EP 2 187 879 B1 relates to a pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative, and is parent of two divisional applications, both deemed withdrawn.
Brief outline of the case
The opposition was rejected and all four opponents appealed.
The board decided revocation of the patent for lack of IS over D2=WO 2005/092 867 as CPA.
The case is interesting as it deals with the interpretation of G 2/21, and T 116/18 which led to and followed the referral.
The proprietor suggested to refer a series of questions to the EBA. This request was rejected by the board.
The opponents’ point of view
D2 constituted a suitable starting point for the assessment of inventive step of the claimed subject-matter. This document disclosed combinations of SGLT2 inhibitors, in particular empagliflozin, with DPP IV inhibitors such as vildagliptin and sitagliptin for use in the treatment of diabetic conditions.
The subject-matter of claim 1 differed from this disclosure in terms of the DPP IV inhibitor, i.e. linagliptin.
No technical effect could be assigned to this difference. The two technical effects identified by the proprietor in this regard, i.e. an improvement in HbA1c and an increase in GLP-1 levels, should be disregarded when formulating the objective technical problem.
The evidence relied on by the proprietor for the alleged improvement in HbA1c lacked comparison with the CPA.
The purported increase in GLP-1 levels allegedly shown in post-published documents was not derivable for the skilled person from the technical teaching of the application documents as required by G 2/21.
The OTP was thus to provide an alternative combination of the SGLT2 inhibitor empagliflozin with a DPP IV inhibitor.
The solution proposed in claim 1 would have been obvious having regard to D3=WO 2004/018468, cited in the patent, which disclosed linagliptin as a suitable combination partner for SGLT2 inhibitors.
Contrary to the proprietor’s position, D3 did not need to provide a pointer to linagliptin that rendered the claimed solution obvious. In the absence of any technical effect linked to the distinguishing feature, the claimed solution merely represented one of a number of obvious alternative combinations at the skilled person’s disposal. Choosing between such alternatives did not involve an inventive step.
The proprietors point of view
The subject-matter of claim 1 differed from the CPA, i.e. document D2’s generic disclosure of a combination of a glucopyranosyl-substituted benzene derivative of formula I acting as an SGLT2 inhibitor with a DPP IV inhibitor, in that the glucopyranosyl-substituted benzene derivative was empagliflozin and in that the DPP IV inhibitor was linagliptin.
The technical effects linked to these differences were an improvement in HBA1c and an increase in GLP-1 levels, as shown in post-published documents D13, D55 and D56. With regard to the increase in GLP-1 levels, the criteria set out in point II of the order of G 2/21 were met.
Accordingly, the OTP was to “provide an improvement in HbA1c and an increase in GLP-1 levels“.
The solution proposed in claim 1 would not have been obvious having regard to the state of the art.
Even if the OTP formulated by the opponents were accepted, the skilled person would not have combined D2 with D3 in the first place.
Had the skilled person nonetheless considered such a combination, they would not have arrived at the claimed solution because documents D2 and D3 lacked any pointer towards empagliflozin as an SGLT2 inhibitor and linagliptin as a DPP IV inhibitor, respectively.
The board’s decision
The board disagreed with the OTP defined by the proprietor as being “an improvement in HbA1c and an increase in GLP-1”.
Alleged improvement in HbA1c
To support the purported improvement in HbA1c, the proprietor relied on post-published document D13.
For the board, the higher HbA1c reduction over the one observed in D13 is not suitable to show the alleged HbA1c improvement over the CPA.
The alleged HBA1c improvement could therefore not be taken into account for formulating the OTP.
Alleged “increase in GLP-1 level”
In support of the alleged “increase in GLP-1”, the proprietor referred to post-published documents D55 and D56.
At the OP, there was no dispute that the aforementioned findings in D55 on linagliptin as the sole active agent and empagliflozin as the sole active agent form part of the skilled person’s common general knowledge at the filing date of the patent. It was furthermore undisputed that document D55 did not include any experimental data providing a comparison with the CPA.
D56 discloses the results of a study in diabetic rats dosed “q.d. daily” from day 0 to day 5 with either linagliptin, empagliflozin, empagliflozin and linagliptin, empagliflozin and the DPP IV inhibitor sitagliptin, empagliflozin and the DPP IV inhibitor vildagliptin or vehicle.
The challenges in interpreting point II of the order of decision G 2/21
The board identified three challenges in interpreting point II of the order of decision G 2/21.
First, the requirements “encompassed by the technical teaching” and “embodied by the same originally disclosed invention” were not used in the plausibility case law underlying questions 2 or 3 of the referral.
Therefore, their relation to this case law remains to be defined, particularly in terms of whether, and to what extent, they replace, align with, or modify it.
Second, the EBA did not expressly define these requirements. It could be argued that the dependent clause “because such an effect does not change the nature of the claimed invention” in point 93 of decision G 2/21 serves as their definition.
Finally, the EBA did not expressly state the purpose of these requirements.
Analysis/interpretation of T 116/18 following G 2/21
For requirement (i) of order II to be met, the purported technical effect together with the claimed subject-matter need only be conceptually comprised by the broadest technical teaching of the application as filed. This means that said effect need not be literally disclosed in it, but is necessarily relevant to the claimed subject-matter.
As far as requirement (ii) is concerned, the question to be asked can be formulated as follows: would the skilled person, having the common general knowledge on the filing date in mind, and based on the application as filed, have legitimate reason to doubt that the purported technical effect can be achieved with the claimed subject-matter?
Requirement (ii) is met unless the above question is to be answered in the affirmative. For this, there is no reason to look for a positive verbal statement about the effect in the application as filed. This would be far too near the conditions of the gold-standard in G 2/10. Such an understanding could not have been the EBA’s intention in G 2/21.
The present board faced two issues with the interpretation of G 2/21 given in T 116/18.
On the one hand, the referring board stated in T 116/18, that in G 2/21 the EBA did not refer to any “plausibility” standards identified in the referring decision.
On the other hand, when defining how to meet requirement (ii) in G 2/21, this same board stated that requirement (ii) of the order was met unless the skilled person, having the common general knowledge on the filing date in mind, and based on the application as filed, would have legitimate reason to doubt that the purported technical effect can be achieved with the claimed subject-matter.
In doing so, the board effectively adopted what it defined in the referral T 116/18 as the “ab initio implausibility” standard.
For the present board, some of the inferences drawn in T 116/18 were not supported by the text of decision G 2/21.
In T 116/18, the board concluded that the test to be applied in assessing whether the requirement (ii) of point II of the order of G 2/21 was met was the “ab initio implausibility” test. However, nowhere in G 2/21 did the EBA state that requirement (ii) of point II of the order was met, unless the person skilled in the art would have had legitimate reasons to doubt that the purported technical effect would have been achieved on the filing date.
In T 116/18, the board concluded that a positive verbal statement of the technical effect relied upon by the patent applicant or proprietor in the application as originally filed was not necessary for requirements (i) and (ii) had to be met. However, such a statement is also not to be found in G 2/21.
In T 116/18, the board gave two main reasons for its conclusion:
(i) the EBA did not state that the effect must be “directly and unambiguously derivable” but used less strict words, “derivable”/”derive”;
(ii) the terms “invention” and “technical teaching” meant the same in G 2/21, and both were to be understood as “the broadest technical teaching of the application as filed contained in it with regard to the claimed subject-matter”.
The first reason relates specifically to requirement (ii) and the second reason to requirement (i) of point II of G 2/21. However, neither was conclusive.
The use of the terminology “derive/derivable” in G 2/21, the order and the Reasons of G 2/21 use these words in a different context.
The order did not state that a patent applicant or proprietor may rely upon a technical effect for IS if the skilled person would derive such effect from the application as originally filed.
Instead, it states that a patent applicant or proprietor may rely upon a technical effect if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.
Therefore, it is not possible to infer from the verb “derive” in point II of the order of G 2/21 any specific meaning for the terms “embodied” or “encompassed“. This is so because the verb “derive” simply introduces the two requirements rather than defining them.
The board’s contention that the term “technical teaching” in requirement (i) has the same meaning as the term “same originally disclosed invention” in requirement (ii) and that both mean the “broadest technical teaching of the application as filed contained in it with regard to the claimed subject-matter”, led to the following observations by the present board:
it is not immediately clear how it can be concluded from this semantic equivalence and related definition that for requirement (i) to be met the purported technical effect together with the claimed subject-matter need only be “conceptually encompassed” by the broadest technical teaching and that this in turn means that “said effect need not be literally disclosed in it by way of a positive verbal statement”.
Therefore, the present board considered that the passages of G 2/21 referred to in T 116/18 do not lead to the conclusion that the standard of disclosure that applies to Art 87, referring to the concept of “same invention”, Art 123(2) or Art 54(1), cf. G 1/03, Reasons 2.2.2; decision G 2/10, Reasons 4.6, is excluded when assessing whether the technical effect on which the patent applicant or proprietor relies is
(i) encompassed by the technical teaching that the skilled person, with the common general knowledge in mind, would understand at the filing date from the application as originally filed “as the technical teaching of the claimed invention”, and
(ii) embodied by the same originally disclosed invention.
While this may be a valid approach, it does not follow from the text of G 2/21.
The Board’s approach in the case at hand
For the board, a skilled person would not expect the technical effect in question – an increase in active GLP-1 levels from the combination of empagliflozin and linagliptin compared to increases in active GLP-1 levels achieved with combinations of emplagliflozin with sitagliptin and vildagliptin, respectively – on the basis of the original disclosure of the application itself.
This effect is not only unsupported and not made credible by the application as originally filed; it even contradicts its technical teaching. Therefore, whatever the meaning of the two requirements in G 2/21 may mean, they cannot be met in the present case if patenting for inventions not made at the filing date is to be excluded.
On page 24, line 24 to page 27, line 14, the application as originally filed describes linagliptin as one of twelve preferred DPP IV inhibitors according to a first embodiment (embodiment “A”).
Regarding the second embodiment (embodiment B), preferred DPP IV inhibitors are selected from the group consisting of sitagliptin, vildagliptin, saxagliptin and alogliptin.”
The first of these two paragraphs does not single out the currently claimed combination of empagliflozin and linagliptin. Rather, it refers to combinations of the aforementioned twelve DPP IV inhibitors with other, not further defined pharmaceutically active substances.
The board has not been made aware of any text passage in the application as originally filed on the basis of which the skilled person would understand the term “structurally comparable DPP IV inhibitors” referred to in this first paragraph to include the DPP IV inhibitors sitagliptin, vildagliptin, saxagliptin and alogliptin, respectively.
On the contrary, the application as originally filed presents combinations of empagliflozin with linagliptin, sitagliptin, vildagliptin, saxagliptin or alogliptin at an equal level of preference.
The purported technical effect relied upon by the proprietor for inventive step is an increase in plasma levels of active GLP-1 which is stronger and more prolonged in time than the one achieved by combinations.
For the board, the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would not derive the increase in plasma levels of active GLP-1 relied on by the respondent as being encompassed by the technical teaching of the claimed invention and embodied by the same originally disclosed invention.
Comments
G 2/21 is one of the most controversial decisions of the EBA. It is not sure that by rendering the term “plausibility” taboo, it has really helped parties. After G 2/21 the term “credibility” has become fashionable instead. Where is the gain?
The decisions applying G 2/21 show a great diversity, as has been shown in the present blog.
The present board in attempting to interpret the two requirements in Point II of the order of G 2/21, found that the EBA had not expressly stated the purpose of these requirements. It also, albeit indirectly, criticised T 116/18 which followed G 2/21.
In the absence of a clear purpose of the two requirements (i) and (ii), the conclusion of G 2/21 by the present board could be summarised as follows: the effect on which the applicant/proprietor could rely to demonstrate IS should/would not change the nature of the claimed invention. This was also the conclusion in G 1/03 about undisclosed disclaimers.
The requirements set out in point II of the order of G 2/21 are such as to prevent an applicant/proprietor from relying on a technical effect which would change the nature of the claimed invention, and is intended as a safeguard to ensure that only inventions already made and disclosed at the filing date are granted patent protection.
One could infer that fulfilling the requirements of point II of the order in G 2/21 lies somewhere between standard of disclosure that applies to Art 87, Art 123(2) or Art 54(1) without necessarily requiring a direct and unambiguous disclosure of the effect. It is just enough that the effect can be “derived”.
Whatever the effect might be, it has to be demonstrated with respect of the CPA. Any comparison with prior art which is not the CPA, is not acceptable.
The present board used the notion of broadest technical teaching of the application and not of the claim. It is nevertheless thinkable, that the answers to G 1/24, might have an effect on the interpretation of G 2/21.
On the procedure
The CPA=D2=WO 2005/092 867 and D3=WO 2004/018468, were mentioned in the ISR established by the EPO as documents of category X which, on top, belong to the proprietor of the present patent and has inventors in common with the present patent. The conclusions of the board couldd have been reached by the ED or the OD.
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