Originally published on IPKat.
What forms part of the “state of the art” is critical to any assessment of novelty and inventive step. In its answer to the referral in G1/23 the Enlarged Board of Appeal has provided clarity on how reproductivity affects prior use disclosures for the purposes of an patentability assessment. The central issue was whether a product’s inherent non-reproducibility should exclude not only the composition of the product, but also the product per se and any associated technical information, from forming part of the state of the art.
Legal background
In Europe, the novelty and inventive step of an invention are assessed in view of the “state of the art”. Article 54(2) EPC states:
“The state of the art shall be held to comprise everything made available to the public by means of a written description, by oral description, by use, or in any other way, before the date of filing of the European patent application.”
In other words, every public disclosure, in any form, is considered part of the state of the art. However, there remains an important nuance to the interpretation of this provision as to what it means for something to have been “made available” to the public. Particularly, if a product cannot be reverse engineered or reproduced without undue burden by a skilled person, how much can it be said that the product has been “made available”? In answer to this, in G 1/92, the EBA introduced an enablement requirement for prior art. According to G 1/92, the composition of a product only forms part of the state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person.
Case background
The EBA referral G1/23 stemmed from appeal proceedings in T 0438/19. In this case, the Opponent, Borealis GmbH, appealed against the Opposition Division’s decision to maintain the Mitsui Chemicals patent EP 2626911. The patent related to a solar cell sealing material and a solar cell module. At opposition, the closest prior art for inventive step was found to be a complex polymer “ENGAGE® 8400” that had been sold before the priority date. The Opposition Division found that the subject-matter of claim 1 involved an inventive step in view of this prior use of ENGAGE® 8400, on the grounds that a skilled person would not have been able to reproduce ENGAGE® 8400 without undue burden. As such, ENGAGE® 8400 did not form part of the state of the art for the purpose of inventive step analysis.
It was undisputed by the parties that the exact method for manufacturing the ENGAGE® 8400 polymer was not in the public domain when the patent was filed. It was also undisputed that reverse engineering and manufacturing ENGAGE® 8400 would not have been straightforward for the skilled person even if they had a sample of the product for analysis. The patentee thus argued that, since ENGAGE® 8400 could not be exactly reproduced, it should not be considered part of the state of the art under Article 54(2) EPC according to G 1/92. Critically, the patentee further argued that all the technical information, measurable features and properties of ENGAGE® 8400 should thereby also be disregarded for prior art purposes.
The Opponent by contrast argued that, whilst a skilled person would not have been able to exactly reproduce ENGAGE® 8400, they would have been able to make a sufficiently similar product if they knew about ENGAGE® 8400. For the Opponent, G 1/92 did not require the skilled person to be enabled to make an exactreproduction of the prior art product in order for the disclosure of the product per se (as opposed to its composition) to be enabling. Furthermore, the Opponent argued, just because ENGAGE® 8400 per se was not reproducible, it did not follow that all the information about ENGAGE® 8400 that a skilled person would be able to glean from its disclosure, did not thereby not form part of the state of the art.
Questions referred to the EBA
The Board of Appeal in the case found that if ENGAGE® 8400 and the technical information about ENGAGE® 8400 was part of the state of the art, it would prejudice inventive step even if the composition of ENGAGE® 8400 was not known. However, for the Board of Appeal, to answer this question, clarity was needed on how to interpret G 1/92. The Board of Appeal thus referred the following questions to the EBA:
Question 1: “Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54 (2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date?”
Question 2: “If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54 (2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date?”
Question 3: “If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92: In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?
The EBA’s decision and reasoning
The EBA agreed with the referring Board of Appeal that clarity on the fundamental point of law concerning the legal boundaries of the state of the art. The EBA noted that the case law on the reproducibility requirement of G 1/92 was not uniform, displaying a “relatively wide spectrum of how the decisions over the years have interpreted the reproducibility requirement”.
In its decision, the EBA went on to answer Question 1 with an unequivocal “No”. For the EBA, a product put on the market before the filing date of a European patent application cannot be excluded from the state of the art solely because its composition or internal structure could not be analysed and reproduced by the skilled person before that date (Headnote I).
Similarly, Question 2 was answered “Yes”. For the EBA, technical information about a product made available to the public before the filing date forms part of the state of the art, irrespective of whether the skilled person could analyse and reproduce the product and its composition or internal structure before that date (Headnote II).
As a result of the answers to Questions 1 and 2, Question 3 was deemed moot
The core of the EBA’s reasoning in this referral rested on the rejection of an interpretation of G1/92 that creates a legal fiction whereby a non-reproducible product simply does not exist for the skilled person. For the EBA, this approach “would lead to absurd results when applied consistently”. The EBA highlighted that interpreting G 1/92 to exclude a product from prior art because it could not be reproduced by a different route, i.e., not by simply obtaining it from the market, was problematic.
The EBA further clarified that the term “reproduced” in G 1/92 should be understood in a broader sense, encompassing the ability of the skilled person to obtain and possess the physical product from the market. The Board of Appeal emphasised that the “state of the art” is primarily about the “information content, the abstract technical teaching, which does not disappear from the public domain as a question of legal principle once the technical teaching becomes part of the state of the art, i.e. enters the public domain” (r. 85). The EBA particularly referenced T 1553/06, in which an internet disclosure available for only a short time was considered prior art, demonstrating that the temporary availability of information does not prevent it from permanently becoming part of the state of the art.
In G1/23, the EBA thus explicitly rejected the notion that the problem of reconstructing a product’s properties is a technical problem for the skilled person that determines its prior art status per se. Instead, this is a “practical legal problem of proof for the lawyer” (r. 84). For the EBA, the success or failure to prove certain properties of a product, including its exact or partial composition, “has no influence on the legal character of the product as belonging to the state of the art as such” (r. 87). This means that the product itself, as made available to the public, forms part of the prior art and its properties can be proven by any means available, such as analysis or documentation. For the EBA, “[i]t is again a different matter how the established, i.e. proven properties of the product may be taken into account, or precisely the insufficient evidence about hypothetical properties might lead to the finding that the product is not relevant as prior art.” (r. 87).
Final thoughts
The decision in G1/23 thus rejects the notion that a product’s non-reproducibility stops it from forming part of the state of the art. This decision therefore aligns the patent law with reality. For us, it always required a certain degree of mental gymnastics to understand scenarios whereby all the information about a product made available to the public had to be excluded from the state of the art solely because the composition of the product was not known.
Whilst the case at issue in G1/23 related to a complex polymer invention, the decision is of course highly relevant to any field of technology involving highly complex subject matter that it is difficult to reproduce, including pharmaceuticals and devices comprising “black-box” software. G1/23 serves once again to illustrate that both the pharmaceutical and biotech landscape demand an adaptable IP strategy that can respond to rapid scientific advances and evolving legal frameworks. At Evolve, we specialise in crafting robust IP strategies for biotech innovations, from novel therapeutic modalities to breakthrough research tools. We understand the unique challenges biotech companies face, including platform protection considerations, competitive landscapes, and investor expectations. Key to this is also ensuring you have the correct policies in place to prevent prior use disclosures and publications scuppering crucial IP, including fit-for-purpose confidentiality agreements.
Cases of prior use are always a reminder that the sooner you think about your IP strategy, the stronger your position will be. Need IP strategy advice? We would love to hear from you. To stay up to date with the latest pharma IP developments, you can also subscribe to our monthly newsletter.
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