EP 2 321 651 B1 relates to the identification of subjects being susceptible to anti-angiogenesis therapy.
Brief outline of the case
In a first decision the OD revoked the patent. As the OD committed a SPV, the case was remitted to the OD for further prosecution, cf. T 66/20.
In a second decision, the OD decided that claim 1 as granted lack IS over D8=C. D. Britten et al., Cancer Chemother Pharmacol 61, 2008, 515-524, not mentioned in the ISR established by the EPO. AR1-13 suffered the same defect. The patent was maintained according to AR14.
Claim 1 as granted reads as follows:
“1. A method for predicting the risk of an acute cardiovascular event and/or heart failure as a consequence of a future anti-angiogenesis-therapy with a VEGF-antagonist, comprising the steps of
a) determining the amount of a cardiac Troponin in a sample of a subject; and
b) comparing the amount of a cardiac Troponin as determined in step a) with reference amount for a cardiac Troponin,
wherein the risk of an acute cardiovascular event and/or heart failure of a future anti-angiogenesis therapy with a VEGF-antagonist is predicted for said subject.”
The proprietor appealed.
Neither the opponent nor the proprietor contributed in substance to the procedure.
The board decided that the claim as granted was inventive, but remitted to the OD for further prosecution, especially for checking if the invention was sufficiently disclosed.
The OD’s decision
The claimed method differed in that D8 does not disclose that the cTnT and/or cTnI levels measured before the treatment with sunitinib predicted the risk of an acute cardiovascular event and/or heart failure as a consequence of the future treatment with sunitinib.
The OTP to be solved by the claimed method was seen as the provision of a method for predicting the risk of an acute cardiovascular event and/or heart failure.
The OD was of the opinion that this problem was not credibly solved because “a skilled person faced with predicting the claimed risk would not be able to do so in the absence of a defined reference amount”.
The OD based its considerations on the facts that in the study described in document D8,
1) cTnT and cTnI levels were determined in patients prior to the treatment and only patients that had cTnT and cTnI levels <= ULN were selected for the treatment, a fact that implied that the significance of elevated values of cTnT and cTnI for cardiovascular toxicity was known, and that
2) patients who developed serum cTnT or cTnI levels above the ULN were required to discontinue sunitinib.
The board’s decision
The board noted that the claim comprises the feature “wherein the risk of an acute cardiovascular event and/or heart failure as a consequence of a future anti-angiogenesis-therapy with a VEGF-antagonist is predicted for said subject” and this is also the purpose of the claimed method, i.e. this effect is expressed in the claim.
For this reason alone, the question whether the claimed method achieves this effect cannot be a question of IS but of sufficiency. The bord referred to G 1/03, Reasons 2.5.2. The board saw no reason to deviate from the EBA on this issue.
Following on from G 1/03, it was thus evident that the OD erroneously reasoned to the extent that in its discussion of IS, it took into account considerations that belong to a discussion of sufficiency of disclosure. This has the consequence that the considerations set out by the OD in its decision under appeal are irrelevant under the provision of Art 56 and cannot demonstrate a lack of IS.
The OTP formulated by the OD and by the proprietor is thus, per definition, considered to be solved. This leaves the question to be reviewed by the board whether the solution claimed, namely a method as defined in the claim, was obvious over the disclosure in D8 alone.
In the study described in D8, patients were selected for the study based on several eligibility criteria including an “adequate cardiac function”, and it was in this context that, among other criteria, such as the absence of cardiovascular events and heart failure in the previous 12 months, cTnT and cTnI levels were assessed.
In the study described in D8, cTnT and/or cTnI levels were determined prior to the treatment with sunitinib in order to include only patients with normal cTnT and cTnI levels in the study.
This allows the evaluation of the safety and side effects, including cardiotoxicity, of the new drug administration protocol by assessing possible changes of, inter alia, these parameters by the treatment. No conclusion can be drawn from this on whether particular levels of these markers allowed to predict the risk of an acute cardiovascular event and/or heart failure as a consequence of the future treatment with sunitinib.
D8 teaches that elevated cTnT and/or cTnI levels are indicators of a current cardiac dysfunction and that they are possible side effects of a treatment with sunitinib. However, since D8 only assessed the side effects of sunitinib on patients with normal cardiac function, including normal cTnT and/or cTnI levels, the skilled person could not know or reasonably expect from this teaching whether initially elevated levels of cTnT and/or cTnI levels would predict a patient’s risk of an acute cardiovascular event or heart failure as a consequence of a future treatment with sunitinib.
In view of these considerations, the OD’s reasons as to why the claimed method was obvious in view of the disclosure in D8 cannot be followed.
No decision on sufficiency of disclosure was taken by the opposition division with respect to the MR.
Sufficiency of disclosure was only considered for former AR 12 in OD’s first decision. It is clear from this decision that objections on sufficiency of disclosure had been raised in the notice of opposition that are relevant for the current MR.
The case was therefore remitted to the OD.
Comments
Although G 1/03 related to undisclosed disclaimers, it also mention a link between the assessment of IS and sufficiency.
The interplay between Art 83, Art 84 and Art 56 is best exemplified in of T 2001/12 which can be summarised as follows:
If a technical effect is not claimed, and if it appears not credible that the invention as claimed would actually be capable of solving the problem, then the objection is an objection of lack of IS under Art 56.
If a technical effect is claimed, and if it appears not credible that the invention as claimed would actually be capable of solving the problem, then the objection is an objection of lack of sufficiency under Art 83.
If the question arises because the claim fails to specify those features which are disclosed in the application as providing the solution to the problem, then the description and claims are inconsistent in relation to the definition of the invention, and an objection under Art 84 may arise in that the claims do not contain all the essential features necessary to specify the invention.
Quite a few decisions cite T 2001/12, but in my experience this decision is largely unknown among practitioners.
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