EP 3 400 943 B1 results from a divisional application of EP 2 827 900 published as WO 2013/142875, and relates to an amorphous solid dispersion for use in the treatment of local or metastatic brain cancer that is caused by ErbB2 over-expression or amplification.
Brief outline of the case
Both oppositions were rejected and both opponents appealed.
Tthe OD decided that the priority was not valid because the feature of the compound being in amorphous form was not disclosed in the priority document.
The board endorsed this conclusion as it has not been contested in appeal by the proprietor.
The board decided revocation for lack of IS of claim 1 as granted over D3+D9.
The relevant documents
D3=Cancer Research (April 2012), Volume 72, Issue 8, Supplement, Abstract 852 was thus prior art under Art 54(2).
D9=Poster: “Amorphous dispersion development of ARRY-380, an ErbB2 selective inhibitor”, Lindemann et al.
D9=Poster: “Amorphous dispersion development of ARRY-380, an ErbB2 selective inhibitor”, Lindemann et al.D9a: web.archive.org/web/20150827010938/http://arraybiopharma.com/publications/?ccm_paging_p_b971=7 (Printout Wayback-Machine, 27 August 2015)
The case is interesting as it had to be decided whether the poster D9 was prior art under Art 54(2).
The OD decided that D9, which related to a poster presentation, did not represent prior art, because it could not be established that the content of the poster of document D9 had become available to the public before the filing date for the patent.
The board came to a different conclusion.
The opponents’ point of view
The opponents have argued that the link presented in document D9a lead directly to D9. This has not been contested by the patent proprietor.
The opponents have further argued that document D9, as well as document D9a, originate from the proprietor, which has also not been contested by the patent proprietor.
D9a does not merely refer to a presentation for a conference on 17.10.2012 under the same title and from the same first author as D9, but actually indicates by the presented link to document D9 that this presentation indeed concerned the poster of D9.
Moreover, by listing this presentation, D9a further indicates that the poster of D9 was indeed presented to the public at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists on 17.10.2012.
The proprietor’s point of view
The proprietor argued that D9a does not provide the required evidence as to the actual content of the presentation at the conference or even whether the presentation took actually place at the conference in 2012. In its view the standard of proof beyond reasonable doubt applied in this regard and what was actually presented at the conference could in its view only be proven on the basis of witness testimony.
The board’s decision
According to the established jurisprudence the proceedings before the EPO are conducted in accordance with the principle of the free evaluation of evidence.
In accordance with this principle, the deciding instance takes its decision on the basis of all the evidence available in the proceeding in the light of its conviction arrived at freely on the evaluation whether an alleged fact has occurred or not, see Case law of the Boards of Appeal of the EPO, 2022, 10th edition, III.G.4.1 and III.G.4.3.
Absolute conviction in the sense of certainty is and cannot be required. The jurisprudence refers to the “balance of probabilities” as the standard of proof to be generally applied, including in cases where the publication date of a poster is at stake, but recognizes that depending on the circumstances of the case, in particular if the evidence in support of a fact falls within one party’s sphere of influence, a stricter standard of proof “beyond reasonable doubt“, also referred to as “up to the hilt“, may apply.
However, as explained in the developing jurisprudence, also in case the determination is made on the basis of the balance of probabilities the facts on which any finding of public availability is based must be established with sufficient degree of certainty in order to convince the deciding instance in view of all the relevant evidence that they have indeed occurred, see T 545/08, Reasons 11.
In this context the board concured with the considerations in T 768/20, Reasons 2.1.2, with reference to Case law of the Boards of Appeal of the EPO, III.G.4.3.1, that the mentioned standards are both only fulfilled if the deciding body is persuaded that the alleged fact is true.
The proprietor’s argument, that only witness testimony could provide convincing evidence of what was actually presented at the conference in 2012 mentioned in document D9a, was not persuasive in view of the above mentioned principle of the free evaluation of evidence.
D9a identifies the poster of D9 as the content of the presentation to the public which it indicates to have taken place at a conference in 2012.
D9a represents convincing evidence of the publication date of the content of D9, considering that D9a as well as document D9 to which it refers originate from the sphere of influence of the proprietor, especially since the proprietor has not argued that the content of D9a is incorrect, let alone presented any evidence in support of such argument.
Accordingly, the board found no reason to doubt the publication of the content of D9 in 2012 as indicated in D9a.
Comments
The present decision does not go as far as T 1138/20, commented in this blog. T 768/20 was quoted in T 1138/20.
It was a good attempt of the proprietor to request for a witness to confirm the content of the poster, knowing well that this was barely possible, be it ony in view of the time lapsed.
From this series of decisions, and in view of the notion of free evaluation of evidence, one could concluded that the notion of balance of probability and beyond reasonable doubt could be merged into one standard: are facts related to the publication of a piece of prior art persuasive for the deciding body.
On the procedure
By quoting at least one X,P in its search report, the examiner in charge for the ED should have checked the validity of the priority. Validity of the priority was however never questioned, and only came up with the oppositions.
While the European search revealed some documents from the proprietor, the very relevant D9-D9a, also from the proprietor, was not found. D3 should also have been found during the initial search.
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