T 0172/20 - Commerical product as prior art

Key points

• Quotes from machine translation. " The Respondent [opponent] asserts that the commercial PSU polymers Ultrason® S 3010 and Ultrason® S 6010 described in A5 would anticipate the novelty of claim 3"
• " The Board cannot agree with the Respondent's line of argument "
• "The burden of proving lack of novelty thus generally lies with the opponent (ie the respondent). An exception to this rule would be where the polymer of claim 3 was defined by an unusual parameter [] However, this is not the case since the polydispersity [as specified in the claim] is a very common parameter for characterizing polymers,"
• For inventive step: "the question of whether there is a technical effect compared to the PSU polymers of A5 is controversial."
• "The appellant [patentee] is of the opinion that the technical problem is to provide improved PSU polymers which have improved mechanical properties, particularly when processed into hollow fiber membranes. In particular, it is shown in A20 and A22 that PSU polymers according to claim 3 have higher epsilon breaking values ​​than the PSU polymers of comparative examples V12 and V15, which each represent the PSU polymers "Ultrason® S3010" and "Ultrason® S6010"
• "the first question is whether comparative examples V12 and V15 actually represent the polymers "Ultrason® S3010" and "Ultrason® S6010". a) In the present case, the parties did not provide a direct comparison with "Ultrason® S3010" or "Ultrason® S6010". Instead, the appellant submitted, inter alia, the comparative examples C12 and C15, which would make such a comparison possible. "
• "The [patentee] asserts that the commerical products Ultrason® S3010 and Ultrason® S6010 advertised in document A5 are manufactured using potassium carbonate with a volume-average particle size in the range of 28 to 50 µm (see A21, penultimate paragraph). The PSU polymers of comparative examples V12 and V15 were produced using potassium carbonate with a volume-average particle size of approx. 35 μm and are therefore directly comparable with Ultrason® S3010 and Ultrason® S6010. "
• "The board notes, however, that the PSU polymers Ultrason® S3010 and Ultrason® S6010 are commercial products of the appellant. Knowledge of how these products were manufactured is therefore solely subject to the complainant's power of disposal and knowledge. In particular, the respondent and the board have no way of knowing under which process conditions and in particular with which potassium carbonate (if potassium carbonate was used) these PSU polymers were produced. Thus, for answering the present question (whether the comparative examples C12 and C15 are representative for Ultrason® S3010 and Ultrason® S6010), all the evidence is in the sphere of the [ patentee]."
• "[] when all the evidence is within the control of a party, a strict standard of proof must be applied (see Case Law of the Boards of Appeal, supra, III.G.4.3.2 b)). The principle of "complete" proof ("with a probability bordering on certainty") applies. In the present case, proof of the manufacturing process for the PSU polymers Ultrason® S3010 and Ultrason® S6010 must be provided with a probability bordering on certainty."
• "The Board therefore does not have sufficient evidence that the process for producing the PSU polymers Ultrason® S3010 and Ultrason® S6010 corresponds to the production process for the comparative examples of A22."
• " In the absence of suitable comparative examples with the PSU polymers of A5, the board must come to the conclusion that a technical effect compared to the products Ultrason® S3010 and Ultrason® S6010 has not been made credible. The objective technical problem is therefore to provide an alternative PSU polymer."
• The claims are held to lack an inventive step.
• As a comment, G 1/92 held that: "The chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person".
• Update 05.07.2023: this post was pre-scheduled and was not modified in view of G 1/23.

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

G 1/23 - Referral - Novelty of commercial products - Solar Cell ( T 0438/19)

Key points

•  The Board refers the following question to the Enlarged Board: "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 analysed and reproduced without undue burden by the skilled person before that date?"
• I like to think of this issue as the Coca-Cola ® question, see my post about T 1833/14 (from 2018). In fact, p.20 of the reasons refer to Coca-Cola. 
• Two further questions are referred: "2. If the answer to question 1 is no [i.e. the product is prior art], 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 analysed and reproduced without undue burden by the skilled person before that date?
• "3. If the answer to question 1 is yes [no prior art] or the answer to question 2 is no [brochure is only prior art if product can be reproduced], which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed 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 analysable and identically reproducible?"
• Claim 1 is directed to an ethylene/alpha-olefin copolymer, not to a solar cell also the title of the referral suggests. Unsurprisingly to readers of this weblog, the polymer is defined in terms of 6 parameters, being also results to be achieved. Incidentally, this is entirely conventional in this field because otherwise, basically, all ethylene/alpha-olefin copolymers are the same in terms of chemical composition. The Board carefully explains this aspect in point 13.1 of the reasons.
• The Board is of the view that "a decision as to whether the subject-matter of granted claim 1 involved an inventive step ultimately depended on the question of whether the (commercially available) product ENGAGE® 8400 had been made available to the public before the effective date of the present patent." D5 is a document "ENGAGE® 8400, Technical Information, Dow"; D5a is a Product Information sheet about the same polymer.  D1, Example 3, describes that ENGAGE® 8400 is suitable for the manufacture of solar cell modules.
• "According to the appellant [opponent] ENGAGE® 8400, an ethylene/1-octene copolymer having an MI of 30 g/10 min and a density of 0.870 g/cm**(3), fulfills all the requirements of claim 1, with the exception of the content of aluminium"
• "While the respondent [proprietor] does not dispute that ENGAGE® 8400 was commercially available and fulfilled all properties of claim 1 as granted, with the exception of the content of aluminium, it argued, relying on paragraph 1.4 of the Reasons for opinion G 1/92 and decision T 23/11, that the commercial product ENGAGE® 8400 had not been made available to the public within the meaning of Article 54(2) EPC."
• "diverging approaches by the Boards of Appeal exist with regard to the application of opinion G 1/92"
• G1 /92 r.1.4 reads as follows: "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".
• A possible interpretation is that: "a product put on the market becomes state of the art and therefore available to the public only when the composition or internal structure of the product can be discovered and reproduced without undue burden"
• However, " the Enlarged Board stressed in decisions G 2/88 and G 6/88 that the word "available" within the meaning of Article 54(2) EPC carried with it the idea that, for lack of novelty to be found, all the technical features of the claimed invention in combination must have been communicated to the public, or laid open for inspection. The mere fact that a product was put on the market would therefore appear to result in that product being laid open for inspection (and therefore "available")".
• "[T206/83 and T 26/85] convey the idea that the enablement of a disclosure is a necessary condition for this disclosure to have been made available to the public within the meaning of Article 54(2) EPC. In other words, a disclosure which is not enabling would not be comprised in the state of the art defined in Article 54(2) EPC. This appears also to be the rationale underlying the reasoning of the Enlarged Board in point 1.4 of the Reasons for opinion G 1/92."
• The referral decision is detailed, also studying the Travaux and recent case law. The full text can be found below. 

EPO 

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

T 0617/18 - Holding request inadmissible in examination appeal

Key points

• In this appeal against a refusal decision, the applicant files new auxiliary requests in appeal.
• The Board summons for oral proceedings, giving no preliminary opinion (yet). The applicant withdraws the request for oral proceedings. Can the Board hold the auxiliary requests inadmissible, or must the Board first invite the applicant to comment on the admissibility objections?
• The Board: " In the present case, the appellant withdrew the request for oral proceedings after being summoned thereto by the board. The appellant also informed the board that they would not attend these oral proceedings, even though the board had not provided any provisional opinion on the issues of the present case. 
• "The appellant could well have expected that the board maintains the decision of the first instance as regards the main request and that, as regards auxiliary requests I and II, their admission into the appeal proceedings would have to be first assessed by the board before entering into a detailed examination of all the substantive issues of these requests. The criteria for such assessment are well established in the case law and based on both procedural as well as substantive considerations (cf. "Case Law", supra, V.A.5.1.2, V.A.5.2.2, V.A.5.3, and V.A.5.11.4.a)). The appellant however did not take the opportunity, as they would have had, to discuss admission of the auxiliary requests at the oral proceedings.
• "Thus, in view of the appellant's behaviour and requests on file, the board considers that the appellant's right to be heard is not breached or infringed by the board not admitting appellant's new auxiliary requests I and II into the appeal proceedings (Article 113(1) EPC)."

EPO 

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

T 0795/21 - Deleting alternative from Markush formula

Key points

• Claim 1 is directed to a class of compounds ("A chemical compound having formula I"). The Board finds that claim 1 of the main requests lacks an inventive step over D36 (after an extensive analysis).
• Claim 1 specifies as one of the features "X is independently selected from the group H, F, Cl, Br, I, OH and methyl (-CH3)" and "Y is F".  The embodiment wherein X is H is found to be obvious because of structural similarity with D36 (with further reasons).
• The Board turns to Auxiliary Request 4. Herein, H is deleted from the list of alternatives for X. 
• In the application as filed, the definition was: "X and Y are independently selected from the group comprising H, F, Cl, Br, I, OH and methyl (-CH3)". Hence, in AR-4, H is deleted from the list for X and Y is limited to F.
• The Board recalls that according to established case law, for this type of amendment, Article 123(2) requires that "the amendment may not lead to a particular combination which is not derivable from the original application and is therefore potentially suitable to provide a technical contribution to the originally disclosed subject-matter as opposed to a mere restriction of the required protection which does not result in the definition of a new sub-class of compounds and is therefore not potentially suitable to provide a technical contribution to the original subject-matter." (T 615/95, T 859/94, T 50/97, T 783/09, T 948/02 and T 801/02) 
• As the amendment is made to restore inventive step, the proprietor argues that this case law no longer applies after G 2/10: the proprietor argues that "with reference to G 2/10 and T 1937/17 that the notion of a technical contribution should actually not be taken into account at all"
• The Board:  "amendments by the deletion of options from multiple lists of separate characteristics inherently include an aspect of combination and potentially involve an aspect of arbitrariness, which may complicate the assessment of whether such amendments remain within the limits of what the skilled person would directly and unambiguously derive from the original disclosure."
• The Board recalls that G 2/10 referred to the "body of jurisprudence ... with respect to cases in which the limitation could lead to the singling out of compounds or sub-classes of compounds or other so-called intermediate generalisations not specifically mentioned nor implicitly disclosed in the application as filed" and indicated that this body of case law was to be applied (r.4.5.4). 
• Therefore, the notions used in the existing case law, namely "mere restriction of the required protection" versus "generating another invention" or "suitable to provide a technical contribution to the originally disclosed subject-matter" are to be applied as considerations which may arise from the application of [the gold standard test] when assessing amendments by deletion of options from multiple lists and which may affirm the result of such assessment.
• "the Board considers that the observation that the deletion of options for X and Y in accordance with claim 1 of auxiliary request 4 is suitable to provide a technical contribution to the originally disclosed subject-matter supports the assessment that this amendment is not in compliance with the "gold standard".
• The technical contribution is provided by the amendment omitting the alternative that overlapped substantially with D36 and was held to be obvious. 
• "The Board therefore concludes that auxiliary requests 4 does not comply with the requirement of Article 76(1) EPC."
• As a comment, I wonder whether the allowability of the amendment here depended on the content of D36 as prior art. 
• The decision was taken 24.03.2023. On that day, the stock price of the proprietor decreased from 1.24 USD to 0.80 USD. The patent is EP2955190, also at issue in [2023] EWHC 611 (Pat) of 21 March 2023. That decision states that Sofosbuvir falls in the Markush group of the claims of the patent (at 11).

EPO 

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

T 2391/18 - No need to tidy up the description in opposition

Key points

•  "The allegedly required amendment to paragraph [0017] does not relate to any amendment to the claims during opposition proceedings. Instead, as set out above, this amendment relates to an alleged inconsistency that already existed in respect of a feature present in the granted claims."
• " Such an amendment to the description is not appropriate in opposition proceedings or opposition appeal proceedings. (....) [T]here is no reason for the Board (or the Opposition Division) to come to the conclusion that the requirements of the Convention (in particular the requirements of Article 84 EPC) within the meaning of Article 101(3)(a) EPC are not fulfilled. The reason for this is the conclusion of the Enlarged Board in G 3/14: in considering whether, for the purposes of Article 101(3) EPC, a patent as amended meets the requirements of the EPC, the claims of the patent may be examined for compliance with the requirements of Article 84 EPC only when, and then only to the extent that the amendment introduces non-compliance with Article 84 EPC."
•  "Since in a case such as the present one the amendment to the claims did not introduce an issue of non-compliance with Article 84 EPC, an opposition division or a board of appeal cannot examine the claims of the patent for compliance with the requirements of Article 84 EPC, including the requirement of "support by the description" in the second sentence of this provision. There is thus no reason for the Board to object to the wording of paragraph [0017] of the amended description as filed during the oral proceedings before the Board."

EPO 

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

T 1654/19 - The CPA should ideally

Key points

•  The Board, on the selection of the closest prior art: "t is established case law that the closest prior art should ideally be a document which mentions the purpose or objective indicated in the [patent under examination] as a goal worth achieving (Case Law, supra, I.D.3.2). The aim thereof is that the assessment process should be based on a situation that is as close as possible to that faced in reality by the inventor, avoiding ex post facto considerations."
  
  
• On the procedure: two opponents appealed. One later withdrew the appeal. The other opponent relies on the former appellant's earlier arguments in the appeal. 
• The Board: "The appellant and the other party [the other opponent] submitted that the claimed composition lacks an inventive step over D1, which was contested by the respondent.  From a procedural point of view, the respondent submitted during the oral proceedings that only opponent 1, as a former appellant and now other party, filed a reasoned objection starting from D1 as the closest prior art. Opponent 2, as the only remaining appellant, would have merely referred in the said letter ... to the submissions made in the statements of grounds of appeal of opponent 1, i.e. to the submissions of the former appellant and now other party. The respondent [patentee] considers that the objection of inventive step based on document D1 as the closest prior art is therefore no longer part of the appeal proceedings. This is not convincing. As recalled in decision T 1820/18 (point 4 of the Reasons), it is not possible to split the appeal proceedings into different procedures, each dealing separately with the grounds for opposition and the facts, evidence and arguments presented by the individual opponents concerned (T 790/03, point 2.1 of the Reasons). Therefore, each opponent can rely on any grounds, facts, evidence and arguments duly submitted by other opponents (see also T 620/99, point 1 of the Reasons; T 1657/14, point 2.4.3 of the Reasons)."

EPO 

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

T 0933/18 - (II) Poisonous priority

Key points

•  The appellants [opponents] argued that the method of claim 1 lacked novelty over the disclosure of the parent application (document D3) and document D5a.
• "because the method of claim 1 of the patent was not entitled to priority contrary to the disclosure of Example 3 of the parent application, the latter anticipated the claimed method due to a "poisonous priority"."
• It is however contested, whether or not decision G 1/15, [] applies to the present case at all,
• claim 1 as granted relates to a method for preparing a biosensor. This method comprises as an embodiment the use of GLD or variants thereof that lack any galactose, glucose, mannose and arabinose since the content of these sugars is defined as "10 myg or less per myg of protein", which includes 0 myg/myg GLD, i.e. a "sugar-free" GLD.
• I understand that the values for these sugars are not given in the example and that this feature is added compared to the priority document.
• " [if] the disclosure of a sugar-free GLD in Example 3 of the parent application (D3) falls necessarily within the subject-matter of claim 1, then this applies likewise to the sugar-free GLD of Example 3 of the patent application too. Moreover, since both Examples 3 are identical to Example 2 of the priority document (D4/D4a), claim 1's embodiment of a sugar-free GLD is present in the priority document too."
• "In light of these considerations, the embodiment of claim 1 using a sugar-free GLD for the preparation of a biosensor must be regarded as an "OR" claim as defined in G 1/15 (Reasons 5.2.1), since sugar-free GLD is an implicitly disclosed feature in Examples 2 and 3 of the priority document and the patent application, respectively. Consequently, this embodiment of claim 1 is entitled to partial priority (see decision G 1/15, Reasons 6.4). Therefore, the parent application (D3) cannot anticipate the claimed method."
• "A skilled person reading Example 2 of the priority application (and Examples 3 in the parent application and the patent application) [...] immediately understands that the GLD recombinantly produced in E. coli is sugar-free (i.e. not glycosylated) although this is not explicitly mentioned. The production of sugar-free GLD in E. coli is thus the clear and unambiguous consequence of the explicit disclosure of this working example in view of E. coli's generally known inability to produce glycosylated proteins. It is established case law that such a feature is implicit[ly disclosed]".
• This implies that the feature could be added to the example without violating Article 123(2) EPC.
• "It is uncontested that proteins recombinantly produced in E. coli are not glycosylated ("sugar-free", i.e. lack any galactose, glucose, mannose and arabinose residues as referred to in claim 1), because E. coli does not contain the enzymes required for glycosylation, i.e. for adding sugar residues to a protein. This belongs to the common general knowledge of the skilled person. Furthermore, the absence or presence of sugar residues on a protein are a structural feature of this protein."
  
  
• The decision also contains an extensive analysis of novelty over D5a, which is found to be a non-enabling document, and of inventive step over D5a. 

EPO 

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

T 0933/18 - (I) Agreeing with CPA, waiving attacks

Key points

•  "Appellant I [opponent] advanced two lines of arguments as regards a violation of right to be heard. Firstly, ...  secondly, no reasoning under inventive step was provided based on documents D15a and D23 as alternative closest prior art. Both failures deprived appellant I of the opportunity to give reasoned arguments on these issues."
• The Board: " it is established practice under the EPC to use the problem-solution approach to examine inventive step; according to this approach, the most promising document to arrive at the claimed invention, i.e. the closest prior art, should be selected in a first step. "
• "The case law has established that if a piece of prior art can be identified as the closest prior art or the most promising springboard and it can be shown that, starting from this prior art, the claimed invention is non-obvious, then the invention must be even less obvious starting from any other prior art. In these circumstances a detailed inventive step assessment starting from the other prior art document(s) can be dispensed with (see e.g. T 1742/12, Reasons 6.3)."
• "While document D15a was advanced by appellant I in their notice of opposition as an alternative starting point under inventive step (see page 38, point 4 to page 40, point 4.2), this line of argument was never referred back to, let alone further substantiated or defended in reply to the preliminary opinion of the opposition division"
• "The minutes of the oral proceedings report under inventive step on page 2, in point 5 that "After O1's request for a short break to deliberate on the strategy, OD announced a break from 15:10 to 15:20". After resuming the oral proceedings the minutes disclose that "all parties agreed on D5a as closest prior art document" (see page 2, point 5, emphasis added). Thus appellant I had been given the opportunity to consider their case and decided to continue with document D5a as the closest prior art. This course of events does not imply that appellant I maintained their line of arguments under inventive step based on document D15a. Nor are any other indications derivable from the documents on file in this respect."
• "As set out above, all parties agreed on document D5a as the closest prior art. There was thus no need for the opposition division to assess inventive step starting from any other prior art document. Therefore, appellant I's second objection is not convincing either."
  
  
• "Appellant II submitted a sweeping reference to the opposition case as regards further added subject-matter issues against claims 2 to 5 and 7 (see statement of grounds of appeal, page 7, point 2.5.3). Such a reference is insufficient for establishing why the contested decision should be overturned on this point. Under Article 108 EPC, Rule 99(2) EPC, and Article 12(3) RPBA 2020, appellant II has to present a complete case in their statement of grounds of appeal so as to allow the board and the other party to understand why the contested decision should be overturned without having to make any further investigations of their own (see, inter alia, T 1566/12, Reasons 20, and T 989/16, Reasons 1). Appellant II's submission against claims 2 to 5 and 7 is thus disregarded."
• As a comment, there is no concept of partial admissibility of the appeal under Rule 99(2) EPC. 

EPO 

The link to the decision is provided after the jump.

T 1225/19 - Proximity-based reminders

Key points

• The invention is essentially the idea of setting a reminder that is triggered if another person is nearby.
• "The entire scheme can be summarized by the following, purely administrative instructions: "please, remind the user of an action (item), when a contact which is involved in the action (item) is or will be close to the user, in order to realise the action (item)"".
• The Board considers the claims to lack an inventive step based on a straightforward application of the Comvik approach.
• "in addition to the non-technical features, the subject-matter of claim 1 includes technical features, in particular a "processor ... on an electronic device". Thus, the subject-matter of claim 1 relates to an invention within the meaning of Article 52(1) EPC."
• "The features defined in claim 1 represent a mixture of technical and non-technical features. An invention consisting of a mixture of technical and non-technical features and having technical character as a whole is to be assessed with respect to inventive step by taking account of all those features which contribute to the technical character whereas features making no such technical contribution cannot support the presence of inventive step (see T 641/00"
• "All [the technical] features as such are individually known and are also known as being, if necessary, integrated in a notorious computer system. This represents the technically skilled person's notorious knowledge."
• " When starting from a notorious computer system, like a PDA [personal digital assistant] , the business person provides the following purely administrative/business scheme as business constraints to the technically skilled person for implementation on the notorious computer system ... the following, purely administrative instructions: "please, remind the user of an action (item), when a contact which is involved in the action (item) is or will be close to the user, in order to realise the action (item)", whereby the board considers "action" and "action item" being equivalents."
• "Having this business scheme in hand, the skilled person, a software programmer, has to solve the objective technical problem of providing the computer implementation and automation of the above formulated business method in the notorious electronic device. The provided technical solution neither calls for a particular technical implementation nor provides a further technical effect beyond the straightforward computer implementation. In particular, the implementation of this business constraint ("please, remind the user, ... the action item") relating to the determination of the proximity of a contact and the user, is held by the board, contrary to the appellant's view, not inventive. "
• "features a) and b) derive immediately from the straightforward implementation of the non-technical business requirement mentioned above. All other features relating to the remaining steps of the computer implementation of the business scheme are also straightforward implementations since the technical means required for all these various procedural steps are well-known standard features and the definition according to claim 1 is technically unspecified. This is not disputed by the appellant. 
• Since the result of the straightforward implementation of the above cited business scheme is the method defined in claim 1, the board concludes that the subject-matter of claim 1 of the main request does not involve an inventive step "

EPO 

The link to the decision is provided after the jump. 

T 1621/21 - PSA is not mandatory

Key points

•  The Board: "While the use of the problem-solution approach is not mandatory because it is not always reasonably applicable, if it is not used, the examining division should have explained the reasons for not using it."
• " the appealed decision is seriously flawed because the examining division neither made a clear division of the features of claim 1 into technical and non-technical features nor properly applied the problem-solution approach. Therefore, the appealed decision must be set aside."
• "the examining division's finding that the subject-matter of claim 1 lacked an inventive step was not based on applying the problem-solution approach, comprising the steps of identifying the distinguishing features of claim 1 over the disclosure of the closest prior art, determining which distinguishing features are technical features and which are non-technical features, determining the technical effect of the distinguishing features which are technical, deducing therefrom the objective technical problem solved by the distinguishing features, looking for an incentive for the skilled person to solve the objective technical problem and analysing whether the solution as claimed was obvious in view of the available prior art."
• The Board nevertheless adds that: " claim 1 does not seem to comprise any feature which would exclude that the entire tailored sensory work is transmitted between the server and the playback device. Actually, claim 1 seems to cover the possibility of transmitting the entire sensory work between the server and the playback device. Therefore, the objective technical problem as stated by the applicant does not appear to be a valid objective technical problem solved by the distinguishing features."
• 
  

EPO 

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

T 0042/19 - Appellate review of findings of fact (V)

Key points

• Board 3.2.01 indicates that it does not consider the hearing of witnesses a regular part of the task of a board of appeal. 
• In August 2020, it issued T 1418/17, where it held that "a board of appeal should only annul the evaluation of the evidence of a first-instance department and replace it with its own if [the first instance department] recognizably (i) has failed to address material considerations,  or (ii) has considered factors that are irrelevant to the case, or (iii) reveals a violation of the laws of thought, such as logical errors and contradictions in the reasoning” or there is a mistake in the application of the law (e.g. an incorrect standard of proof has been applied)." According to that decision, this followed from the ‘principle of free evaluation of evidence’ under the EPC.
• Board 3.2.02 replied in T 1604/16 of December 2020 that "if the criteria set out in T 1418/17 were applied so broadly, this would amount to a considerable restriction of a board's competence. This kind of restriction may well be found in some national jurisdictions where the last judicial instance only reviews questions of law and the review of findings of fact is very limited. If there are several instances of judicial review, legislators might limit the second or further instance's power of review. However, there is no basis in the EPC or established case law for such a broad restriction of the boards' competence. ... On the contrary, the boards have competence to review appealed decisions in full, including points of law and fact (see e.g. explanatory remarks to new paragraph 2 of Article 12 of the Rules of Procedure of the Boards of Appeal, OJ Suppl. 2/2020). This is in accordance with Article 6 of the European Convention on Human Rights, which stipulates that there must be at least one judicial instance that can review a case in full, i.e. the law and the facts, given that the boards of appeal are the only judicial body to review decisions by the departments of first instance of the European Patent Office (regarding Article 6 ECHR, see e.g. Guide on Article 6 of the European Convention on Human Rights, Council of Europe/European Court of Human Rights 2013, paragraph 84).” (emphasis added)."
• Board 3.2.01 maintained its position in T 0041/19 and T 0239/20 without further explanations.
• Meanwhile, G 2/21 (post) held in r.32 that: "The principle of free evaluation of evidence may not be used to disregard evidence per se insofar as [the evidence] is admissibly submitted and relied upon by a party in support of an inference which is challenged and is decisive for the final decision".
• The OD rejected the opposition in the present case, considering the alleged public prior use unproven. No witness was heard by the OD. The opponent requested the hearing of witness with the Statement of grounds, in connection with the same alleged prior use. This request is rejected under Art. 12(4) RPBA 2007: "the Board is convinced that the request to hear Ms X as a witness could and should have been submitted in the first-instance proceedings".
• Thereafter, the question of the manner and standard of review of the factual findings of the OD remained. "The Board agrees with decision T 1604/16 that the boards' power to review appealed decisions is not limited to points of law but extends to points of facts (see Reasons 3.1.7 referring to, inter alia, the explanatory remarks to new Article 12(2) RPBA 2020). Thus, a board has the power and a duty to overrule decisions not only on the grounds of an incorrect application of the law but also on the grounds of deficiencies in the fact-finding process. "
• This illustrates that judicial dialogue is essential for developing a body of high-quality case law. 
• The Board then obiter held that: "it is settled case law that a board is not obliged to take all the evidence anew and that parties do not have the right to have the taking of evidence repeated at their request before the board" (no case law references are given).
• The Board then turns to the standard of review: "The boards usually just review the way in which the evidence was taken by the departments of first instance and, where they do not find any deficiencies, apply the law on the basis of the facts found in the decisions."
• In the terminology used in common law, this is not a de novo review but a deferential one. In my view, the EPC does not prescribe a deferential standard of review, nor does any decision of the Enlarged Board. The phrase 'to review the appealed decision' does not exclude a de novo review. 
• "the principle of free evaluation of evidence, meaning that there are no firm rules on the probative value of the various types of evidence but that the deciding body [i.e. the opposition division] is entrusted with weighing up all the evidence and basing its decision on what it is then satisfied has been established, implies a degree of freedom comparable to the one referred to by the Enlarged Board of Appeal in decision G 7/93, Reasons 2.6. "
• G 7/93 r.2.6 is, of course, the favourite holding of Boards and readers of this weblog alike: "if an Examining Division has exercised its discretion under Rule 86(3) EPC 1973  = Rule 137(3) EPC] against an applicant in a particular case and the applicant files an appeal against the way in which such discretion was exercised, it is not the function of a Board of Appeal to review all the facts and circumstances of the case as if it were in the place of the first instance department, in order to decide whether or not it would have exercised such discretion in the same way as the first instance department."
• This reasoning of the Board seems an innovative proposal.
• "it is wise [for the Board] to similarly respect this freedom [of the OD], especially when taking into account that a board, except when only reviewing documentary evidence [i.e. especially if a witness was heard, or an expert, or an object was inspected], does not have the same first-hand impression of the probative value of a means of evidence as a department of first instance that has itself heard a witness or expert or inspected an object."
• The Board is well aware that a board, being a deciding body as well, is also entrusted with the weighing of evidence under the principle of free evaluation of evidence. As a consequence, it cannot be excluded that a board might come to a different conclusion than the body that issued the impugned decision. But being under the obligation to give reasons for its decision, the board must be able to convincingly demonstrate where the competent division erred.
• As a comment, evidence newly filed or taken in appeal can also be a reason for reversing a factual finding (and is not excluded under Art. 12(4) RPBA 2020).
• However, the Board might have a point that, if the evidence is the same, a decision of the Board reversing a factual finding of the OD needs substantiation on that point. Then still, does not necessarily mean that the Board must show a (clear) error of the first instance division. 
• "Where this is possible, one of the criteria set out in decision T 1418/17 will most probably be fulfilled. Where this does not seem possible, a board should think twice whether there really is a need to overrule the evaluation of evidence contained in the impugned decision. Thus, the Board can acknowledge much of the reasoning in decision T 1604/16 but is still convinced that the test set out in decision T 1418/17 gives valuable guidance for identifying cases where a board is prompted to set aside an impugned decision's evaluation and either apply its own evaluation of evidence or remit the case to the department of first instance. "
• "Respecting the [first instance] department's evaluation of evidence in the remaining cases would both reflect and justify the standing practice, as outlined above, that the boards are not obliged to and regularly do not take evidence themselves but instead review the fact finding done by the department that issued the decision under appeal." (underlining added)
• As a comment, standing practice does not mean that the practice is correct.*  Moreover, the Board's approach to taking evidence themselves (or not) should follow from the rules and not the other way around. 
• * I could cite a judgement of the ECHR on the right to a fair trial that forced The Netherlands to change a standing practice of the police (not much to the great enthusiasm of the police themselves), but my concern is not about the specific case but about the general principle that (efficient) judicial practices must comply with the procedural rights of parties and the right to a fair trial, not the other way around. 
  
• "it should be kept in mind that the evaluation of evidence only refers to establishing whether an alleged fact has been proven to the satisfaction of the deciding body. The discretion-like freedom referred to in point 3.5 above is restricted to this question and does not extend to the further question of how the established facts are to be interpreted and what the legal consequences are. Thus, the fear that a board's power to review decisions might be unduly limited is not shared."
• "The Board is convinced that in this case none of the aforementioned circumstances which would justify a review of the evaluation of evidence carried out by the opposition division can be identified in the reasoning which led to the conclusion that the alleged public prior use D18 was not sufficiently proven. The reasons are as follows."
  
  
• As a comment, admissibility of requests for the taking of evidence (e.g. hearing of a witness) and standard of review are distinct concepts. Under the RPBA, any requests for the taking of evidence should be presented (normally) in the initial appeal submission and be substantiated. The first step for a party to challenge a "standing practice" of the Board is to request a witness hearing in appeal in a timely and substantiated manner.

• EPO 

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

J 0003/21 - Translation does not become original

Key points

• This is an appeal against a decision of the  Receiving Section; the case is anonymised. 
•  "On 29 September 2020, the applicants filed, in the Chinese language, European patent application EP XX XXX XXX.X including an abstract, a description and 25 claims, the latter numbered with Arabic numerals."
• "Alongside the Chinese application documents and the filled-out EPO Form 1001, i.e. still on 29 September 2020, the applicants filed, as a translation of the former, an abstract, a description and 15 claims in the English language, together with seven sheets of drawings with reference signs using Arabic numerals (e.g. "404") and, for each sheet, lettering using the Latin alphabet (e.g. "FIG.1")."
• " In a telephone conversation with the Receiving Section on 9 October 2020, the applicants were informed of the discrepancy between, on the one hand, the number of claims indicated in EPO Form 1001 and as translated (15) and, on the other, the number of claims in the Chinese original application (25). They were also informed of the missing drawings in this application."
• For the claims fees, the easy way out is to file a divisional application which should effectively only incur the filing fee. 
• The status of the drawings is, however, tricky.
• " In the request for grant of a European patent (EPO Form 1001), the applicants were identified, as was the Chinese filing language (box 5.1: "zh"). The number of claims was stated to be "15" (box 29), "as attached" (box 29.1). In the box designated for "Specification in admissible non-EPO language" (box B-1), "Chinese Original.pdf", "15 claims" and "drawing(s)" were indicated. In the two boxes designated for "Translation of specification", respectively "Specification EN.pdf" (box B-3) and "Drawings.PDF" (box B-4) were indicated, "
• The application is still not published (3 years after the filing); at least the decision is published anonymised without a link to the file. 
• The applicant requests, inter alia, " that the English application documents filed on 29 September 2020 be regarded as the application documents, upon abandonment of the Chinese version filed on the same day"
• However, established case law is that a translation does not become the original, as held in G 6/91, point 10 of the reasons,  "a translation cannot become the original; whatever the date on which it is filed it remains a translation, with all ensuing legal consequences", confirmed in T 1152/05 for the case of a Notice of appeal being filed in an inadmissible non-EPO language together with a translation in French (appeal deemed not to have been filed), idem T 0041/09, but see T 1037/11 point 1.20.
• For the drawings, T 0382/94 might be relevant, suggesting that the drawings are part of the application documents. 
• The Legal Board in the present case: "the request addressed in point 2 aimed at correcting at least the description of the originally filed Chinese application by replacement with at least that of the English translation filed on the same day. The ban on such corrections, established in G 2/95 on the basis of Article 123(2) EPC and further developed in e.g. J 5/06 and J 16/13, is categorical and follows from the principle reflected in Rule 40(1)(c) EPC that the accorded filing date is inseparable from the description as originally filed. An exchange of the description by way of correction would directly result in the separation of the filing date from the description in contravention of Article 123(2) EPC. "
• Note, in new Rule 56a(4) EPC, the correct parts are added,  not replaced, hence in full compliance with the letter of  G 2/95. See also the article of Mulder and Van Woudenberg in epi Information 3/2022.

EPO 

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

T 1328/20 - Endoxifen - Protocols for testing without actual results

Key points

• Claim 1 of the main request reads: "Claim 1 of the main request defined: "A composition comprising an effective amount of a complex comprising synthetic endoxifen, wherein said endoxifen is a free base or is in the form of a salt for use in the treatment or prevention of cancer by the oral mode of administration."
• "Document E1 reports results of in vitro assays for estrogen receptor binding, inhibition of estrogen stimulated breast cancer cell proliferation and regulation of estrogen responsive genes indicating that endoxifen has equivalent activity to 4-OH-Tam, which is known as a potent active tamoxifen metabolite [i.e. is a metabolite of tamoxifen, and is potent and active]."
• The abstract of E1, from 2004, can be found here; the authors are not the inventors of the patent:  https://link.springer.com/article/10.1023/B:BREA.0000025406.31193.e8. 
• The abstract includes: "We demonstrate that endoxifen has essentially equivalent activity to the potent metabolite 4-hydroxy tamoxifen (4-OH-tam) often described as the active metabolite of this drug [tamoxifen]. "
• "Tamoxifen is a nonsteroidal antiestrogen that has found successful applications for each stage of breast cancer in the treatment of selected patients. " (link, from 1992)
• The Board: "Document E1 does not describe a composition for use in the treatment or prevention of cancer by the oral mode of administration as defined in claim 1 of the main request."
• As a comment, it is unclear to me if the Board considers that E1 does not describe endoxifen for use in the treatment or prevention of cancer, or only fails to teach the oral administration.

• " the patent presents in example 10 results of in vitro experiments which are in line with the results from the experiments already described in document E1. In example 9 the patent further reports that mice can survive exposure to certain doses of intravenously administered endoxifen, whilst examples 11-15 relate to protocols for testing the effects of endoxifen following oral administration without presentation of any actual results."

• "In view of document E1 and having regard to the teaching in the patent the Board considers the objective technical problem as the provision of an effective and convenient administration form for endoxifen in the treatment of cancer."
• Note, the formulated problem does not refer to safety, so the additional example 9 regarding mice safety is not apparently considered. Hence, possibly, providing in vitro results that are "in line" with the in vitro results of  E1, is seen as solving the problem of  "the provision of an effective ... administration form", or the protocols that are presented without results, or some information added in the general part of the description (which uses claim-like language instead of the language used in the scientific paper E1).
• Note, apparently, the presented in vitro results are considered to be sufficient proof that an effective administration form for endoxifen in the treatment of cancer is provided (together with any other technical information in the patent); though it must be borne in mind that the Board found the claimed subject-matter not inventive even when seen as solving this problem..

• The Board: " In view of the pharmacological activity of endoxifen as known from document E1 and taking account of the well known convenience of oral administration the Board considers that the skilled person would, in the absence of any prejudice against oral administration of endoxifen, regard the claimed subject-matter an obvious solution for providing a convenient and effective mode of administration for endoxifen in the treatment of cancer."

• A detailed discussion follows whether there was a technical prejudice "against effective oral administration of endoxifen." The Board considers such prejudice not proven after a detailed review of the (technical) evidence.

• The appeal of the proprietor is dismissed, and the patent remains revoked.

• As it stands, the Board does not need to comment on the holding of G 2/21 (which was issued a few days before the present decision was taken) that for second medical use claims, "it is necessary that the patent at the date of its filing renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application". 

• 
  

• Of course, whether the in vitro assay results are sufficient for meeting that requirement of G 2/21 can be a matter of debate requiring great expertise in the technical field at issue.

   

  EPO 

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

T 1193/21 - Review of decision to admit

Key points

• In this opposition appeal between two repeat players in the detergent business, the Board only has to deal with admissibility.
• The proprietors appealed.
•  "The appellants requested not to admit this document although it had been admitted into the proceedings by the opposition division and the decision was based on it."
• "In the jurisprudence there is also no consensus as to whether this is possible at all under the EPC. While some boards have decided that, at least in cases of an abuse of discretion, the discretionary decision to admit a document can be overturned even if the decision is based on that document (e.g. T 960/15; T 1652/08; T 572/14 or T 2197/11), other boards have decided differently (e.g. T 617/16, point 1.1.1 of the reasons, and T 2337/16, point 4.2 of the reasons)."
• "In the current case, this question can remain open because in the board's view, the opposition division exercised its discretion according to the right principles and in a reasonable way."
• D18 was "filed four days before the oral proceedings before the opposition division and providing supplemental information with regard to the ink used in [experimental report] D14 [filed by the opponents]. "
• "experimental report D14 [of the opponents] was filed with the grounds of opposition, and this, if the proprietors had indeed wanted to replicate the experiments, they could have requested the opponent to disclose which ink had been used already with the reply to the opposition. However, no such request had been made. Moreover, in view of paragraph 0047 of the patent, which states that the type of ink is not particularly limited, and further taking into account that the examples of the patent do not disclose which ink had been used either, there was no reason for the opponent to specify the type of ink used in D14."
• "the appellants [patentees] stated that they had decided to deal only with the fundamental deficiencies of D14 instead of presenting all corresponding objections when filing the reply to the notice of opposition. In particular, they explained that they saw no need for any counter experiments at that stage because D14 was seen as very weak evidence for the reasons given in the reply to the opposition."
• "the board observes that the principles of procedural economy and fairness of the proceedings require a party to present all aspects of its case as soon as possible, in particular in inter parte proceedings, since the parties have a duty to facilitate the swift conduct of the proceedings inter alia by submitting all relevant facts, evidence, arguments and requests as early and completely as possible"
• " if a party decides to present an aspect later in the proceedings, it must bear the consequences of this decision. In the current case, it was only with the submission [] one day before the final date for making submissions under Rule 116 EPC and two months before the oral proceedings [] that the proprietors disclosed in very general terms that non-aqueous solvent based inks had been used in the experiments of the patent and that they requested the opponent to disclose the type of ink used in D14. This information having been provided in D18, its filing thus constitutes a direct response to the request of the proprietors."
• "The [patentees] further argued that it would have been incumbent on the opposition division not to admit D18 or at least to postpone the proceedings on its own motion, in order to give the proprietor the possibility to replicate the experiments, thereby ensuring that the proceedings were conducted fairly. The appellants held that it was not their duty to request a postponement because they "could not be expected to accept and accommodate the procedural consequences" of the late filing of D18."
• "These arguments are however not convincing because from the way the proprietors had conducted the proceedings, the division had no reason to assume that they intended to carry out such experiments. In this context, the board emphasises that experimental evidence filed by one party is by no means always contested with counter experiments by the other party. Therefore and given the circumstances of the case, it could not be expected from the division to postpone the proceedings. Rather, it would have been incumbent on the proprietors to request a postponement in order to carry out replication experiments. However, no such request was made."
• 
  
• "" The appellants challenged the contested decision only in that Dll and D18 should be declared inadmissible, that D14 should be disregarded and that D16 and D17 should be admitted into the proceedings. As the board does not follow either request, the appeal cannot succeed."
• 
  

EPO 

T 1079/18 - Febuxostat II and III

Key points

•  This is another patent directed to Form I of Febuxostat , now having the additional feature that it is a pharmaceutical composition "wherein the at least one pharmaceutically acceptable excipient is selected from the group consisting of fillers, sweeteners, buffering agents, glidants, flowing agents, flavouring agents, lubricants, preservatives, surfactants, wetting agents, binders, disintegrants and thickeners."
• The filing date is in 2011.
• The Board comes to the same conclusion:  "by performing a DSC analysis of form A, the skilled person aiming at higher solubility would have identified form I as being the desired form, i.e. a higher-melting form that results from form A by an endothermic phase transition at higher temperatures. In view of the heat-of-transition rule, they would have expected form I to be an enantiotrope of form A and form I to have a higher solubility than form A at temperatures below the transition temperature (somewhere between approx. 175 and 200 °C), i.e. at ambient temperature. Further, the fact that form I merely retains the non-hygroscopicity of form A (in the absence of a comparison, one cannot speak, at any rate, of an improvement - see above) can be considered merely as a bonus effect that the skilled person inevitably achieves because they are primarily looking for a crystalline form of febuxostat with higher solubility."
• The claims are found to be obvious, and the patent is revoked.
• In decision T 0546/21, a separate patent for a method using the crystalline form to prepare a pharmaceutical composition is also revoked. 
• Oral proceedings in cases T 1065/18 and T 1079/18 were joined and lasted until 18:00; oral proceedings in case T 0546/21 were held the next day and took only an hour. 

EPO 

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

T 1219/19 - Patentee was notified of the objection

Key points

• The preliminary opinion of the OD was, cautiously, that Art. 123(2) was met. During the oral proceedings, the OD changes of opinion. Must the OD admit a new auxiliary request filed during the oral proceedings in response to this change of opinion?
• The present Board states that "under Rule 116(2) EPC, requests filed after the final date set for making written submissions in preparation for oral proceedings can only then not be admitted if the patent proprietor had been notified of the grounds prejudicing the maintenance of the patent."
• However, the Board still does not overrule the OD's decision to hold the request inadmissible.
• "the board found that under the circumstances in hand the opposition division was entitled to exercise its discretion accorded by Article 123(1) in conjunction with Rule 81(3) EPC to disregard the auxiliary request at issue (see R 6/19, Reasons 6 to 11; T 966/17, Reasons 2.2.1; T 1213/19, Reasons 19). 
• "It further found that the opposition division had exercised its discretion in accordance with the right principles, primarily the clear allowability criterion. The opposition division could not have been deprived of that discretion merely because it expressed a different opinion at the oral proceedings from that provisionally set out in the communication accompanying the summons (see also T 966/17, Reasons 2.4).
• "The opposition division's preliminary opinion discussed the added-matter objections raised by the opponents and clearly indicated that those objections were to be the subject of further discussion at the oral proceedings: ""
• "The preliminary conclusion that claim 1 does not add subject-matter (see points 1.3 and 1.5) is expressed in a careful manner ("Currently the opposition division is of the opinion that ..." and "... the opposition division is of the preliminary opinion that ...") and cannot be understood as if the opposition division thereby gave up its discretionary power to disregard submissions filed later."
• I suppose the argument of the opponent is not that the OD gave up its discretionary power, but that Rule 116(2) EPC takes away / limits the discretionary power.
• The opponent points out that the GL state that: "The ... opposition division has the discretion to disregard amendments filed after the date set under Rule 116(1) as being late-filed unless they have to be admitted because the subject of the proceedings has changed" and that "The following are examples of what would normally constitute a change of subject of the proceedings: ... the examining or opposition division departs from a previously notified opinion: for example, contrary to its preliminary opinion set out in the annex to the summons, the opposition division concludes during oral proceedings that an objection prejudices the maintenance of the patent. .... In these examples, a request from the applicant or proprietor for a corresponding amendment cannot be rejected as being late-filed even if submitted after the date set under Rule 116(1). "
• My quotes are from the GL 2023, the decision states that the GL 2022 is cited therein but the text seems to be that of the GL 2023.
• The Board notes in passing that "the Guidelines applicable at the time the opposition division took its decision (version in force in November 2018) did not contain this particular example"
• More importantly, the Board reasons as follows: "the question of whether a change of opinion represents a change of subject of the proceedings remains crucial in the matter in hand. The board agrees that, in principle, it does change the subject of the proceedings, especially where the opposition division introduces a new objection at a relatively late stage. However, the cited passage of the Guidelines refers to examples that would normally constitute a change of subject of the proceedings. It therefore does not exclude the possibility that, under particular circumstances, a change from the preliminary opinion does not necessarily involve a change of subject of the proceedings. The board finds that in the case in hand, the content of the preliminary opinion, taken as a whole, is articulate and cannot be read in a manner limited to the conclusion in point 1.5 (that claim 1 does not add subject-matter), as the appellant has done. On the contrary, it should also be read in consideration of the discussion under point 1.3 (both referred to in points 40. and 40.1 above). The objection that the single-molecule sequencing process had no basis in the parent application had been raised by both opponents at the outset of the opposition proceedings - it was not introduced into the proceedings by the opposition division. The issue had been discussed at length in preparation for the oral proceedings, it had been considered an issue by the opposition division in the preliminary opinion (see point 1.3) and it was also sufficiently clear that it was a crucial one. The appellant [patentee] therefore could not have been surprised by the decision taken at the oral proceedings. It appears that the appellant [patentee] had indeed been notified of the grounds prejudicing the maintenance of the patent."

EPO 

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

Visser's Annotated EPC 2023

• I'm glad to share that the new edition (2023) of Visser's Annotated EPC is now shipping.
• You can order the paper book on the Kluwer website here.
• If your firm has a subscription to Kluwer IP Law, the online version is available at: https://www.kluweriplaw.com/document/TOC_Visser_AEPC 

T 1065/18 - Febuxostat I / Preparative DSC

Key points

• In this post: polymorphs, a bonus effect, and a try-and-see situation. As well as clarity issues. 
• Claim 1 reads as follows (amendments shown vis-à-vis claim 1 as granted):

  "Crystalline form of Febuxostat having an X-ray powder diffraction pattern as [follows], further characterized as being an anhydrous form [...]"

• ""Pharmaceutical composition comprising a crystalline form of Febuxostat [having a certain X-ray powder diffraction pattern] wherein the pharmaceutical composition is packaged or filled into a container.""

• The compound referred to in claim 1, febuxostat, is a medicament used in the treatment of hyperuricemia and gout. 

• " The feature according to which the pharmaceutical composition "is packaged or filled into a container" is not contained in the granted claims. Hence, with respect to this additional feature, claim 1 of auxiliary request 2 is open to an assessment under Article 84 EPC "

• " Although the claim features in their entirety define the claimed subject-matter, a claim may nevertheless be unclear. In the board's view, this is the case here. Due to its wording ("Pharmaceutical composition ... packed or filled into a container."), claim 1 puts the emphasis on a pharmaceutical composition rather than a container comprising said composition. This makes it unclear whether the protection sought is limited to the pharmaceutical composition per se, or whether a container comprising a pharmaceutical composition is to be protected (see T 352/04, point 2.8 of the Reasons for a similar case).

  Thus, claim 1 of auxiliary request 2 lacks clarity. Auxiliary request 2 is not allowable."

• Auxiliary Request 4: Claim 1 reads "Pharmaceutical composition comprising a crystalline form of Febuxostat ..., wherein the pharmaceutical composition is an oral dosage form."

• It was common ground between the parties that D2 is the closest prior art. The board saw no reason to deviate from this unanimous view. D2 relates to solid forms of febuxostat, referred to as crystalline forms A, B, C, D and G, and as amorphous form E. [the crystalline form specified in the claims is yet a further form].

• "The subject-matter of claim 1 is distinguished from form A of D2 in that - it relates to a pharmaceutical composition in oral dosage form [and] - the pharmaceutical composition comprises form I rather than form A. "

• The Board carefully formulates the objective technical problem.

• " With regard to the assessment of obviousness, the board considers it appropriate to first summarise the following aspects concerning polymorphs relevant to the present decision (for useful overviews: D9, page 532, right column, second paragraph; D11, chapter III on page 18 f. and table 4; D17, paragraph bridging pages 166 and 167; D27, pages 11 ff.; A38, pages 2437 f. and 2446 to 2449; A39, pages 186 to 188; A45, pages 97 ff.). There was agreement between the parties that these aspects belong to the skilled person's common general knowledge.

  - The transition between two polymorphs can be categorised as either enantiotropic or monotropic." [follows an extensive technical analysis].

• "Against the background of this common general knowledge, the skilled person, faced with the problem of providing a crystalline form of febuxostat that has a higher solubility than form A, will clearly be inclined to check whether form A undergoes an endothermic phase transition into a new higher-melting form at higher temperatures. This is because, according to the heat-of-transition rule, such a new solid form should then be an enantiotrope of form A having a higher solubility than form A below the transition temperature, such as at ambient temperature in the present case (see point 12.3 above). Either such a form exists or it does not. The board concurs with opponent 1 that the skilled person would have been in a "try and see" situation."

• "It may be true that the skilled person - as argued by the patent proprietor - does not generally think of using DSC to find new solid forms. However, against the background of the common general knowledge summarised above and the objective technical problem, they would most certainly have done so - if only because DSC measures heat flow and is the method of choice for determining exo- and endothermic processes when heating a sample."

• The Board gives an extensive analysis of the evidence on file regarding DSC.

• "Thus, by performing a DSC analysis of form A, the skilled person aiming at higher solubility would have identified form I as being the desired form, i.e. a higher-melting form that results from form A by an endothermic phase transition at higher temperatures. In view of the heat-of-transition rule, they would have expected form I to be an enantiotrope of form A and form I to have a higher solubility than form A at temperatures below the transition temperature (somewhere between approx. 175 and 200 °C), i.e. at ambient temperature. Further, the fact that form I merely retains the non-hygroscopicity of form A (in the absence of a comparison, one can, at any rate, not speak of an improvement - see above) can be considered merely as a bonus effect that the skilled person inevitably achieves because they are primarily looking for a crystalline form of febuxostat with higher solubility."

• The patent is revoked.
  
  

EPO 

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

J 0009/21 - Interruption of proceedings

Key points

•  The OD revoked the patent on 05.02.2018. The proprietor appeals. On 19.07.2019, the proprietor informed the legal division that an external administrator had been appointed on 26.09.2016 (!).
• " the Legal Division declared that the opposition proceedings had been interrupted as from 11 November 2016 (i.e. as from the day after the expiry of the opposition period) and that the proceedings would be resumed on 4 November 2019. By submission dated 24 October 2019, the opponent requested that the Legal Division set aside the interruption of the proceedings or, alternatively, that it set 21 February 2017 as the date of resumption of the proceedings. After issuing a communication and holding oral proceedings, the Legal Division issued the decision under appeal."
• "the Board agrees with the finding in T 1389/18, Reasons 4, that the Legal Division has the power to determine an interruption of the proceedings, which was as a result also confirmed in J 10/19, Reasons 6."
• I.e. even during a pending appeal. 
• "The Legal Division's finding in view of the documents annexed to the respondent's submission dated 19 July 2019 that an external administrator was appointed in line with the provisions of the Australian Corporations Act was not contested by the appellant. Under the Australian Corporations Act, a company may be placed into external administration if it is experiencing financial problems. In such a situation, an external administrator may, as in the present case, be appointed voluntarily by the company's directors, or involuntarily by its creditors. In both cases, the interests of creditors are involved. "
• "Once appointed, voluntarily or involuntarily, according to Section 437D of the Australian Corporations Act only the external administrator can deal with a company's property. Any transaction or dealing affecting company property is void if it is not entered into or consented to by the administrator (unless the transaction or dealing was entered into under an order of the court). This also corresponds to the external administrator's letter to the former patent proprietor's solicitor dated 29 September 2016, in which he stated that all active files and actions now "fall under my control".
• "the mere fact that there was no bankruptcy judgement and that the former patent proprietor entered voluntarily into external administration under the Australian Corporations Act does not speak against the application of Rule 142(1)(b) EPC in the present case. Rather, as the disputed patent was part of the former patent proprietor's company property at the relevant point in time, the former patent proprietor was indeed "prevented by legal reasons from continuing the proceedings" within the meaning of Rule 142(1)(b) EPC. The Board also notes that the company placed into external administration was ultimately liquidated."
• "If the relevant conditions are fulfilled [as is the case], an interruption of proceedings under Rule 142(1)(b) EPC occurs directly by operation of law. Hence, the Legal Division's communication dated 26 July 2019 on the interruption of proceedings was not constitutive in this regard; rather, it only had declaratory effect (see T 854/12, Reasons 1.1.1)."
• "the effect of an interruption of proceedings is not limited to certain periods being interrupted as specified in Rule 142(4) EPC. Rather, after the interruption has taken effect, procedural acts undertaken by the parties which do not concern the situation created by the interruption - like in the present proceedings the question of whether there actually was an interruption - are invalid. The same principle applies to acts, including decisions, taken by the EPO during the time of interruption."
• "Whether or not the patent proprietor continued the opposition proceedings factually during the period of interruption is irrelevant under Rule 142(1)(b) EPC, as this provision is only concerned with whether the patent proprietor was legally able to continue the proceedings (see T 1389/18, Reasons 8, last sentence). [...] The interruption of proceedings under Rule 142(1)(b) EPC by force of law rather ensures that acts undertaken by applicants or patent proprietors which continue the proceedings even though they are not legally allowed to do so are invalid - and therefore cannot be detrimental to the legitimate interests of third parties."
• The Board found that abuse of procedure by the patentee was not evident. The patentee's letter of 19.07.2019 was not intended as a request for an interruption but submitted in the context of registration of an assignment, as I understand the decision. 
• The Board recalls that " Whether proceedings "shall be interrupted" under Rule 142(1)(b) EPC is not a discretionary decision of the deciding body (J 18/12, Reasons 10). Rather, an interruption of proceedings only depends on whether or not the conditions referred to in Rule 142 EPC are met"
• " it is not possible to set aside a declaration of interruption by the Legal Division with retroactive effect, not even if it was declared erroneously (for an interruption see T 1389/18, Reasons 6, and J 10/19, Reasons 4 to 13; for a stay see J 14/19, Reasons 3.5, with further references). "
• "the present Board notes that it seems to follow from the aforementioned case law that the effects of an interruption under Rule 142(1)(b) EPC can come into existence not only as a matter of law at the time of, and due to, the fulfillment of the conditions for an interruption under Rule 142(1)(b) EPC, but also - and in such cases indeed retroactively - through an erroneous declaration of interruption by the Legal Division."
• The Board notes that in some cases, the Legal Division must hear the parties before declaring an interruption. "This is particularly so if (almost) entire opposition proceedings have been conducted during the relevant period. In such cases, the expected legal consequences of the interruption may indeed require the Legal Division to hear the parties before issuing a declaration of interruption."
• " In T 1389/18, Reasons 7, it was accordingly held that the decision announced by the opposition division during the period of interruption was null and void. In the present case, it will be up to the Technical Board of Appeal in case T 967/18 to assess this matter."

EPO  J 9/21

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