One of the cornerstones of the European Patent Convention (EPC) is Article 54, which provides the legal basis for assessing the novelty of an invention. An invention is considered novel if it does not form part of the state of the art within the meaning of Art. 54(2) EPC:

“The 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.”

The EPC does not make any distinction regarding how information is made available to the public. Therefore, information derived from the use of a product made available to the public is subject to the same conditions as information derived from oral or written disclosures. This raises the following questions:

(1) to what extent does information, e.g., internal composition or intrinsic properties, derived by virtue of the use of a product constitute state of the art?

(2) how does this information affect the public availability of the product per se, i.e., is the product excluded from the state of the art if such information cannot be directly derived from it?

The “enablement requirement” according to G1/92

G1/92 previously provided the answers to the above questions by introducing the “enablement requirement”, also referred to as the “reproducibility requirement” for products made available to the public by virtue of their use.

Reason 1.4 of G1/92 states:

“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.”

Notably, G1/92 was concerned with the legal question of whether the skilled person needed any motivation to analyze the composition or internal structure of a given product for the composition to be made available to the public, which was answered in the negative.

However, G1/92 has since been interpreted in case law as putting forth an additional requirement, the so-called enablement requirement that a product put on the market needs to be reproducible for it to be considered as part of the state of the art.

The interpretation of G1/92 was the major point of dispute in the referring decision leading to G1/23. In the appeal proceedings of T0438/19, the Opponent, i.e., the Appellant (Borealis GmbH) contested the fact that the commercially available product, the polymer ENGAGE® 8400, was to be excluded from the state of the art solely for the reason that its composition could not be reproduced by the skilled person, owing to its complexity. Referring to G1/92, the Patent Proprietor (Mitsui Chemicals, Inc.)  argued that ENGAGE® 8400 needed to fulfill the condition of reproducibility for it to be considered as part of the state of the art within the meaning of Art. 54(2) EPC.

Having regard to the above, the Technical Board of Appeal referred the following questions of law to the Enlarged Board of Appeal (EBoA), prompting for the correct interpretation or a “reinterpretation” of the enablement requirement set forth by G1/92:

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 its internal structure could not be analyzed 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 analyzed 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 analyzed and reproduced without undue burden within the meaning of opinion G1/92? In particular, is it required that the composition and internal structure of the product be analyzable and identically reproducible?

Interpretation of G1/92 according to the EBoA

With respect to G1/92, the EBoA finds that two interpretations are at least grammatically possible in view of Reason 1.4. As underlined above (see reason 1.4 of G1/92), the ‘it’ as used in the wording of G1/92 may refer to either the composition or the internal structure of the product per se or the product as such. According to the EBoA, this leads to two different interpretations:

Interpretation 1:

Where the composition is non-reproducible, then both the product and its composition do not form part of the state of the art.

Interpretation 2:

Where the composition is non-reproducible, then the product as such forms part of the state of the art but the composition per se does not.

Arguably however, for the skilled person, the problem of reproducing a product may be perceived as equivalent to the problem of reproducing its composition.

According to the EBoA, if the first interpretation holds true, this would lead to a case of legal fiction wherein the commercially available product legally does not exist for the skilled person. The EBoA finds that this interpretation would contradict everyday experience and would lead to absurd results if consistently applied. In order to prove their point, the EBoA presented the extreme example of the skilled person having to solely rely on reproducible starting materials to prepare a product. Considering that according to the first interpretation, non-reproducible materials do not exist to the skilled person, the skilled person has no choice but to turn to solely reproducible starting materials. Assuming that such materials do not exist, then the skilled person is again faced with the problem of preparing the starting materials using reproducible precursor materials. If both precursor materials and starting materials are not available, the skilled person is inevitably caught in a never-ending cycle of finding the appropriate reproducible starting materials to solve the technical problem of preparing the product. With this example, the EBoA demonstrates that the first interpretation if consistently applied leads to the absurd result that no starting material in the physical world would belong to the state of the art.

The second interpretation leads to the understanding that the skilled person knows that the product has a composition but deliberately chooses to ignore it solely because the composition is non-reproducible. In the Board’s opinion, this interpretation is also not in line with everyday experience. The EBoA argues that materials or products are chosen as solutions by the skilled person owing to their properties which are determined by their compositions. Therefore, the skilled person cannot simply ignore the composition of a material or product because it is non-reproducible. On the contrary, the skilled person, assuming a promising starting point, will choose a certain material or product as a plausible technical solution by virtue of its composition even though the skilled person may not be able to reproduce said composition.

In light of the above, the EBoA sets forth the correct interpretation of G1/92:

“The chemical composition of a product is part of the state of the art when the product as such is available to the public and can be analyzed by the skilled person, irrespective of whether or not particular reasons can be identified for analyzing the composition.”

Of note, the above interpretation is applicable to the internal structure or composition of all products, chemical or non-chemical, man-made products or products derived from nature.

This interpretation effectively removes “the reproducibility requirement” for a product to form part of the state of the art. This implies that a product constitutes prior art even though its composition cannot be reproduced.

In light of this interpretation, question 1 was answered with a “no” and question 2 with a “yes”. Since the product forms part of the state of the art, it follows that technical information relating to the product also forms part of the state of the art. In view of the answers to questions 1 and 2, question 3 was rendered moot.

The EBoA has omitted the requirement of the “undue burden” (see reason 1.4 of G1/92 above) in their answers. For the EBoA, it was not apparent that the properties of ENGAGE® 8400 considered by the Technical Board of Appeal were obtainable solely by an analysis which would require efforts beyond undue burden. The EBoA however emphasizes that the fact that they did not address the requirement of the “undue burden” does not mean that the issue of the “analysis without undue burden” can never arise.

Is the duration of market availability relevant to the prior art status of the product?

The short answer is no. The patent proprietor argued that man-made products cannot be considered to be “available to the public” because they may disappear from the market or may change. The EBoA finds that this is rather the problem of the attorney as it concerns the reconstitution of the properties of the product to determine what has been disclosed by it at the time of filing of an EP application. This is a question of legal certainty and is not equivalent to the problem of the skilled person to reproduce the product. The EBoA concludes that a product may disappear from the market or evolve, as a natural course, however, the abstract teaching derived from it will always remain a part of the state of the art.

Key Takeaways and Implications

The decision of the EBoA aligns case law with the reality of the skilled person. The technical teaching derived from a product should now be understood in the broader sense and not limited to the technical teaching related to the preparation of the product. According to the EBoA, the concept of reproducibility of the product should also be understood more broadly, also encompassing the possibility that the skilled person can just acquire the product in its readily available form on the market. Thus, the patent attorney cannot rely on the “reproducibility requirement” to exclude commercially available products from the state of the art.

That the decision also encompasses products derived from nature is not surprising. A product occurring in nature as such is not patentable as it is considered a mere discovery under Art. 52(2)(a). However, if isolated and if a technical effect can be derived from the isolated product, then it may constitute a patentable invention.

The outcome of G1/23 has the following implications:

• For the patent attorney or consultant faced with the task of assessing the patentability of an invention, the boundaries of the state of the art within the meaning of Art. 54(2) have just been “broadened” in view of the decision. Products put on the market by fellow competitors, even if not reproducible, have become viable starting points to assess the state of the art in the field of the invention. This may prove to be a complicated task, especially in the situation where all of what is known of a commercially available product is solely its trademarked name.
• For the inventors or companies considering placing their product on the market, the decision highlights how important it is to coordinate commercial activities with the filing of patent applications. This is always of high relevance in order to prevent one’s own product becoming prior art detrimental to the patentability of one’s own invention. Thus, involving a patent attorney or consultant in the planning of commercial activities might be of strategic importance. This ensures that all measures have been taken to secure all potential patentable aspects of the product before its launch.
• For the inhouse patent attorneys or consultants, close collaboration with other departments is required to align IP strategy with commercial activities. This may involve:

1. aligning with the commercial team to ensure the timely filing of patent applications on all aspects of the product before it is placed on the market,
2. carefully reviewing any documentation from the marketing and technical teams, e.g., marketing or technical brochures or scientific presentations or articles to ensure that technical information on the product are not disclosed to the public before the filing of a patent application,
3. keeping up to date with the technical team and inventors on product developments to ensure that new patent applications on these developments are timely filed,
4. establishing non-disclosure agreements (NDA), e.g., when showcasing the product or offering samples of the product to collaborating partners.

• For third parties, it is in their interest to monitor the commercial activities of their competitors to determine if they are aligning product launches with corresponding patent filings.

Finally, while the EBoA’s decision provides certainty on the ‘prior art’ status of a commercially available product, it does not provide definitive answers or guidance on what constitutes “analysis beyond undue burden”. This could mean that a property or a feature of a commercially available product which cannot be analysed without undue burden may not constitute prior art. It will be interesting to see how future case law will interpret the “analysis without undue burden” requirement, which was not addressed by the EBoA in G1/23.