R 0005/13 - An opponent is not entitled to be heard on inventive step attacks starting from other documents

Key points

• R 5/13 was issued in 2014, i.e. before this blog started. Still, it warrants a post, partly based on Mr. Bausch's article on the case.
• The opponents are petitioners and complain that "the Board applied the problem-solution approach wrongly in allowing only one document as the starting point for discussing inventive step, where the case law allowed for more than one document to be considered as the closest prior art and for a discussion of lack of inventive step starting from any of those documents. That denial implied an infringement of the right to be heard according to Article 113(1) EPC." 
• The Enlarged Board:  "the petitioners argue that they should have been allowed to discuss all the issues of inventive step of any stage of the problem-solution approach in respect of all possible starting points they wished to rely on, despite the fact that the Board structured the discussion by first establishing which document or documents constituted the most promising starting point for an obvious development leading to the invention. In this, the Board ... by doing so ... systematically applied the standard method of the problem-solution approach." 
• " In the present case, the Board considered that the case could be decided in respect of the issue of inventive step by systematically applying the problem-solution approach stage by stage. Thus, it systematically limited its decision-making and accordingly the discussion with the parties to determining the closest prior art first, before discussing the other aspects of the inventive step of the subject-matter claimed according to the patent proprietor's first auxiliary request.
• Consequently, the Enlarged Board does not follow the petitioners' argument that the Board was obliged to let them continue to argue on the alleged lack of inventive step starting from document D1 despite the Board's conclusion not to take that document as the closest prior art and starting point for the further discussion of inventive step."
• " Since the petitioners were given the opportunity to submit their arguments with regard to the issue of determining the closest prior art, their right to be heard has been observed. Once the Board had reached a substantive conclusion by already excluding one or more documents (here: documents D1 and D11) as starting points for the assessment of inventive step, it was logically consistent to exclude all other prior art not found to be the closest prior art as starting point for the further discussion of inventive step according to the second and third stages of the problem-solution approach.
• " By following this methodology the Board did not infringe the right to be heard, because - as indicated above - a party* is not entitled to be additionally heard on the application of the problem-solution approach starting from other pieces of prior art than the closest prior art." (underlining added)."  (* - i.e. opponent, as is clear from the context)
• As a comment, this decision seems to reflect the established case law on the procedural aspect of the CPA rule. As a further comment, I'm not sure if the Enlarged Board's position will be the last word on the matter. 

EPO R 0005/13

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0454/18 - Proof of internet publication

Key points

•  The opponent produced sufficient evidence in 2015 of a web publication in 2006 (before the priority date) by a combination of web.archive.org print screens (showing a link to a PDF file) and an affidavit from an author stating that the PDF wile was published in 2005 and was never changed.
• " According to the affidavit S19 by [Mr. H], founder of [H] Ultrasonic LLC and author of document S13, document S13 was added in December 2005 to his website, thus publicly available from that moment on. Further, according to his affidavit, no changes were made to document S13 after December 2005." 
• " there is no reason to believe that the author of document S13 in his affidavit is not telling the truth. He appears to be an independent person who does not seem to have any business, economic or other relationship with any of the parties involved in the proceedings. Nor did the appellant contest the validity of the affidavit. There is also no convincing reason not to believe the author's statement in his affidavit that document S13 is unchanged since December 2005.
• " Secondly, the probability that the Internet links functioned correctly is estimated to be higher than the opposite. There is no reason to provide Internet links which do not function. The probability that the Internet links worked correctly, but that the wayback machine "web.archive.org" in its random crawls did not arrive at the lowest hierarchical page S18 earlier than 2 May 2006, is estimated to be higher than the opposite. Given the affidavit, it also seems unlikely that a version published in December 2005 had different content from document S13." 

EPO T 0454/18

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 2377/18 - CPA and binding effect starting point

Key points

• This decision illustrates the substantive aspects of the choice of the starting point document for the problem-solution approach. 
• It is a basic feature of the PSA that one document (or embodiment) is taken as the starting point and that obviousness of the claimed invention is analysed in view of the distinguishing feature of the claimed invention in view of that document and in view of the objective technical problem solved by that feature. The objective technical problem can generally be formulated as "how to modify the starting point document so as to achieve the technical effect", the technical effect being the effect achieved by the distinguishing feature, in the context of the claimed invention, compared to the starting point document.
• In the present case, the patentee argues that D1 is not the CPA.
• The Board (al quotes in translation): " In this sense, the [patentee's] arguments against the selection of D1 as the closest prior art seem to imply that the problem and solution approach must be applied based on only a single prior art document or exemplary embodiment, namely from the one to be initially selected closest prior art. This is not consistent with established case law." 
• The Board: "If the person skilled in the art has several viable paths, i.e. paths starting from several different documents or exemplary embodiments that could lead to the invention, the boards of appeal have consistently held that the ratio of the problem-solution approach requires the invention to be examined in relation to all of these paths before inventive step is acknowledged. If the [claimed] invention is obvious to a person skilled in the art in at least one of these ways, it is not inventive. If the inventive step is denied, the choice of starting point does not have to be specifically justified" 
• This is indeed established case law and was already indicated by Szabo 1986.
• However, the choice of the starting point document is important, as far as substantive aspects are concerned. In the present case, the claim was directed to a hood furnace (also translated as a bell annealer), in any case a batch design; D1 was about a continuous furnace. 
• " The board agrees with the appellant that the basic structure of a conventional bell annealer plant is part of the specialist knowledge of a person skilled in the art. However, such bell annealer furnace systems are structurally fundamentally different from the continuous heat treatment system disclosed in D1. The expert faced with the above task would therefore have no reason to combine the different building constructions. Even if he wanted to combine them, he had no idea how the well-known bell annealer systems could be integrated into the continuous furnace at D1. To do this, he would have to completely redesign D1's heat treatment facility in an unknown way. 
• " In addition, according to the settled case law of the Boards of Appeal (supra, I.D.3.6), the selection of the closest prior art not only defines the subject matter serving as a starting point, but also defines the framework for further development, namely a further development within this genus. A change from the consciously chosen type to another, previously known but not selected other type during the further development (i.e. here from continuous furnaces as disclosed in D1 to bell annealers) can then only be regarded as the result of an ex post facto analysis." 
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EPO T 2377/18

The link to the decision is provided after the jump break.

T 0582/19 - Lapse of patent in all states

Key points

• Rule 84(1) provides that: "If the European patent has been surrendered in all the designated Contracting States or has lapsed in all those States, the opposition proceedings may be continued at the request of the opponent filed within two months of a communication from the European Patent Office informing him of the surrender or lapse. "
• The general view is that the verb "may" implies that the proceedings can be terminated even if the opponent files the request, in certain cases.
• The present Board, in machine translation: "With regard to the request for continuation of opposition appeal proceedings under Rule 84(1) and Rule 100(1) EPC, filed within the time limit, the board exercises its discretion to allow this request. The legitimate interest asserted by the appellant [opponent]  to revoke the patent in full within the framework of these proceedings is inherent for the appellant opponent here, since the lapse of the patent in the [contracting states] is only effective ex nunc, while the revocation is effective ex tunc."
• This may be different if the patent is surrendered in all states and surrender has retroactive effect under the national law of all designated states wherein the patent is validated.
• See also my comments on T 1959/15. 

EPO T 0582/19

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 1732/18 - Phase I clinical trial data do not kill patent

Key points

• It seems there were 15 opponents in this pharma case. The file is almost 9.000 pages. 
• The decision is dated 27.10.2021 and was notified 16.05.2022. No notice of delay in issuing the written decision as prescribed in Art. 15(9)(a)(s.2) RPBA is visible in the online file.
• " The therapeutic application is defined in claim 1 as the "treatment of a thromboembolic disorder administered no more than once daily for at least five consecutive days". ...  It is implicit in this feature that the treatment has a clinical benefit, in particular that it is effective. Since a treatment without acceptable safety cannot realistically be considered as having a clinical benefit, the aspects of both efficacy and safety have to be taken into account to determine whether the treatment defined in claim 1 is disclosed in the prior-art citations relied on by the respondents (see also decision T 2506/12, Reasons: 2.8)." 
• " Since claim 1 concerns a further medical use, attaining the claimed treatment benefit is a functional technical feature of the claim. To meet the requirement of sufficiency of disclosure, the suitability of the treatment for the claimed therapeutic indication must therefore be disclosed unless this was already known to the person skilled in the art.'
• " The application as filed contains experimental evidence on this account in example 1 (see pages 11 to 14). Example 1 reports on a phase II study carried out to test the safety and efficacy of different dosage regimens of rivaroxaban, including the once-daily oral administration of 30 mg in the form of rapid-release tablets, in the prevention of venous thromboembolism in patients undergoing total hip replacement. The application reports that the efficacy and safety of this treatment were found to be in (approximately) the same range as standard anticoagulant therapy with enoxaparin" 
• " This evidence and the conclusions expressed in the application are presumed credible in the absence of evidence to the contrary."  
• " The respondents [opponents] did not provide any experimental counter-evidence obtained with rivaroxaban that might have called the results of example 1 into question or might have shown that the treatment according to claim 1 could not be carried out in any particular embodiment." 
• "the board considers that the information provided in the application as filed renders the medical indication of claim 1 of the main request credible. As a consequence, post-published evidence is not required but may also be considered [note: for sufficiency]. According to this evidence, as summarised in the appellant's document D121, subsequent phase II and phase III studies demonstrated the clinical efficacy and safety of the claimed dosage regimen at various od doses in both the prophylactic and therapeutic treatment of thromboembolic disorders, and several of these applications, falling within the ambit of claim 1, subsequently received regulatory approval."
• For these reasons, the ground for opposition under Article 100(b) EPC does not prejudice maintenance of the patent as granted.
• Regarding inventive step: " At the priority date, the entirety of published clinical data on rivaroxaban was phase I data. It was common ground that the conference abstracts D2 and D11 represented the closest prior art."
• " Both D2 and D11 mention the investigated drug compound only by its internal project code name "BAY 59-7939". The appellant's argument that D2/D11 do not provide enabling disclosure of the active compound does not succeed since the person skilled in the art would have found no difficulty in looking up the chemical identity and preparation of "BAY 59-7939" in the appellant's further publications on this compound. " 
• " the features distinguishing the subject-matter of claim 1 from the disclosure of D2/D11 are the use of tablets and the medical use [note: i.e. clinical benefit] achieved with a specified dosage regimen (namely, once-daily dosing of rapid-release rivaroxaban for at least five consecutive days)." 
• " Tablets are a conventional dosage form. The appellant did not base its reasoning in favour of inventive step on the choice of tablets over other dosage forms (e.g. capsules)." 
• " The issue to be decided under obviousness is whether the skilled person would have had an incentive and reasonable expectation of clinical success regarding the specific regimen defined in claim 1, i.e. once-daily dosing of rapid-release rivaroxaban for at least five consecutive days, in patients, i.e. subjects at heightened risk for thromboembolism.' 
• " The board considers that the disclosure of D2/D11 by itself, or in light of common general knowledge, would not have provided motivation to the person skilled in the art to pursue clinical testing of a once-daily regimen of rapid-release rivaroxaban in patients, for the following reasons.' 
• [follows some extensive reasoning by the Board]
• "  In summary, the serious concerns about safety in the case of a new anticoagulant did not warrant a "try-and-see" attitude for the dosage regimen, and the known, relatively short, half-life of rivaroxaban would not have supported an expectation of success with regard to once-daily dosing of rapid-release rivaroxaban." 
• " the skilled person setting up a phase II clinical trial of a new anticoagulant was not in a routine "try-and-see" situation. Without a reasonable expectation of success with regard to clinical efficacy and safety, the mere wish for patient convenience would not have been sufficient as an incentive for testing an [once daily] regimen of a rapid-release form of the drug.' 
• The claims are held to be inventive.

EPO T 1732/18 - 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 2766/17 - Statements in the description contradicting the plain claim wording

Key points

• "It is established case law that if the patentee amends its claims, it has to bring the description into line with them (see decision T 977/94 [] ).
• "The Board is aware of decision T 1989/18, in which the competent Board considered that the provisions of the EPC did not require the adaptation of the description to the subject-matter as claimed (points 4 to 13 of the Reasons)."
• "The current Board [agrees] that for the purposes of Article 84 EPC, the claims must be clear in themselves. However, if the description cannot be relied upon to resolve a clarity issue in a claim, this does not imply that, a contrario, clarity of the claim cannot be affected if the description contains statements contradicting the plain wording of the claim.
• "A patent specification is a unitary document disclosing and explaining an invention to the person skilled in the art. Article 84 EPC and Rule 42(1)(c) EPC expressly link the claims and the description for the purpose of disclosing the invention. Hence, the patent specification has to be considered as a whole for understanding the claimed invention as a solution to a technical problem."
• "In some cases, the drafter may choose to give a term a special meaning so that the patent specification becomes its own dictionary [internal citation omitted]. Hence, statements in the description contradicting the plain claim wording may cast doubts as to the intended meaning of this wording. It is the Board's view that under such circumstances, an objection under Article 84 EPC has to be raised.
• The Board in the headnote: "Statements in the description contradicting the plain claim wording may cast doubts as to the intended meaning of this wording. Under such circumstances an objection under Article 84 EPC has to be raised."
• Turning to the amended pages of the description at hand: "The amendments bring the description into conformity with the amended claims by making clear the non-optional character of the feature that the cast edible film is self-supporting. This is in compliance with Article 84 EPC."

EPO T 2766/17

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0339/19 - Interpreting Art. 13(2) RPBA (and legal peace)

Key points

• Art. 13(2) RPBA is a provision that requires some interpretation for its correct application, in my view. In this decision, Board 3.3.06 analyses the meaning of Art. 13(2) in some detail. 
•  Board 3.3.06: "The board holds that the new request qualifies as an "amendment" to the proprietor's case, as it indeed changes the factual and legal framework thereof. While filed as a reaction to the preliminary opinion of the board, the latter did not raise any points of fact or law that had not already been discussed or addressed in the framework of the opposition proceedings. [...] The board thus cannot establish "exceptional circumstances" when giving these words their ordinary meaning, and such reading of Art. 13(2) RPBA would lead to the result that the request should not be admitted. The board is aware that many decisions of the Boards of Appeal have indeed interpreted the term "exceptional circumstances" in this manner."
• "Yet this board takes the view that Art. 13(2) RPBA, as in fact all provisions of the Rules of Procedure, needs to be read and interpreted in the light of the overarching principles by which appeal proceedings are guided. In taking this approach, the board finds most helpful guidance in decision T 1294/16 of 10 March 2021, where the board concerned was faced with a situation comparable to the one at issue.
• "The present board finds itself in complete agreement with the above-cited passages, namely that the term "exceptional circumstances" should be interpreted in light and in application of the principles underlying the rules of procedure. The board would like to add that these principles have been developed by the boards of Appeal in connection with the right to be heard (Art. 113 EPC), the right to oral proceedings (Art. 116) and the right to a fair hearing both under Art. 6 European Convention of Human Rights (as per decisions G 1/05 (OJ 2007, 362), G 2/08 of 15 June 2009, T 1676/08 of 9 March 2012 and R 19/12 of 25 April 2014) and Art. 125 EPC (T 669/90 of 14 August 1991, headnote). The right to be heard also relates to the right to introduce and have heard evidence as defined in Art. 117 EPC, T 2294/12 of 12 January 2016, point 1.1. of the reasons. Art. 114(2) EPC however clarifies that such right to introduce new facts or evidence is not unfettered, but rather limited to their timely submission."
• "In each case where new facts or evidence are introduced, it is thus incumbent on the deciding board to balance the right to be heard with the public interest of doing justice in good time. The board is further in agreement with decision T 855/96 of 10 November 1999 that emphasises the position of the boards as the only judicial instance in proceedings before the European Patent Office and accentuates the need for public acceptance of its decisions ...
• [As held in T 855/96] "It serves legal peace and the acceptance of decisions rendered by the Boards of Appeal, and takes into account the importance of the boards' role as the only judicial instance that when deciding on the patentability of a patent with effect for all designated Member States, decisions should take into account the complete submissions made in appeal proceedings. Thus, a document submitted at the appeal stage should be taken into account unless completely irrelevant where its consideration can be justified from a point of view of procedural economy." (translation of quote of T 855/96 by the Board)
• "In taking the above principles as an interpretative guidance for the term "exceptional circumstances", the board decided to admit the main request because neither did its admittance compromise the procedural rights of the appellant/opponent in that issues beyond the current framework of appeal proceedings had to be discussed, nor did it lead to delays that would have compromised the interests of procedural economy."
• The Board finds the request at issue to be allowable.

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EPO  T 0339/19

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.