T 0500/16 - Plausibility attack not admitted

Key points

•  Claim 1 is directed to the crystalline malate salt of the known pharmaceutical compound cabozantinib.
• As to novelty: “D29 [" EMEA; Committee for Orphan Medicinal Products; December 2008, Plenary Meeting Monthly Report"] (page 1) discloses cabozantinib (L)-malate for treatment of medullary thyroid carcinoma (a thyroid cancer). D29 only refers to the malate salt without stating whether it is crystalline. While D29 implicitly discloses that the salt is in a solid form, it cannot be deduced from D29 that the salt is crystalline. The subject-matter of claim 1 of the main request, referring to the crystalline form of a cabozantinib malate salt, is therefore not directly and unambiguously derivable from D29.”
• For inventive step: “The objective technical problem ... is the provision of a cabozantinib malate salt which, as a pharmaceutical formulation, has an improved dissolution profile under physiological conditions.”
• As to obviousness: “The above documents only show that crystalline forms of pharmaceutical solids are preferred. However, none of the above documents includes any teaching on how to improve the dissolution profile under physiological conditions of the cabozantinib malate salt. This is not disputed by the appellants. In the absence of such a teaching, the solution provided by claim 1 of the main request is thus not obvious.”
• This reasoning may be an illustrative example of the problem-solution approach being effect-centred. 
• “In the current case, it has been shown in annex 1 that the unexpected property of the claimed compound is an improved dissolution profile under physiological conditions. Thus, the case at hand does not correspond to the situation in case T 777/08 where no unexpected property was recognised.”
• The opponents argue that the found effect is a bonus effect (which hence does not provide for inventive step): “[The opponents] argued that the improved dissolution profile under physiological conditions of the crystalline form of cabozantinib (L)-malate was a mere bonus effect since the skilled person would have had ample motivation in view of the teachings of D3, D5, D7, D13, D14, D25, D26, A005 and A006 to select the crystalline form of cabozantinib (L)-malate, the compound disclosed in D29.”
• “The board does not agree. A "bonus effect" arises when the state of the art forces the skilled person to adopt a certain solution, the lack of alternatives leading to a "one-way street" situation. In such a situation, any additional effect does not necessarily contribute to inventive step (see e.g. T 405/17, reasons, 4.3.3). However, this situation does not apply in this case for the following reasons. [follows a detailed review of cited prior art] In view of the above disclosures and teachings, there is no indication in the prior art that in searching for an adequate solid form of the compound disclosed in the closest prior-art document D29, the skilled person would have been forced specifically to choose only the crystalline form of cabozantinib (L)-malate as required by claim 1 of the main request. Thus, the improved dissolution profile under physiological conditions of the crystalline form of cabozantinib (L)-malate, as shown in annex 1, cannot be considered a mere bonus effect.”
• The Board also rejects that the case at hand was an obvious-to-try situation.
  
  
• Then,  to plausibility: “With the statement of grounds of appeal, [opponent] submitted that it was not made plausible on the basis of the content of the application as filed that the claimed compounds achieved the effect shown in annex 1, namely the improved dissolution profile. Therefore, the post-published data of annex 1 were not to be taken into consideration in the formulation of the objective technical problem. This objection is referred to below as the "plausibility objection".”
• The patentee requested that this objection be not admitted. The opponents in turn “requested that the respondent's request for non-admittance of appellant 2's submissions on a lack of plausibility not be admitted into the proceedings.”
• “The board decided to admit the respondent's request [i.e. admissibility objection] into the proceedings [under Art. 13 RPBA 2007] for the following reasons [follows a consideration of factors such as procedural economy].
• The “plausibility objection” is not admitted under Art. 12(4) RPBA 2007. “In the proceedings before the opposition division, the parties had discussed the data presented in annex 1 as to their merits, i.e. the parties had proceeded on the basis that the data could be taken into account and the decision under appeal is based thereupon. ”
• The Board: “Admitting the objection into the proceedings would have given appellant 2 a new chance, after opposition proceedings which had been instituted by it and having been terminated, to object to inventive step based on an entirely new submission. The admittance of the plausibility objection would have led to an entirely fresh case regarding inventive step. More specifically, had the plausibility objection been admitted and found convincing, the post-published data in annex 1 would have had to be disregarded, and the effect relied upon by the respondent could not have been taken into account. The objective technical problem would thus have changed, and the obviousness as regards a different objective technical problem would have had to be considered for the first time during the appeal proceedings.”
• “[The opponent] argued that the submissions on plausibility did not constitute an allegation of fact but rather an argument and that the board did not have any discretion not to admit an argument.”
• “The board does not agree. The appellant's allegation was that the application as filed did not make it plausible that the claimed subject-matter resulted in an improved dissolution profile. Whether, on the basis of the application as filed, it can be concluded that a certain effect, here an improved dissolution profile, is plausible or not is based on a factual consideration rather than a mere argument. More specifically, numerous facts play a role in making this consideration, such as what is actually disclosed in the application as filed as regards the effect and what the technical relationship between the claimed compound and the effect is. Therefore, appellant 2's submissions on plausibility included an allegation of fact (see also T 1875/15, reasons, 2.3 to 2.4), and the board had under Article 114(2) EPC the discretion not to admit appellant 2's late-filed submissions.”
• The opponent further argues that plausibility was a new issue in the case law. The Board seem to accept that new case law can be a valid reason for admitting a submission, but finds that the issue of plausibility was in fact not new in 2013-2015 (proceedings before the OD) in view of T 415/11 (reasons, 50, 12 January 2012), T 1329/04 (reasons, 12, 28 June 2005). 

EPO - T 0500/16 

Link to the decision after the jump, as well as an extract of the decision text.

T 1287/18 - Devolutive effect of appeal

Key points

• The Board gives first a useful summary of the relationship between the principle of party disposition, the extent of appeal, and the devolution effect of appeal. 
• The Board: “In accordance with the principle of party disposition [...] the power of a board to decide a certain matter depends on the extent of the appeal and covers only that part of the impugned decision which is indicated in the statement of grounds as actually challenged by the appeal. The extent of an appeal is simultaneously the limit of the devolutive effect, the latter indicating that the first instance loses its competence for the further prosecution of the matter”
• Now the difficulty is, what do we mean with “that part of the impugned decision which is indicated in the statement of grounds as actually challenged by the appeal”?
• In the following paragraph of the present decision, the Board suggest that a “part” may refer to a part of the reasons. I'm not sure if that is the correct approach. 
• “In the present case, the decision has been appealed [by the opponent] in respect of novelty with regard to the finding of the opposition division that novelty over D1 was given ("extent of the appeal"). The opposition division found that the criteria for selection inventions apply and that the range 5-14 wt% of an ethylene/1-butene elastomer of claim 1 of auxiliary request V met those criteria. This finding has been impugned by the appellant [opponent] on the argument that the criteria for selection invention were not met. Since the Board was of the opinion that the opposition division did not apply the correct criteria for assessing novelty, it was within its power to mention it and to indicate which criteria should be applied.”
•  “Contrary to the appellant's [opponent's] argument, the Board in doing so is not carrying out a general review (de novo) of the first instance decision, regardless of what has been sought by the parties, in contrast to the teaching of G 8/91 (point 10.2 of the reasons). Indeed, considering that the appellant sought the review of the first instance decision to the extent that novelty over D1 was given, the Board has the power to review that part of the decision in full without any limitation. This is also in line with the primary object of the appeal proceedings to review the decision under appeal in a judicial manner (as now explicitly stated in Article 12(2) RPBA 2020), in the sense that they primarily serve to verify the correctness of the result of the decision under appeal, i.e. the legal effect of that decision.”
• G 8/91 is about withdrawal of appeals (finding that the appeal proceedings are immediately terminated if the sole appellant withdraws the appeal) and the cited paragraph 10.2 reads, in part: “As a matter of general principle, it is not the function of the Boards of Appeal to carry out a general review of decisions at first instance, regardless of whether such a review has been sought by the parties. On the contrary, the Boards' function is to consider appeals that are admissible and pending.”
• Returning to the question, what is the “extent of appeal”, it must be borne in mind that parties may not appeal if reasons are unfavourable. E.g. if the patent is revoked as novel but not inventive, the opponent may not appeal (and cross-appeal, i.e. an appeal in reply to an appeal by patentee is not possible); accordingly clearly the patentee can not limit the extent of appeal to the issue of inventive step only. In other words, the patentee appeals the decision to revoke in full. If there is a 2nd ancillary decision in the order of the first instance department (e.g. an apportionment of costs under Art. 104), the appellant can limit the appeal to one of the decisions in the order, see T 420/03. 
• Admittedly, in T 233/93 held that: “As appellant I [opponent] only objected to those parts of the impugned decision which relate to product claims the Board is not authorised to question the patentability of the process claims.”
• Turning to the present case, in my view, the appeal of the opponent is simply directed to the decision as specified in the order, that taking into account the amendments made by the patent proprietor, the patent and the invention to which it relates are found to meet the requirements of the EPC. 
• The Board writes that: “This is also in line with the primary object of the appeal proceedings to review the decision under appeal in a judicial manner (as now explicitly stated in Article 12(2) RPBA 2020), in the sense that they primarily serve to verify the correctness of the result of the decision under appeal, i.e. the legal effect of that decision.”
• As a comment, this touches on the key question: is the purpose of appeal proceedings to verify the correctness of the result of the decision of the appeal, or of the reasons for the decision under appeal? Note, that the first alternative would imply that new attacks in appeal should be considered: if the new attack prejudices the result of the impugned decision, e.g. the patent is maintained as granted, then the Board should consider any attack that can prejudice that result. 

EPO - T 1287/18

Link to the decision after the jump, as well as an extract of the decision text.

T 2713/17 - Cancelling independent claims no case amendment

Key points

• This decision provides yet a further contribution to the debate between the Boards about the question of whether cancelling independent claims constitute a case amendment.
• In recent decision T 2091/18 issued in writing 15.12.2021, Board 3.2.05 found that: “Für den Rückschluss, dass die Streichung von Ansprüchen das Beschwerdevorbringen nicht ändere, insofern sich dadurch keine geänderte Sachlage (T 995/18, T 981/17, T 1792/19, T 1857/19) bzw. keine (völlige) Neugewichtung (T 995/18, T 981/17) ergebe, findet sich nach Ansicht der Kammer in der Verfahrensordnung keine Stütze.”
• So Board 3.2.05 found it to be a case amendment.
• The present Board 3.2.06, in a decision taken 30.11.2021: “By submitting the new main request, the respondent's [patentee's] action did not give rise to any new issues requiring discussion but, on the contrary, merely restricted its requests then on file to subject-matter which had already been discussed and on which the Board had already given its conclusions [ that this claim fulfilled the requirements of the EPC]. ... The Board concludes that under these special circumstances, the submission of the new main request does not constitute an amendment to the party's appeal case in the sense of Article 13 RPBA 2020. The requirement for exceptional circumstances of Article 13(2) RPBA 2020 to exist is therefore not applicable. This is also in line with a body of case law developed by the Boards, see e.g. T1480/16 (Reasons 2) and T981/17 (Reasons 3).”
• The request is admitted.
• The new clarity objection is not admitted.
• The Board finds the claim to be allowable. “The Board thus avails itself of its power under Article 111(1) EPC to remit the case to the opposition division for the description to be adapted to the amended claim.”

EPO -  T 2713/17 - 

Link to the decision after the jump, as well as an extract of the decision text.

T 2002/19 - Forfeiture of attacks

Key points

•  This decision touches on a rather subtle point of waiver though more precisely, perhaps, forfeiture of objections (in the sense of the RPBA 2020, i.e. of attacks).
• The opponent presented new inventive step attacks with the Statement of grounds against AR-2 filed during the oral proceedings before the OD. The Board does not admit these attacks under Art. 12(4) RPBA, under the prong that they should have been filed earlier, which in turn raises the question if the opponent was reasonably expected to submit the attacks during the first instance proceedings. The opponent submitted some other attacks against AR-2 before the OD; the Board considered the merits of these attacks and found them not prejudicial to the claims at issue. 
• The Board, in machine translation: “The then opponent and current appellant expressly did not deny the admissibility of the then auxiliary request 2 and the current main request and did not criticize its late submission at the oral hearing, so that this request was not a surprise and consequently the new objections do not constitute an appropriate response to a surprising submitted request”
• “At the end of the inventive step discussion, the chairman [of the OD] made sure that no party would like to comment further on the subject”, i.e. the chair of the OD enquired if the opponent wished to present further inventive step attacks.
• The question here is: what exactly is the link between these observations of the  Board, and the phrase “should have been submitted ... in the proceedings leading to the decision under appeal” in Art. 12(6)(s.2) RPBA 2020? Why exactly is it relevant that the opponent did not protest against the admissibility of AR-2?
• Possibly, by not protesting against the admissibility of AR-2, the opponent waived/forfeited the argument that it was not in a position to fully discuss inventive step of AR-2 during the oral proceedings before the OD. Possibly by indicating that it did not wish to present further attacks, when asked by the chair, the opponent waived/forfeited the argument that the course of the oral proceedings had prevented it from presenting the attacks during the oral proceedings. 
• I use the terms ‘waiver’ and ‘forfeiture’ as in USA appellate procedure (link) "Forfeiture and waiver are two concepts that U.S. courts apply in determining whether reversible error has occurred. Waiver is the voluntary relinquishment, surrender or abandonment of some known right or privilege. Forfeiture is the act of losing or surrendering something as a penalty for a mistake or fault or failure to perform, etc.". Hence, forfeiture seems to apply to the present case. 

EPO - T 2002/19

Link to the decision after the jump, as well as an extract of the decision text.

T 1786/16 - Art. 13(2) RPBA and Art. 113(1)

Key points

• The patentee complains that the Board did not admit an auxiliary request under Art. 13(2) RPBA.
• The Board, on the relation between Art. 13(2) RPBA and Art. 113(1) EPC, in translation: “Article 13 (2) RPBA 2020 does not contradict the parties' right to be heard enshrined in Article 113 (1) EPC, even if the modified submissions of a party in the appeal proceedings are not taken into account. With this provision in the Rules of Procedure of the Boards of Appeal, the legislature has made it clear that a submission in appeal by a party who does not fulfill his obligation to promote the proceedings can be wholly or partially disregarded at a later stage in the proceedings. Article 13 (2) RPBA 2020 does not limit a participant's right to be heard. According to Article 113 (1) EPC, a party must in any case be given an appropriate opportunity to bring his case before him. Therefore, Article 13 (2) RPBA 2020 also provides that if there are exceptional circumstances, such as a new objection raised for the first time in the communication of the Board or in the oral proceedings before the Board, the strict approach of this provision is not adhered to should be. However, the party involved must not have failed to use the opportunity given to them to make a statement as early as possible for reasons for which the party is responsible. 
• “In addition, the parties involved in inter partes proceedings should be given the opportunity to make statements under comparable conditions. The admission of subsequent case amendments of a party must therefore not lead to the other side being surprised or disadvantaged in their right to comment, for example because they can only insufficiently exercise this right in the time available (see also Article 13 (3) RPBA 2020).”
• As a comment, the opportunity to comment is not necessarily given only after the Board decides to admit the submission. Rather, parties are supposed to reply on the merits prior to the Board deciding on the admissibility, as the present decision in fact also illustrates (patentee should have filed the auxiliary request before the Board decided on the new Art. 123(2) attack submitted by the opponent with the Statement of grounds). 

EPO 

Link to the decision after the jump, as well as an extract of the decision text.

T 2796/18 - Rule 28(2) after all

Key points

•  The AC decided, under the former President, that Rule 28(2) was to apply also retroactively to applications already pending on 01.07.2017. The present decision concerns an appeal against the refusal of such an application on the sole ground that "the subject-matter of claim 1 was therefore excluded from patentability pursuant to Article 53(b) EPC and Rule 28(2) EPC"  because the claimed plants were exclusively obtained by means of an essentially biological process, which was not disputed.
• The Enlarged Board in G 3/19 did not opine on the validity of Rule 28(2) at all. Rather, the Enlarged Board changed their interpretation of Article 53(b) EPC. That new interpretation does not apply to applications already pending on 01.07.2017, the Enlarged Board held. This leaves open to some extent whether Rule 28(2) and Article 3 of that AC decision (OJ 2017 A56) is valid. 
• The Technical Board of Appeal in the present decision: "as the present application was filed before 1 July 2017, and is still pending (see section I), the new interpretation of Article 53(b) EPC adopted in opinion G 3/19 (supra), does not apply. Furthermore, Article 53(b) EPC, as interpreted by decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal (supra), does not exclude the subject-matter of the main request from patentability. In view of the above considerations, the board concurs with the appellant that the subject-matter of the claims is not excluded from patentability pursuant to Article 53(b) EPC in conjunction with Rule 28(2) EPC." 

EPO T 2796/18 - 

Link to the decision after the jump, as well as an extract of the decision text.

T 0325/16 - (II) New crystalline form inventive

 Key points

•  Patents direct to salt forms, solvate forms, and polymorphs are commercially rather important in the pharma field. T 777/08 held that "in the absence of any technical prejudice and in the absence of any unexpected property, the mere provision of a crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step." This decision is generally seen as raising the bar for this kind of "follow up" pharma patents.
• “pharmaceutical polymorphs provide an excellent way for a company to further protect a small molecule drug in order to recoup the billions of dollars that go into research and development, thereby enabling further research and development” (link, emphasis added) 
• In the present case, the Board finds the claimed crystalline forms to be inventive.
• " The [opponent] respondent also relied on T 777/08 in its inventive-step analysis. In this decision, the board held that the skilled person, starting from the amorphous form of an API as the closest prior art, would have gained a clear expectation from the common general knowledge that a crystalline form of it would have provided a solution to the problem of providing a product having improved filterability and drying characteristics. This expectation was considered reasonable because, although it could not be assumed that every single crystalline form would solve the problem, it could be assumed that many of these crystalline forms would. In view of this, the board considered the provision of a specific polymorph from the group of equally suitable candidates to be arbitrary and not involving an inventive step (T 777/08, point 5.2 of the Reasons)." 
• The Board: “The current case differs not only in that the closest prior art discloses a crystalline rather than an amorphous API, but also in that the skilled person would not have gleaned from it a reasonable expectation of success in solving the problem of providing crystal forms of CNDAC-HCl that are more stable than others. This is because the mere suggestion to look for more stable forms cannot be considered a reasonable expectation to find a specific solution, let alone a pointer.”
• “ the board essentially accepts the appellant's submission based on decision T 1684/16” thereby finding that “Only if the prior art either contains a clear pointer that the claimed subject-matter solves the objective technical problem or at least creates a reasonable expectation that a suggested investigation would be successful, can an inventive step be denied. ”
• “ It is true that it is in the common general knowledge of the skilled person to screen for polymorphs of an API to find one having improved properties such as an improved stability. However, this alone is not sufficient to deny inventive step to a solution by which this improvement is achieved.”
• “In the case at hand, there is no disclosure in the cited prior art creating any expectation, let alone containing any pointer, that the type I or type II crystals of CNDAC-HCl defined in claims 1 and 2 of the main request could be more stable than other crystalline forms of CNDAC-HCl. There is no suggestion that the crystal types I and II of CNDAC-HCl are more stable than others. While D3 mentions the solvent system EtOH-Et2O to be used for crystallisation, it gives no details on the stability of the crystal form obtained. The mere mention of the solvent system in D3, therefore, would not have given a reasonable expectation to the skilled person, let alone a pointer, that its use would have led to crystalline forms of CNDAC-HCl which are more stable than others.”
• The present decision seems to suggest that any polymorph with good or improved properties is inventive, since it can not be predicted in advance which crystalline form in particular will have good properties.

T 0325/16 -