23 April 2024

Will G1/23 introduce an “on-sale bar” at the EPO?

Recent Enlarged Board of Appeal referral, G1/23, seeks to obtain clarity on when a product, or published technical information relating to such a product, can be considered to be state of the art, depending on the degree to which the composition and internal structure of the product may be analysed and reproduced. However, one potential consequence of a Decision on the referral could be to introduce an “on-sale bar” type exclusion from patentability, as applied by the United States Patent and Trademark Office (USPTO). This could, for example, apply to patent applications directed to commercial products historically covered by trade secrets, where reverse engineering the exact products would be expected to be extremely difficult.

Background of the case

The case giving rise to the referral to the Enlarged Board of Appeal – T483/19 – was an appeal against a Decision of the Opposition Division rejecting an opposition filed against European Patent No. 2 626 911. The patent was directed to a material suitable as an encapsulating material for a solar cell, the material comprising an ethylene/alpha-olefin copolymer and defined by a number of parameters, including melt flow rate, density and shore hardness.

In this case, novelty of the claimed material was not at issue but rather it was the availability to the public of a commercial product – ENGAGE® 8400 – named in an example of a prior art document, which was considered to be of critical importance in determining the closest prior art for the purposes of assessing inventive step. For context, ENGAGE® 8400 was commercially available and prior art data sheets show the product to have all of the properties of Claim 1, except for aluminium content. What wasn’tin the public domain was how to make ENGAGE® 8400.

The Patentee argued that, in order for the commercial product to be considered state of the art, the skilled person must be able to produce a polymer that is exactly (and not just similar to) ENGAGE® 8400 and do so without undue burden. This, the Patentee argued, was in line with established jurisprudence following the Enlarged Board of Appeal Decision in G1/92.

According to the headnote for Decision G1/92, the “chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition” and the “same principle applies mutatis mutandis to any other product”.

In the reasons for the Decision, the Enlarged Board in G1/92 stated that an: “essential purpose of any technical teaching is to enable the person skilled in the art to manufacture or use a given product by applying such teaching. Where such teaching results from a product put on the market, the person skilled in the art will have to rely on his general technical knowledge to gather all information enabling him to prepare the said product. Where it is possible for the skilled person to discover the composition or the internal structure of the product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art“.[Emphasis added] – paragraph 1.4 of the Reasons.

The Opponent in T483/19 sought to cast doubt on the reproducibility criterion in the reasons of G1/92, pointing to an alleged inconsistency between the reasons and the headnote to the Decision. The Opponent also pointed to other Decisions of the Enlarged Board (including G2/88) which might be seen to suggest that the intention was for availability to the public (so as to be considered state of the art) to be determined by accessibility of the public to the prior art product, rather than depending on whether the accessible product could be reproduced without undue burden.

On the other hand, the Patentee identified Decisions applying G1/92 and establishing three criteria for a product to be considered available to the public so as to be state of the art: 1) a member of the public is able to access the product; 2) a skilled person must be able to analyse the composition or internal structure (i.e. must be able to access the information that is inherent to the product); and 3) a skilled person must be able to reproduce the product based on common knowledge and without undue burden, as only then, it was argued, does it represent a complete technical teaching.

The submissions of both parties established an apparent divergence in the application of G1/92 which was considered justification for the referral to the Enlarged Board of Appeal for guidance.

G1/23 – The referral

The Technical Board in T483/19 referred the following questions to the Enlarged Board of Appeal:

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?

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?

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?

Thus, the referral seeks to establish the extent to which the reproducibility criterion is critical for a product to be considered state of the art and whether published technical information relating to the product can be considered state of the art, regardless of whether the composition or internal structure of the product can be analysed and reproduced without undue burden.

Clearly, the referral in G1/23 is focused on commercial products having compositions and internal structures that are not readily reverse engineered. Nevertheless, the potential reach of a Decision on the referral is significant and not only limited to polymer technologies, nor indeed only chemical inventions.

USPTO on-sale bar

Many readers will be familiar with the USPTO’s “on-sale bar” provision – a statutory bar found in Section 102 of the United States Patent Act – which excludes from patentability products or processes which have been on-sale before the “critical date”, 12 months prior to the filing of the US patent application.

The on-sale bar under the America Invents Act (AIA) even extends to confidential sales, as confirmed by the U.S. Supreme Court in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. In that Decision, it was concluded that the AIA did not narrow the scope of the on-sale bar in patent cases, and that the term “on sale” had a well-settled judicial interpretation that included confidential sales, prior to the enactment of the AIA. More recently, in an appeal to the Federal Circuit – In re Certain High-Potency Sweeteners (Inv. No. 337-TA-1264) – it has also been held that a confidential process could give rise to an on-sale bar. Thus, even confidential sales of an invention deriving from the inventor more than 12 months prior to the filing of the US application are prejudicial to the subsequent patent filing.

Potential consequences of G1/23

One might question whether it is legitimate for an innovator company who has sold a product covered by a trade secret – where the composition and internal structure of the product are not specifically disclosed and cannot be identically reverse engineered – to later apply for patent protection for the same product. A clear benefit to the public of said company pursuing patent protection is the full knowledge of the composition and internal structure of the product and an understanding of how the product is reproduced, which information would be expected to be contained in a (sufficiently enabled) patent application. In general, there is a tranche of European Patent Office (EPO) case law following G1/92 which would appear to give the green light to such a practice. However, there is the potential for the Decision in the new G1/23 referral to disrupt this notion.

Although in the referring case, T483/19, it is only inventive step which is at issue, it seems clear that the referral in G1/23 is not limited to that particular context and a Decision could equally be relevant to the consideration of novelty. This is of course particularly the case if it is decided that the reproducibility criterion is not an essential requirement in order for the commercial product to be considered state of the art (question 1 of the referral), even if its composition and internal structure is not state of the art.    

If it is decided that technical information about a commercial product can be state of the art, even when the product itself may not be analysed or reproduced, then this potentially opens the door for publicly available disclosures of such information (which pre-date the patent filing) to be taken into account from either a novelty or inventive step perspective. This is of particular relevance when considering the closest prior art and technical effects underpinning a claimed invention which form part of the EPO’s problem-solution assessment of inventive step (as we have seen in the referring case, T483/19). It is also likely to be of greater significance when claims are defined by reference to performance parameters, as opposed to purely compositional and structural features.   

In these scenarios, the result could be a shift closer to something resembling an on-sale bar, despite the fact that the commercial product could not be analysed and reproduced prior to the filing of the patent application.

Another interesting element to the referral is the notion that there could be a distinction over when a product may be considered available to the public based on the degree to which its composition and internal structure may be analysed and reproduced. Should it be necessary for its composition and internal structure to be fully analysable and identically reproduced without undue burden (question 3 of the referral) in order for the commercial product to be considered state of the art? If not, where should the line be drawn?

What if, for instance, the commercial product may be analysed and reproduced to a degree that yields a closely related (but not identical) product which shares the same or very similar performance characteristics reported in technical information for the commercial product? Would that then mean that the commercial product itself forms part of the state of the art? If that was the case, then there would again be a shift more towards something resembling an on-sale bar than currently exists at the EPO.

With increasing advances in analytical chemistry (particularly with the potential contributions of AI in the future) understanding what might constitute an “undue burden” for the skilled person to analyse and reproduce the product is clearly a concept that should evolve with the advances in the technology at the disposal of the skilled person. Thus, it also seems possible that what might constitute an undue burden now, may not be considered so in the future.

Impact on IP / commercialisation strategy

If as a consequence of the Decision in G1/23 there is the perception of at least some movement toward an on-sale bar type exclusion before the EPO, then there may be incentive for applicants to consider filing patent applications earlier, or at least before commercialising the products of their innovations. Alternatively, it may prompt a more considered approach as far as product marketing is concerned, and particularly in terms of the content of technical brochures etc., for those innovators who might still wish to seek patent protection after an initial commercial sale of a product covered by a trade secret.

If there is the potential for technical information to be considered state of the art, even where the commercial product to which it relates is not (fully) analysable or (identically) reproducible without undue burden, it may prompt applicants to consider how claims to such products are defined in later filed patent applications. For instance, there may be a preference to avoid defining such products by reference to parameters, if those same parameters are disclosed in technical brochures associated with the commercial product. This may prompt applicants to consider defining products by features of their chemical composition instead, where possible, or possibly even by features of a process used to prepare them.

Alternatively, it may encourage innovators to take additional steps to preserve their trade secrets in preference to pursuing patent protection, albeit at the risk that third parties could independently develop the same technology at some point in the future.  

Watch this space…

A Decision in G1/23 brings with it the possibility of somewhat of a sea change in the way the EPO assesses disclosures of products having compositions and internal structures of varying degrees of analysability and reproducibility. Depending on where the line is drawn in considering whether those products, or published technical information relating to those products, may be considered state of the art, it seems that there is the real possibility for the EPO to inch closer to an on-sale bar type exclusion. This could have an impact on the IP and commercialisation strategies of innovators in numerous technology fields.