T 0951/19 - The OD changes opinion, opponent should request postponement

Key points

• The Board, in translation: "During the oral proceedings before the opposition division, the opponent requested that the filed auxiliary request 1 not be admitted due to late submissions, since the changes made were taken from the description and their subject-matter was surprising .
• However, the opposition division admitted auxiliary request 1, filed during the oral proceedings, into the opposition proceedings. The requirements of Rule 80 EPC and Article 123 EPC are met and the changes are [...] not surprising for the opponent [according to the OD]."
• Acccording to the opponent, the auxiliary request at issue involved significant differences compared to an earlier auxiliary request and was hence surprising.
• "In the present case, the opposition division took the preliminary view in its summons that granted claim 1 was new compared to E1 and changed this view at the oral proceedings after extensive discussion with the parties. The admissibility of auxiliary request 1, which was then filed, was discussed during the oral proceedings and both parties were heard, see points 41 to 48 of the minutes. The opponent also does not deny having been heard by the opposition division on the admissibility. She has not argued that the opposition division had not given her sufficient time, nor has she requested that the oral proceedings before the opposition division be interrupted or adjourned. To that extent the present case is different from T 789/83
• In T 789/83, the OD proposed amended claims of own motion (as they did in those days) and "[a]fter submitting the proposed amended Claim 1, the Opposition Division gave the parties ten minutes for studying the suggested version of Claim 1". This was a substantial procedural violation.
• I assume that the  Board refers to the opponent not requesting a break or adjournment of the oral proceedings after the OD decided to admit the auxiliary requests in the procedure. 
• "The board is therefore of the opinion that there has been no violation of the right to be heard and that the opposition division exercised its discretion correctly and also justified it in the decision under appeal,"
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• EPO 

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

T 1825/21 - Inventive crystalline form

Key points

•  The Board finds a crystalline form to be inventive.
• Claim 1 is directed to the compound ceritinib in free base form (i.e. not in the form of a salt).
• the subject-matter of claim 1 of the main request lacked inventive step starting from D1 as the closest prior art.
• the ceritinib HCl of example 7 of D1 is amorphous, and represents the disclosure in D1 which is structurally closest to the claimed crystalline ceritinib. This amorphous ceritinib HCl represents the starting point for the assessment of inventive step of the claimed crystalline ceritinib.

• the subject-matter of contested claim 1 is distinguished from this embodiment of D1 in that it concerns: - ceritinib in free base form, rather than as its HCl salt, - in crystalline, rather than in amorphous form.

•  the board acknowledges that the patent - or the application as filed, respectively - does not comprise any data comparing the claimed crystalline ceritinib with the amorphous ceritinib HCl of D1 [.] The board nevertheless concludes that the technical effects mentioned below may be accepted as being credible on the basis of the information in the patent and the common general knowledge of the skilled person.

• ", it is credible on the basis of this common general knowledge, which was known before the priority date of the claimed invention, that the effects of stability and ease of drying, demonstrated in the patent for crystalline ceritinib, represent improvements over the amorphous ceritinib HCl disclosed in D1. Therefore, an improvement over amorphous ceritinib HCl of D1 is acknowledged without taking the appellant's post-published evidence into account as proof of said improvement (supra). It follows also that case G 2/21 [still pending at the time of the decision], in which this issue is addressed, is not relevant to the present appeal case."

• The objective technical problem starting from the amorphous hydrochloride salt of D1 is hence the provision of a form of ceritinib having improved stability and ease of drying.

• "The appellant argued that the skilled person attempting to obtain a form of ceritinib with improved stability and ease of drying would have tried to prepare the ceritinib HCl known from example 7 of D1 in crystalline form. However, as set out in point 5 of D23, a declaration of a technical expert, any attempt to prepare ceritinib HCl only resulted in amorphous (i.e. non-crystalline) precipitates having chloride levels inconsistent with a stoichiometric salt.

  The board agrees. Having failed to solve the above problem in the most obvious way by providing a crystalline ceritinib HCl, there would have been no reason for the skilled person to turn to ceritinib free base in the expectation that it would provide a solution. "

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• EPO 

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

T 0215/20 - Dapagliflozin - plausibility requirement for prior art

Key points

• "claim 1 is directed to second medical uses of a crystalline solvate of [the compound] dapagliflozin with water and (S)-propylene glycol which comprises these three constituents in equimolar amounts (1:1:1 molar ratio) [;  for use in treating a disorder selected from diabetes, diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, delayed wound healing, insulin resistance, hyperglycemia, hyperinsulinemia, elevated blood levels of fatty acids or glycerol, hyperlipidemia, dyslipidemia, obesity, hypertriglyceridemia, Syndrome X, diabetic complications, atherosclerosis or hypertension, or for use in increasing high density lipoprotein levels in a mammal] "
• "In accordance with claim 1, this crystalline solvate is referred to as form SC-3 below. "
• D1 is the CPA.
• "D1 describes the stepwise synthesis of dapagliflozin." 
• "The appellant put forward inventive-step objections starting from both forms of dapagliflozin disclosed in D1, i.e. amorphous dapagliflozin and the crystalline complex of dapagliflozin with L-phenylalanine."
• "It can be concluded that form SC-3 has a higher stability, i.e. a lower hygroscopicity, than amorphous dapagliflozin."
• " the objective technical problem can be considered that of providing a pharmaceutical composition comprising a crystalline form of dapagliflozin which is more stable, i.e. less hygroscopic."
• "As regards obviousness, the appellant pointed to D4."
  
• "D4 relates to PG solvates of APIs and states, quite generally, (on page 4, paragraph 4; page 3, paragraphs 2 and 3) that: (a) the formation of PG solvates makes it possible to obtain crystalline compounds from APIs [active pharmaceutical ingredient] which are difficult to crystallise (b) API PG solvates are more stable and less hygroscopic than the corresponding APIs"
• The Board: "the skilled person, in order to take the teaching of D4 into account, would also have had to have a reasonable expectation of success, i.e. a reasonable expectation that this teaching would solve the objective technical problem. However, this is not the case, as set out in the following."
• "On pages 45 to 296, D4 gives a very long list of APIs whose PG solvates are said to be covered by the invention in D4. Among these compounds is T-1095 (page 267, entry 4), i.e. a compound which is structurally similar to dapagliflozin. In view of points 12.1 (a) and (b) above, this list amounts to D4 pretending to have found an almost universal solution to the problem of providing a crystalline form of an API and in particular to the problem of providing a form of an API which is less hygroscopic. This alone would not have given the skilled person a reasonable expectation of success, i.e. a reasonable expectation of obtaining a crystalline form of the compound dapagliflozin which is less hygroscopic than amorphous dapagliflozin. The reason is that, as agreed by both parties at the oral proceedings, the formation of crystalline forms and their properties such as hygroscopicity is highly unpredictable. So while the board acknowledges that D4 demonstrates that four structurally very different and unrelated APIs can be transformed into crystalline PG solvates, D4 lacks experimental data showing that an API PG solvate is less hygroscopic than the API itself."
• "Furthermore, the examples in D4 cast legitimate doubt on whether the effect of a lower hygroscopicity is actually achieved as universally as suggested. "[follows an analysis of the examples]
• " the skilled person would have considered the effect suggested by D4, namely the universal decrease in hygroscopicity, to be a mere allegation. Given the generally recognised high unpredictability of properties of crystalline forms (see above), the skilled person would not have had a reasonable expectation of obtaining a less hygroscopic form of dapagliflozin."
• " In summary, the subject-matter of claim 1 involves an inventive step over amorphous dapagliflozin as disclosed in D1 in combination with D4 because the skilled person, considering the teaching of D4, would not have had a reasonable expectation of obtaining a form of dapagliflozin which is less hygroscopic than amorphous dapagliflozin."
• The patent is maintained in amended form. 
• I use the term 'plausibility' in the blog post title as a generic catchword. The Board does not use it. Possibly, still, the 'technical teaching' requirement of G 2/21, or the credible requirement for second medical use claims in the same decision, can also be operationalized along the lines of this decision: would the skilled person have a reasonable expectation of success on the basis of the application as filed and using common general knowledge at the relevant date?

EPO 

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

T 0749/19 - Appeal fee reimbursement

Key points

• Rule 103 EPC is a gift that keeps giving (for text book authors).
• This time: the opponent gets a 25% refund of the appeal fee without withdrawing its request for oral proceedings and without withdrawing its appeal.
•  "The proprietor's indication that it would take no active part in the appeal proceedings, implies that the proprietor withdrew its request for oral proceedings "
• "in view of the conclusion that the patent must be revoked, the condition for the opponent's auxiliary request for oral proceedings does not arise."
• "Consequently, this decision is being issued on the basis of the parties' written submissions."
• "Both conditions of Rule 103(4)(c) EPC, that "any request for oral proceedings is withdrawn ..." and "no oral proceedings take place", are met"
• "It makes not difference that the withdrawing party and the appealing party are not the same (T488/18, reason 8)."
• The Board here seems to interpret "any request for oral proceedings"  as "at least one party withdraws its request for oral proceedings".
• The Board does not comment on T777/15 and T795/19, which came to the opposite conclusion, i.e. that the appellant must timely withdraw its own request for oral proceedings to obtain the partial reimbursement.
• " It also makes no difference that the withdrawal of the proprietor's request for oral proceedings was made prior to a "notification of the communication issued by the Board in preparation for the oral proceedings", or even of a summons. The Board shares the opinion expressed in T2361/18 at points 3.2 and 3.3, that the "within one month" of Rule 103(4)(c) EPC, rather than defining a time period starting with the notification of the communication, defines an "end point" for the withdrawal of the request for oral proceedings, if partial reimbursement of the appeal fee is to be obtained."
• "Consequently, the opponent's appeal fee is to be reimbursed at 25%."
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EPO 

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

T 0435/20 - Admissibility rules for OD

Key points

• This decision contains a number of important points regarding the admissibility rules for procedures before the OD.
•  "The board considers that the opposition division decided according to the wrong principles and disregarded the principles of procedural fairness and of equal treatment of the parties in not admitting documents D59 to D62 and D81 to D90. The reasons are as follows."
• The OD had also held evidence inadmissible submitted by the opponents on a point where the preliminary opinion of the OD was in their favour. The Board:   "the mere fact that the opposition division's preliminary opinion was positive for one party cannot in itself justify not admitting any further documents by this party which are filed by the final date set by the opposition division for making written submission under Rule 116(1) EPC. " (emphasis added)
• "the fact that the opposition division's preliminary opinion was negative for the appellant but positive for the respondents cannot justify a different treatment of the parties, since a preliminary opinion is neither binding nor definitive."
• The opponents filed a declaration D81 to support an earlier argument. The held the declartion, with annexes, inadmissible on the grounds iner alia that "the arguments of the declaration ... (D81) ... are reflected in the representative's arguments in the [accompanying] letter" 
• The Board: "arguments submitted by a party's professional representative do not qualify as means of giving evidence under Article 117(1) EPC and may therefore have a different weight depending on whether or not they are supported by evidence in the form of a declaration by a technical expert accompanied by evidentiary documents supporting the content of the declaration. Accordingly, the opposition division was mistaken in holding that the declaration D81 with supporting documents on the one hand, and the representative's arguments on the other were equivalent and that this could justify non-admittance of [declaration D81].
• The opponents had filed post-published evidence under sufficiency, which was held inadmissible on that ground by the OD. The Board: " consideration of a document submitted in substantiation of an allegation of fact does not depend on whether or not the document forms part of the state of the art (see CLBA, section III.G.4.1). The board therefore does not agree with the opposition division that, as a matter of principle, post-published evidence is prima facie unsuitable for the substantiation of allegations of verifiable facts in the context of sufficiency of disclosure."
• I note that the OD reasoned that: "documents D82 to D90 "were published years after the priority date of the present application and are prima facie not suitable to establish the general knowledge and the skills of the skilled person required at the date of filing which is discussed in this declaration". 
• The OD also violated the "principles of procedural fairness and of equal treatment of parties": "as noted above, documents D81 to D90 had been filed as direct and immediate response to new evidence, submitted by the appellant on the last day for making written submissions under Rule 116 EPC. In admitting the late filed documents D80 and its supporting documents D64 to D79 into the proceedings but not admitting documents D81 to D90 filed by the respondents in direct response, the opposition division did not respect the principles of procedural fairness and of equal treatment of parties."
• "Furthermore, prima facie relevance is to be assessed with taking into account the outcome of the proceedings (see CLBA, IV.C.4.5.3) and the opposition division gave no reasons why this criterion was not fulfilled for documents D59 to D62 [filed by the opponents]. Accordingly, the board cannot assess whether the opposition division has exercised its discretion in this respect correctly."
• The OD decided to revoke the patent, so this remark is not clear to me.
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EPO 

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

T 0116/20 - Inventive printed matter

Key points

•  Claim 1 is directed to a "venous access port assembly" with a radiopaque markings that comprises the letters "CT", in claim 10 these markings are printed on the surface.
• " the access port includes radiopaque markings (60) applied to a surface of the housing base (28), which include indicia (70) that comprise the letters "CT"."
• "Being radiopaque, these markings can be discerned on an X-ray and thereby provide information about the nature or characteristics of the access port assembly once it has been implanted in the patient."
• " D1 does not directly and unambiguously disclose at least radiopaque indicia that comprise the letters "CT"."
• I understand that D1 discloses radiopaque indicia.
• As to inventive step:  "the letters "CT" have no mirror symmetry. As explained in paragraph [0004] of the contested patent, these letters could, for example, be applied in a mirror-image orientation to the outwardly facing bottom surface of the port housing. In this case, they would appear right-side up on an X-ray when the port is viewed from above, and, conversely, mirror-inverted when the port is viewed from below. Due to the lack of mirror symmetry, the way the letters "CT" appear on an X-ray is uniquely correlated with the orientation of the port."
• " the objective technical problem starting from D1 [is] to enable a practitioner X-raying an implanted port to unambiguously determine the orientation of the port, including whether the port is being viewed from above or below."
• " D1 does not address the technical problem of determining the port orientation. It only discloses the alphanumeric message as having the purpose of identifying the port type []. Thus, in the absence of any teaching or suggestion in D1 that the message could be used to provide information about the port orientation, the person skilled in the art starting from D1 would have no motivation, even using their common general knowledge, to specifically select the alphanumeric message so that it has no mirror symmetry, let alone so that it specifically comprises the letters "CT"."
• As a comment, this decision illustrates that features defining presentations of information can contribute to inventive step namely if they have a technical effect.

EPO 

The link to the decision is provided after the jump.

T 1589/21 - Mentioned but not disclosed

Key points

•  This case reminds me of T 2842/18 where a verbatim statement was no valid basis for a claim amendment under Art. 123(2) EPC in a case about a second medical use claim.
• "One of the issues with respect to the amendments [under Article 123(2) EPC] was whether or not the application and the earlier application disclosed the purpose recited in the claim, i.e. protection against Lawsonia intracellularis, Mhyo and Porcine circo virus (PCV), in combination with the claimed vaccine and the administration route and scheme recited in the claim (intramuscular administration of the vaccine only once)."
• "Example 3 is the only passage in the application that discloses the administration of a composition of the three non-live antigens of the pathogens Lawsonia intracellularis, Mhyo and PCV as defined in the claim to subjects (pigs) intramuscularly and only once. However, as also disclosed in Example 3, after a single intramuscular injection, no Mhyo antibodies could be detected "
• "The information conveyed to the skilled person by Example 3 of the application is that the claimed vaccine does not confer protection against Mhyo when administered intramuscularly only once, yet the contrary is claimed, i.e. that it does confer such protection (see section I.). The claimed subject-matter hence relates to new technical information which is not directly and unambiguously derivable from the application."
  
• "The opposition division held that achieving the purpose recited in the claim was only a matter of sufficiency of disclosure, not of added subject-matter. In line with decision T 2593/11 (Reasons 3.4), it was sufficient that the inventors had "thought of" protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the claimed vaccine only once. This was evident from the purpose of Example 3 described in lines 2 to 4 of page 14 of the application and from the vaccination experiment carried out for Group 2 of Example 3 "
• "the purpose of Example 3 was "to test" a combination vaccine comprising killed whole cells of Lawsonia intracellularis and antigens of Mhyo and PCV. However, a mere statement that a vaccine test experiment was conducted, without disclosing any results, does not amount to a disclosure of the tested vaccine for a specific therapeutic purpose"
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•  "The board considers that this conclusion is in line with the established case law on novelty of second medical use claims. By way of example, mere statements that a particular therapy is being explored do not amount to a novelty-destroying disclosure of a second medical use claim which includes the achievement of this therapy as a technical feature (T 1859/08, Reasons 13), and a document that describes the administration of a compound to diseased subjects but neither explicitly nor implicitly discloses an effective treatment of the disease by this compound does not directly and unambiguously disclose this treatment (T 239/16, Reasons 5.2 and 5.3). Although this case law is on novelty and not on added subject-matter, the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (G 2/10, OJ EPO 2012, 376, Reasons 4.6, citing G 1/03, OJ EPO 2004, 413, Reasons 2.2.2)."
• "In line with this case law, the disclosure in the application that pigs were vaccinated with a combination vaccine comprising antigens of the three pathogens by intramuscular administration of the vaccine only once does not per se amount to a disclosure of protection against these three pathogens by this vaccine via this administration route and scheme. Moreover, as set out above (see point 9.), Example 3 in fact discloses that no protection against Mhyo could be obtained by an intramuscular administration of the combination vaccine only once. Therefore, Example 3 of the application does not directly and unambiguously disclose a vaccine comprising in combination non-live antigens of Lawsonia intracellularis, Mhyo and PCV for use in protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the vaccine only once."
  
  
• As a comment, this approach appears to merge, in a way, the requirements of sufficiency of disclosure and basis under Art. 123(2) (as is, incidentally, the case with the USA written description/enablement/possession case law).

EPO 

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