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).