G1/23 – EPO Enlarged Appeals Chamber of the EPO “available” (reference T 0438/19)
In what circumstances can prior public use of a product constitute state of the art due to novelty or inventive activity?[s], specifically if the composition or the internal structure of the product can only be analyzed or reproduced with difficulty? The Technical Appeals Chamber in T 0438/19 recently referred the corresponding issues to the Expanded Appeals Chamber. This question becomes relevant where product reengineering can be a burden, such as in the chemical and life sciences industries.
Article 54(2) EPC establishes that “the state of the art shall be considered to include everything that has been made available to the public (…) by use, or in any other way, before the date of filing of the application European patent.
The key word in this provision is “available”, and the key question is therefore an appropriate threshold for something to have been made “available” to the public. This question, which may seem academic, is sometimes difficult to answer in practice.
The underlying case
In the present case, the patent holder claimed a polymer coating composition. The opponent relied on prior public use of a product called ENGAGE 8400. It was not disputed that such a product was “available” per se on the priority date. However, the patent holder argued that the composition of ENGAGE 8400 could not be tested without undue burden and therefore the product would not pass the allowable prior art test (and therefore should be discarded in its entirety).
The legal test as established by G1/92
The question of what is “available” to the public is not actually first raised by the appeals technical board in room 3.3.3 in T0438/19. It has been before the Expanded Board of Appeals for a decision already in G1/92, and has been discussed by the Expanded Board of Appeals in G2/88 and G6/88 (sections 8, 10, respectively) and in many technical board decisions. appeal before and after.
What has to be available?
If there is some consensus among all the decisions (and also among the disputing parties in the case underlying T0438/19), then the availability standard will apply to a technical education.
But it is actually this reference to “teaching” that makes the question of actual availability difficult to answer, if it is a physical product. Unlike a written statement (for example, a patent), a product cannot actively teach anything. There is no explanation, just the product. So, what is their technical teaching? Certainly, and this is again consensus, an analysis is required to identify the technical teaching that comprises a product.
While G1/92 clarified the question of whether there is a motivational requirement for analysis to cause a product to teach its properties and make them available, once it is in the public domain, G1/91 also brought some (more) ambiguity.
The three-step test according to G1/92
G1/92’s main note is sharp and apparently crystal clear, stating that:
“The chemical composition of a product is state of the art when the product itself is publicly available and can be analyzed and reproduced by an expert, regardless of whether or not particular reasons for analyzing the composition can be identified.”
Therefore, there is a three-step availability test.
(to) First, if the product “as such” is available, which essentially corresponds to the “release date” of that product being earlier than the relevant date.
(b) Second, if the expert can analyze the product
(C) Third, whether the subject matter expert can reproduce the product.
While the first step is self-explanatory, the second is perfectly understandable: an analysis must be possible (otherwise there would be no teaching). However, G1/92 also introduces the reproducibility requirement as a third test step. At first sight, this requirement is superfluous, because after analysis the teaching would be revealed and there is no need for reproduction. However, there are many properties and parameters of a product that can be analyzed. Many may have been successfully tested and a specific product teaching has yet to be revealed. Therefore, reproduction is required to ensure that all physical and structural aspects of the product are understood.
The G1/92 headnote does not provide any additional restrictions, in terms of time, effort, etc. It may be necessary to perform such analysis and reproduction. Therefore, if it can somehow be shown that a product could be tested and reproduced on the priority date, it was prior art. However, section 1.4 of the same decision then states that:
“When it is possible for the expert to discover the composition or internal structure of the product and reproduce it without undue burden, both the product and its composition or internal structure will become state-of-the-art technology.”
Therefore, while the headnote did not mention this explicitly, the reasoning for the decision added another requirement, which said that parsing and replay must be possible without undue burden.
In case T0438/19, the patentee, relying on the G1/92 jurisprudence, argued that prior use should be disregarded as product testing was not possible without undue burden. It is probably correct that no actual polymer compositions that fall within the scope of the claims at issue can be easily analyzed and reproduced. The complexity and variability of such polymeric compositions results in a tremendous effort that would be required to analyze all the parameters that may be necessary to allow true reproduction thereof. But is this undue burden what the enlarged joint in G1/92 meant?
Based on this, the technical appeal chamber raised the following set of questions:
Should a product placed on the market before the filing date of a European patent application be excluded from prior art within the meaning of Article 54(2) EPC for the sole reason that its composition or structure could not be analysed? internal? and reproduced without undue burden by the expert before that date?
If the answer to question 1 is no, is the technical information about that product that was made available to the public before the filing date (for example, through the publication of a technical brochure, non-proprietary literature, or patent) is of state-of-the-art within the meaning of Article 54(2) EPC, regardless of whether the composition or internal structure of the product could be analyzed and reproduced without undue burden on the part of the expert before that date?
If the answer to question 1 is yes or the answer to question 2 is no, what criteria should be applied to determine whether or not the composition or internal structure of the product can be analyzed and reproduced without undue burden in the sense of opinion? G1/92? In particular, is the composition and internal structure of the product required to be fully analyzable and identically reproducible?
The second question in particular seems too strict. It takes the “undue burden” requirement to an extreme and questions whether written evidence about a product’s individual characteristics can be considered “enabled” (i.e., actually disclosed), if that product cannot be reverse-engineered from the analysis.
If such a question were answered in the negative, this could translate into general skepticism about written product information as prior art for products that cannot be reverse-engineered by analysis (and there are many, particularly in biotech, pharmaceuticals, and chemistry).
Although the issue at issue in the underlying case is quite specific and technical, the underlying legal issue and, in particular, the implications of the answers to the questions are fundamental.
Considering that the expanded board would answer the first question positively (and particularly without restrictions), this would mean that in many areas of science a large number of “new” inventions would be possible, because the state of the art they would have which it would be possible to fulfill. being tested, you would lose, overnight, substantial amounts of disclosure.