U.S.C. § 112. However, the claims themselves define the legal scope of the patent. The working examples can help to support the claims but cannot extend or narrow their scope beyond what is explicitly claimed. The European Patent Office (EPO) requires that the application provides sufficient disclosure to enable a person skilled in the art to carry out the invention. While working examples help meet this requirement, the claims define the scope of protection. The examples serve to illustrate the claims and provide support but do not alter the legal boundaries set by the claims.

There are scenarios where working examples play a critical role, especially in fields like biotechnology and pharmaceuticals, where the practical implementation of an invention can be complex and multifaceted. In such cases, working examples provide invaluable insights into the feasibility and application of the invention. They can help elucidate the claims and offer a deeper understanding of how the invention works in practice. Moreover, in situations where the claims are broad, working examples can provide the necessary support to ensure that the claims are fully enabled and meet the requirements of utility and written description, as seen in the U.S. in Amgen v. Sanofi [5].

However, reliance on claims alone means that applicants must be meticulous in drafting their claims to ensure they are comprehensive and clear. Any ambiguity in the claims can lead to significant issues during enforcement and litigation. Therefore, patent professionals must work closely with inventors to translate technical innovations into clear and enforceable claims, while also providing comprehensive working examples that illustrate the practical application of the invention to satisfy the enablement requirements of each jurisdiction.

Conclusion

The judgment in Bayer Pharm Aktiengesellschaft v. The Controller General of Patents and Designs reinforces that the scope of a patent is defined by its claims and not by its working examples. This decision highlights the fundamental principle that claims are the legal boundaries of patent protection, while working examples serve to illustrate the practical implementation of the invention.