欧州では、出願後に進歩性を主張する際に提出する実験データの証拠が受け入れられる基準について、拡大審判に質問が付託されていました。
事前にpreliminary opinionが拡大審判部からは提示されており、その際は、提出された証拠は原則考慮すべきで、進歩性の効果の認定に際してpost-pulished dataを考慮するかは、「当業者がそのデータについて「significant reason to doubt it」を有するかをクライテリアにすることを仄めかしていました。
www.patent-topics-explorer.com
さて、最終的な決定はどうなったのでしょうか。
まず、事前のpreliminary opinionと同様に、提出された証拠は原則として考慮されるべきというスタンスが提示されています。
1. Evidence submitted by a patent applicant or proprietor to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter may not be disregarded solely on the ground that such evidence, on which the effect rests, had not been public before the filing date of the patent in suit and was filed after that date.
EPO - Press Communiqué of 23 March 2023 on decision G 2/21 of the Enlarged Board of Appeal
そのうえで、「①出願時の技術常識を有する当業者が、②出願時の明細書等に基づき、③技術的教示に包含され、同じ当初開示された発明によって具体化されるものとしててその効果を導き出す場合」、post pulished dataが考慮されるという判断のようです。
2. A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.
EPO - Press Communiqué of 23 March 2023 on decision G 2/21 of the Enlarged Board of Appeal
注目すべきは、決定の中で「plausiblility」という言葉が一切使われていないことです。
これについては、拡大審判部は、「plausibility」は、下記のようにEPCの下で特徴的な法的概念や特定の特許法の要件に相当するものではないと考えたことが理由のようです。
The Enlarged Board further considered that the term "plausibility" did not amount to a distinctive legal concept or a specific patent law requirement under the EPC.
EPO - Press Communiqué of 23 March 2023 on decision G 2/21 of the Enlarged Board of Appeal
正直、結局どう判断したらいいのという感じですが、拡大審判部もあいまいであることは承知しているようです。
(ref 95) The Enlarged Board is aware of the abstractness of some of the aforementioned criteria.
G2_21_Decision_ of_the_Enlarged_Board_of_Appeal_of_23_March_2023_EN.pdf (epo.org)
審判部等の判断が割れていますが、plausiblityを使わずとも今回の拡大審判部の基準を使えば、それぞれのケースは説明できるという立場のように思えます。
(ref 77) Applying this understanding to the aforementioned decisions, not in reviewing them but in an attempt to test the Enlarged Board’s understanding, the Enlarged Board is satisfied that the outcome in each particular case would not have been different from the actual finding of the respective board of appeal. Irrespective of the use of the terminological notion of plausibility, the cited decisions appear to show that the particular board of appeal focussed on the question whether or not the technical effect relied upon by the patent applicant or proprietor was derivable for the person skilled in the art from the technical teaching of the application documents.
G2_21_Decision_ of_the_Enlarged_Board_of_Appeal_of_23_March_2023_EN.pdf (epo.org)
こちらにもあるように、技術分野の影響もあるという考えのようなので、結局はケースバイケースということになりそうです。
(ref 95)However, apart from the fact that the Enlarged Board, in its function assigned to it under Article 112(1) EPC, is not called to decide on a specific case, it is the pertinent circumstances of each case which provide the basis on which a board of appeal or other deciding body is required to judge, and the actual outcome may well to some extent be influenced by the technical field of the claimed invention. Irrespective of the actual circumstances of a particular case, the guiding principles set out above should allow the competent board of appeal or other deciding body to take a decision on whether or not post-published evidence may or may not be relied upon in support of an asserted technical effect when assessing whether or not the claimed subject-matter involves an inventive step.
G2_21_Decision_ of_the_Enlarged_Board_of_Appeal_of_23_March_2023_EN.pdf (epo.org)
面白いところとしては、進歩性のpost-pulished dataと、記載不十分のpost-published dataの基準の違いにつもて付言されており、記載不十分のpost-published dataが参酌される基準の方が、ハードルた高いと明言されています。
(ref 72) The reasoned findings of the boards of appeal in the decisions referred to above make clear that the scope of reliance on post published evidence is much narrower under sufficiency of disclosure (Article 83 EPC) compared to the situation under inventive step (Article 56 EPC). In order tomeet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post-published evidence.
G2_21_Decision_ of_the_Enlarged_Board_of_Appeal_of_23_March_2023_EN.pdf (epo.org)
結局すっきりとした回答は拡大審判部からはなく、今後も技術分野によってpost-published dataが受け入れらるかの甘辛判定などが異なったり、明細書でどのような記載をしておくとよいか継続的に検討していく必要がありそうですね。
