A development that patent lawyers are surely going to find interesting, on March 13, the Delhi High Court, in Bayer Pharm Aktiengesellschaft v. The Controller General of Patents & Designs, clarified that a working example does not define the patent’s scope. Raising some concerns with this finding of the Court, we are pleased to bring to you this guest post by Dhruv Vatsyayan. Dhruv is a final year B.A. LL.B. (Hons.) student at the Faculty of Law, Banaras Hindu University, Varanasi with interests in IP and Constitutional Law.
Leaving Out the Working Examples?
By Dhruv Vatsyayan
The IPD of Delhi High Court, on March 13, 2024 in Bayer Pharm Aktiengesellschaft v. The Controller General of Patents & Designs observed that though “working examples are essential for demonstrating the feasibility and workability of an invention, they do not define the patent’s scope.” To put this in simpler words, what this judgement intends to put forth is that a working example does not play any role in the patent claim construction. This stance resonates with the long running jurisprudence (see, para 35-37) that claim construction must be done objectively and as far as possible on its own terms, without referring to any extrinsic material.
In this post I would like to flag some issues with this approach.
What are Working Examples?
The term ‘Working Example’ as such is neither used nor defined anywhere in the Patent Act, 1970, Patent Rules, 2003 or, the Manual of Patent Office Practice & Procedure, 2019. Nonetheless, it can be defined as something which relates to work that has already been performed. To be specific, “working examples often describe experiments that have previously been conducted, as well as results actually obtained from those experiments.” These are just like other theoretical or prophetic examples, but based on prior experiments and empirical data. In some applications, these are also mentioned as ‘use examples’.
More often than not, you can find such examples (See, 5818/DELNP/2006 (Page 7-9), 1607/DEL/2010 (Page 8-12) and, 3400/DELNP/2004 (Page 3-8)) in the patent applications related to biological, chemical or pharmaceutical fields. Paragraph 05.03.09 of the Manual of Patent Office Practice & Procedure, 2019 lays down that “a detailed description of an invention, which forms the part of the complete specification, may include examples/drawings or both for clearly describing and ascertaining the nature of invention. Examples must be included in the description, especially in the case of chemical related inventions.” Therefore, examples, whether prophetic or working, form the part of the description and the complete specification.
According to paragraph 05.03.01 (see, point g) of the manual, a complete specification shall not include irrelevant or other matter which is not necessary for elucidation of the invention. This in present context means that although providing ‘working examples’ is not mandatory on part of the patent applicant, if it is provided in the complete specification, it is relevant while defining the invention and scope of the same. This by implication is the extension of section 10(4)(a) of the Patents Act, 1970, which mandates that complete specification shall fully and particularly describe the invention. A reasonable sequitur from the above is that a working example, wherever appended and, especially in inventions related to bio-chemical and pharma related industry, is something which is necessary for elucidation and understanding of the concerned invention.
Some Red Flags
Since it has been established above that working examples are part of the complete specification, I would proceed to show how these can be relevant while constructing the claims. To prove this, I would put forth two arguments; firstly, there is some degree of relation between claims and complete specification (which at times may include ‘working examples’) vis-à-vis disclosures. Secondly, to solely rely upon the claims literally, and not considering materials like working examples, would make it difficult for the examiner to examine the patentability of the invention qua non-literal infringement.
In Novartis AG v. Union of India, the Supreme Court observed that the coverage/claims of the patent cannot go much beyond the disclosure made in the patent application. To say otherwise would negate the fundamental rule underlying the grant of patent. (see, para 139) In this context, Sections 10(4), 25(1)(g) and 64(1)(h) of the Patents Act, 1970 are very significant.. Section 10(4) necessitates full and complete disclosure of the method and description of the invention, inter alia. On the other hand, Sections 25(1)(g) & 64(1)(h) of the 1970 Act mandates that the failure to describe the invention or the method by which it is to be performed sufficiently and clearly can be a ground for opposition and revocation. A conjoint reading of all these provisions warrants that at times, such sufficient and complete disclosure may also include ‘working examples’. In such situations, ‘working examples’ being a part of the disclosures may also act as a restraint on the coverage/claims of the patent. For this reason, the working example, which forms a part of disclosures contained in the complete specification must not be ignored while constructing the claims.
This becomes more important when the examiner is employing the test for non-literal infringement. It is so because before issues such as infringement or validity are discussed, the scope of the claims must be clearly construed so that it is uniformly applied to either infringement or validity. A case for non-literal infringement is made out where each and every component of the patent specification is not found in the infringing products. In other words, in non-literal infringement the defendant’s invention falls outside the literal scope of the patent claims. Hence, in such situations, the patent claims are to be construed purposively and not just literally. This is where a working example comes into play. They provide support and understanding for the claimed invention. Moreover, since working examples are intended to show that the invention is feasible and workable and how it can be carried out in practice, they facilitate a better understanding of the non-literal import of the patent claims. (see, para 9)
To approach working examples otherwise would have very significant ramifications on the best method requirement and disclosures. There may arise a situation where disclosures are made in complete specification by way of providing working examples and without taking into account the same, examiner may come to a conclusion that claims go beyond what is disclosed in complete specification. Moreover, especially in cases of non-literal infringement, such a narrow view impairs the ability of the examiner to construct the claims in a holistic manner. Therefore, this quandary needs to be resolved by the courts in the near future.
