Recently, the Indian Patent Office rejected a patent application by UPL Ltd. for lack of sufficient disclosure mandated under Section 10(4) of the Patents Act. In the context of this order, SpicyIP intern Deepali Vashist discusses the disclosure requirement under the Patents Act and what it means for the larger patent bargain. Deepali is a third-year law student at NLSIU Bangalore. Her passion lies in understanding the intersections of AI regulation and intellectual property rights. Her previous posts can be accessed here.

UPL Ltd. Logo. Image from here

Understanding IPO’s Rejection of UPL’s Patent Application for Mancozeb and Ortho Silicic Acid Combination in Light of the Patent Bargain and Sufficiency of Disclosure

By Deepali Vashist

Thanks to Sandeep Kanak Rathod for mentioning this development on his LinkedIn profile and sharing the copy of the order with us.  

The essence of the patent regime lies in, the ‘patent bargain’ – inventors are granted a monopoly over their invention for a fixed term of 20 years in exchange for a complete disclosure. This disclosure guarantees that at the expiration of the patent, the invention will enter the public domain, facilitating its utilization and technological progress.

 At the heart of this bargain lies Section 10(4) of the Patents Act of 1970 which delineates the parameters of a complete specification. In addition to the essential criteria of novelty, inventive step, and industrial applicability, a patent application must satisfy the enablement and best mode requirements. However, judicial interpretation of this section remains relatively scarce.

Enablement and Best Mode: Cornerstones of Patent Disclosure

The enablement requirement mandates that a patent application must provide sufficient detail to allow a person skilled in the art or relevant field to reproduce the invention without undue experimentation (see here). On a similar but distinct note, the best mode requirement mandates that inventors reveal the most effective conditions or techniques for performing the invention as known at the time of filing. Under Section 10(4), an applicant is supposed to disclose the best method of performing the invention in the complete specification. This prevents inventors from withholding critical information while still benefiting from patent protection. In India, non-disclosure of the best mode may result in revocation under Section 64(1)(h), whereas failure to sufficiently and clearly define a claim of the complete specification can lead to revocation under Section 64(1)(i).

It is in this light that the recent order by the Indian Patent Office (IPO) rejecting UPL’s patent application (pdf) becomes important. It highlights the ‘enablement’ and ‘best mode requirements’. The claimed invention – a combination of Mancozeb and Ortho silicic Acid – was rejected for several reasons. Here’s a closer look at the key issues raised in regard to Section 10(4):

The UPL Order: Reinforcing Disclosure

UPL’s patent application serves as a textbook example of insufficient disclosure. The opponents’ opposition was based on Section 25(1)(g) contending that the complete specification of the applicant does not sufficiently and clearly describe the invention or the method by which it is to be performed. The application hence failed two counts under Section 10(4):

Section 10(4)(a)

The section mandates that the complete specification must fully and particularly describe the invention, its operation or use, and the method by which it is to be performed.

The Controller noted that the combination was a mere admixture with no specific weight ratios or preparation process disclosed in the claims. To establish the invention’s viability, the applicant must have formulated the composition in accordance with the specified weight ratios and subsequently performed field testing to corroborate the outcomes. A person skilled in the art would be unable to reproduce the invention based on the provided specification, as the process details and technical steps are entirely missing. This is a critical deficiency under s. 10(4)(a).

Section 10(4)(b)

The section mandates the disclosure of the best method for performing the invention however, the same was not disclosed, as it fails to provide any details on the preparation process, physical properties, or stability of the composition. Moreover, the specification failed to include any experimental data or working examples that illustrate the preparation and characteristics of the composition in accordance with the claimed weight ratios.

Disclosure Requirement in the Indian Patent Regime

The order, hence, underscores that mere conceptual disclosure is insufficient, the specification must facilitate the practical implementation of the invention without undue experimentation. As previously mentioned, while cases dealing with the importance of sufficient disclosure are rare, Indian courts have consistently upheld the same while providing for flexibility (discussed below).

In AstraZeneca AB & Anr. v. Emcure Pharmaceuticals Ltd. (2020), AstraZeneca filed an infringement suit regarding its medication Ticagrelor. The Delhi High Court highlighted that for a person skilled in the art to perform the invention, the complete specification must provide clear and sufficient information. In F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd (2008)., the Delhi High Court stressed that disclosing the best method of performing the invention is important.  

In Tata Global Beverages Limited v. Hindustan Unilever Limited (2012), the IPAB clarified that at least one clear method of working the invention must be described, allowing a person skilled in the art to perform the innovation; further, Section 10(4) doesn’t require disclosure of every conceivable implementation, merely the best method. This view can further be clarified by reading along with the decision in FDC v. Sanjeev Khandelwal (2007), where the Madras High Court held that while the best method must be submitted, claims need not be representative of the best method.

The UPL order, adding to this list of cases, exemplifies a judicious interpretation of Section 10(4), offering explicit direction for forthcoming patent applications. The patent system’s objective is not solely to reward inventors but to enhance the public domain with comprehensive technical knowledge for further development by others. This is especially pertinent when we recognize its significance for economic development (see here).

This order emphasizes that the necessity and sufficiency of disclosure are as significant as the novelty or inventive aspect of the invention. With the rapid acceleration of technological advancement, upholding stringent standards for patent disclosure is essential for promoting authentic innovation.



Source link

Leave a Comment

Your email address will not be published. Required fields are marked *