Future Decision G 1/23 Will Complement Opinion G 1/92 By Attempting to Clarify The Threshold Of Enablement For Complex Products To Form Part Of The State Of The Art
Future decision G 1/23 of the Enlarged Board of Appeal of the European Patent Office will shed the light on the criteria that must be met for a (complex) product subject to prior use to form part of the state of the art, and in particular on the extent to which the composition or internal structure of the complex product should be analyzable and reproducible by a skilled person. Decision G 1/23 will therefore complement established opinion G 1/92, the interpretation of which has nonetheless been the source of divergent case law for 30 years. Importantly, an answer may be brought as to whether a prior used, not enabling and/or partially disclosed complex product excludes only the features of the product which cannot be analyzed and reproduced by the skilled person without undue burden, only exclude the whole composition (or internal structure) of the product, or exclude both the composition (or internal structure) and the product itself from the state of the art.
The first referral of 2023 to the Enlarged Board of Appeal arises from an appeal (T 0438/19) seeking to overturn a decision to reject an opposition filed against patent EP 2626911 B1, claim 1 of which being directed to a material suitable as an encapsulating material for solar cell, comprising an ethylene/alpha-olefin copolymer having a specific composition (content of structural units deriving from ethylene and alpha-olefin, content of aluminum) and properties (MFR, density, Shore A hardness). During the proceedings of T 0438/19, the parties shared conflicting views on whether ENGAGE® 8400 – an ethylene/1-octene copolymer commercially available before the effective filing date and fulfilling all the claimed properties except for the content of aluminum – could represent, in light of opinion G 1/92, the closest prior art for assessing inventive step under Article 56 EPC. The dispute extended to prior art documents that the Board also had to consider, which mentioned ENGAGE® 8400 and disclosed some properties thereof, demonstrating that ENGAGE® 8400 fulfilled all the requirements of claim 1 except for the content of aluminum, while remaining silent on its synthesis and failing to fully disclose all details about its composition and internal structure.
Article 54(1)(2) EPC sets out that “An invention shall be considered to be new if it does not form part of the state of the art”; and that “[t]he state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application”. Opinion G 1/92 concerns the interpretation of the requirement “made available to the public” referred to in Article 54(2) EPC in relation to the prior use of a product.
According to the conclusion and headnote of opinion G 1/92, the “chemical composition of a product forms part of the state of the art when the product as such is available to the public and can be analyzed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analyzing the composition” and “[t]he “same principle applies mutatis mutandis to any other product”. The opinion has been consistently applied in the case law with respect to the settled issues, i.e., whether the skilled person had reason to analyze the composition, and whether the opinion applies only to chemical products, the answer being clearly “no” to both questions.
The present referral relates instead to the enablement of a (complex) product already available to the public, and in particular to whether its composition or internal structure should be analyzable and reproducible without undue burden for the product to form part of the state of the art. As a polyolefin, ENGAGE® 8400 exhibits a complex 3D molecular structure, consisting of a mixture of heterogeneous, entangled polymeric chains having a specific molar mass, comonomer incorporation ratio, branching and stereoregularity. Polyolefins are usually defined in terms of various properties and statistical parameters at a macroscopic level which relate to their structure. In the case at issue T 0438/19, it was argued that reverse-engineering of a commercial polymer without knowledge of its synthesis conditions (e.g., the specific catalysts and reaction conditions) requires an extensive research program and constitutes an undue burden for the skilled person. The focus was therefore set on paragraph 1.4 of the reasons of opinion G 1/92, in which the Enlarged Board reasoned that “[a]n 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”.
The Board noted that diverging approaches have been adopted in applying opinion G 1/92 for the past 30 years, leading in turn to legal uncertainty when it comes to assessing what forms the state of the art in relation to a commercially available product. In particular, divergent decisions were identified with regard to the following three aspects: i) the interpretation of "available to the public" leading to the exclusion from the state of the art within the meaning of Article 54(2) EPC of the product itself (including its chemical composition/internal structure) or only of its chemical composition/internal structure; ii) the degree of detail required for the analysis of said product; and iii) the requirements for its reproducibility.
With respect to aspect (i), the Board insisted on the fact that the difference between excluding the product or only its composition/internal structure from the state of the art was not only of theoretical interest. The Board pointed out that if it is decided that only the composition is excluded from the state of the art, in the present appeal, the product itself – still forming part of the state of the art – could definitely be used as a starting point for the assessment of inventive step, considering that the partial technical information about ENGAGE® 8400 reported in documents of the state of the art (e.g., leaflets for the sold product) included its potential uses and advantages, making it of particular interest for the skilled person.
With respect to aspects (ii) and (iii), the Board considered how strictly the requirement to analyze and reproduce the alleged prior art product should be interpreted, wondering for example whether conditions (ii) and (iii) implied the full analysis of all features and the reproduction of an identical copy. The Board noted the difficulty in finding a generally recognized definition in the art of what would constitute a comprehensive analysis of a complex product, namely the above-mentioned copolymer in the present case. The Board further noted that in the absence of such a definition, assessing whether a commercial product has been reproduced would necessitate first a definition of that product which would appear to be dependent on deliberate choices concerning the aspects of the composition or structure to be analyzed and the level of identity required, thereby introducing subjectivity in the assessment of novelty, and in turn, legal uncertainty.
As an additional consideration, the Patentee/Respondent had argued that in a situation of a commercial product whose production would require know-how willingly kept secret resulting in said product not being enabled without that information, considering in this case said product to be comprised in the state of the art would result in an inventor to be deprived of their just reward for their contribution to the art, which resides in disclosing to the public how the commercial product can actually be prepared. To counter this position and illustrate the case at hand, the Opponent/Appellant referred to the recipe for Coca Cola, known to be secret, and asked, in the hypothetical situation of a claim merely defining a caramel color containing fizzy drink, how would Coca Cola not be seen to anticipate such subject-matter.
The following questions were referred to the Enlarged Board of Appeal for decision:
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 analyzed 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 analyzed 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 analyzed 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 analyzable and identically reproducible?
Excluding a complex product from the state of the art for the sole reason that it was in part difficult to analyze or reproduce would result in a major shift in practice. The future decision G 1/23 is therefore expected to provide clarity on the enablement criteria that must be met for a complex product to form part of the state of the art. This happens in a context where important decisions related to enablement have recently been released, such as G 2/21 (reliance on a purported technical effect for inventive step - plausibility) or T 43/18 (confirming that a higher level of purity may be novel, shifting the patentability hurdle from novelty to inventive step). While the referring case is concerned with chemical subject-matter, the outcome of G 1/23 will undoubtedly have implications in all technical areas involving complex products, be they, to cite only a few, chemical compounds and compositions, antibodies, mechanical and electrical devices or systems made of multiple components.
