11 May 2021

A round-up of recent decisions from the boards of appeal at the EPO

Whilst a recent referral to the Enlarged Board of Appeal in T 1807/15, questioning the legality of holding Board of Appeal oral proceedings by videoconference without the consent of all parties, has the potential to disrupt future appeal proceedings during this pandemic, there are still plenty of decisions to consider for now. Here, we take a look at some of the decisions from the technical and legal Boards of Appeal.

1) T0944/15 – Can computer programs be excluded as surgical/diagnostic methods for treatment under Article 53(c) EPC?

It is well-established that claims to methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patentability under Article 53(c) EPC. However, it is equally well-established that this exclusion does not apply to products for use in these methods. The question of how to apply these provisions to a claim directed to a computer program which, when running on a computer, causes the computer to perform an excluded method was considered in T 0944/15.

In a decision that will be surprising to some, the Board of Appeal came to the conclusion that such a computer program can be excluded under Article 53(c) EPC. In reaching this decision, the Board of Appeal directly contradicted the EPO’s Guidelines for Examination, G-II, 4.2.1, which explicitly state that such computer programs “are not to be objected to under Art. 53(c) EPC”. As such, this seems to be a controversial decision and it may well not be the last we hear on this point.

2) T0799/16 – The bar for sufficiently disclosed and inventive second medical use dosage regimes

For a claim directed to a second/further medical use of a compound or composition to satisfy Article 83 EPC (sufficiency of disclosure), it must be credible that the compound or composition shows therapeutic efficacy in the claimed patient population. In T0799/16, the Board of Appeal considered arguments that the applicant’s data demonstrated that only a sub-population of patients with multiple sclerosis (MS) would respond to a claimed treatment (not MS patients in general, as recited in the claims in question) and therefore whether the claimed treatment was sufficiently disclosed. The Board acknowledged that the data showed that a population of non-responders existed (only about one third of the patient population tested responded to the claimed treatment). However, it was reasoned that the existence of non-responders is not a reason to deny sufficiency of disclosure (groups of non-responders are common in many treatment areas) and further that the non-responders do not have to be excluded from the claims.

The Board stated “If it can be shown that a relevant proportion of patients benefits from a treatment and that it has acceptable safety, the criterion of sufficiency of disclosure is met, since the person skilled in the art has the necessary technical information to perform the treatment”. What constitutes “a relevant proportion” will depend on the facts of the case. However, it appears that the bar may be lower for therapeutic indications that are particularly difficult to demonstrate efficacy in.

Not only did the Board find the claims in question to be sufficiently disclosed, it also deemed the claims inventive by virtue of the claimed dosage regime (10 mg bid). This was even in light of prior art that described the same 10 mg bid dosage regime. In the Board’s opinion, the prior art did not explicitly state that the dosage regime resulted in the claimed efficacy (increasing the walking speed of MS patients) and, due to the extreme difficulty in demonstrating said claimed efficacy, the person skilled in the art would have failed to appreciate the utility of the 10 mg bid dosage regime in the prior art. In fact, a new statistical method was required to demonstrate the claimed efficacy. Whether this method would have been obvious to the skilled person was not addressed and in absence of this discussion, the Board decided that the efficacy associated with the claimed dosage regime was not obvious based on the available prior art.

3) T0265/20 – The importance of checking the text intended for grant

T0265/20 is unusual in that it was an appeal against a decision to grant a patent. The appellant’s issue with this decision was that the granted patent was missing all of the drawings. It transpired that this was caused by the accidental omission of the drawings from the text intended for grant when the Rule 71(3) EPC communication was issued, an omission that was not noticed by the applicant when reviewing this text. Unfortunately for the appellant, the Board of Appeal could not be persuaded that there was any legal basis for the allowance of an appeal rectifying this. In particular, the Board argued that “the “true will” of the members of the examining division when editing the communication pursuant to Rule 71(3) EPC is of no relevance.” This case stands as a useful reminder of the importance of a detailed review of the text intended for grant. Many errors concerning the contents of the patent, even when made by the EPO, cannot be fixed after grant.

4) J0010/20 – Legal justification for the EPO’s COVID-19 extensions

At the beginning of the pandemic, the EPO issued a notice (OJ EPO 2020, A29) announcing the extension of all deadlines. The EPO justified the extension by referring to disruptions due to the COVID-19 outbreak, stating that there was a general dislocation in Germany, and indicating that this was in accordance with Rule 134(2) EPC. Through subsequent notices, this turned into a substantial extension of deadlines, only ending months later in June 2020.

Despite not appearing entirely convinced that these COVID-19 extensions necessarily had legal basis within the meaning of Rule 134(2) EPC, the Board of Appeal in J 0010/20 ensured that the announced extensions could be relied on by instead focusing its analysis on the principle of legitimate expectations. In particular, the Board noted that it did not need to decide whether the COVID-19 extensions had legal basis, because the notices issued by the EPO amounted to a source of legitimate expectation that the appellant was entitled to rely on in any case.

5) T0552/14 – Avoiding the concept of ‘technical novelty’

The question of ‘technical novelty’ (the concept that only technical features can provide novelty) occasionally arises at the EPO, and there have been indications from the Boards of Appeal that it may well be the case that only technical features can provide novelty. However, the Boards have generally appeared reluctant to make any definitive decision on this point, tending to find other grounds for making their decisions on specific cases.In the decision leading to the appeal of T0552/14, however, the examining division was clearly of the view that these indications from the Boards of Appeal were sufficient to establish the existence of ‘technical novelty’. As such, citing G2/88, T0172/03 and T0154/04 as support for its approach, the examining division took into account only technical claimed features in its assessment of novelty, and thus refused the application as lacking novelty.

In considering this on appeal, and perhaps not unexpectedly, the Board of Appeal avoided making a decision on the existence of ‘technical novelty’, by instead considering inventive step. Interestingly, the Board did not appear to provide any specific indication as to whether the examining division was right or wrong to refuse the application as lacking novelty on the basis of a ‘technical novelty’ analysis, but instead explained that it did not need to decide on this issue because there was a lack of inventive step in any case.

Given the ease of the way in which non-technical features can be disregarded in the assessment of inventive step, rendering the issue of ‘technical novelty’ moot, we may be waiting a long time for any definitive decision on the existence of technical novelty.

6) T2015/20 – Sufficiency, inventive step and speculation

In T2015/20 the Board of Appeal considered whether a second medical use claim reciting a dosage regime satisfies the requirements of sufficiency of disclosure and inventive step. Interestingly, the Board took the opportunity to state that the EPO’s approach to sufficiency and inventive step has been developed to take account of the technical contribution actually disclosed in a patent application and to avoid patent protection resulting from unreasonable speculation. Some speculation is of course allowed (even in the field of medicine) but propositions that are prima facie implausible should not be.

In the present case, the Board noted that sufficiency of disclosure cannot be acknowledged if an invention goes against a prevailing technical opinion and the patent fails to give even a single reproducible example. In the application in question, the claims related to aclidinium for use in the treatment of asthma, whereas the examples in the application demonstrated effectiveness only in treating chronic obstructive pulmonary disease (COPD). However, the Board reasoned that the description of the application stated that aclidinium could be used to treat asthma and that the prior art did not teach against this effect (instead it corroborated the effect). As such, the claimed invention did not go against the prevailing technical opinion and the claimed invention was therefore sufficiently disclosed.

The Board also considered whether the claimed invention (optimised dosage of aclidinium for treating asthma) was inventive. The Board’s reasoning relied on its assumption that an optimised dosage for treating COPD also represented an optimised dosage for treating asthma. Prior art data relating to the use of aclidinium in the treatment of COPD was therefore considered but found to teach away from the claimed optimised dosage regime which was thus found to be inventive.