EP 2 991 507 B1 relates to a composition comprising fish oil and juice in an oil-in-water emulsion for use in treatment (and post-treatment) of cancer.
Brief outline of the case
The patent was revoked and the proprietor appealed.
In response to the board’s communication under Art 15(1) RPBA, the proprietor withdrew all but AR 24 to 47.
The board admitted AR 24 (claims 1 and 2 as filed) as the post treatment of cancer had been deleted, and the number of cancers to be treated by the composition was significantly reduced.
The board decided maintenance according this AR with a description to be adapted.
The opponent’s point of view
The opponent argued that the claimed subject-matter did not meet the requirement of Art 83 since it was not plausibly demonstrated that the claimed therapeutic effects were achieved over the whole claimed range.
It argued that it had not been shown that any type of juice when used in combination with fish oil was suited to providing the claimed therapeutic effects. There was no guidance in the application as filed on which of these juices, when combined with fish oil, promoted anti-cancer effects
The skilled person did not have any information from the application as filed to render it plausible that the alleged effects were the result of using fish oil and juice only.
The opponent criticised the breadth of claim 1 with respect to the feature “juice“, which was broadly defined, and it submitted that it was not plausible that any juice was successful in treating the two types of cancer defined in claim 1.
The opponent presented two additional submissions that warranted consideration. First, it cited decision T 609/02 to bolster its challenge under Arti 83, claiming its findings should apply to the current case. Second, it argued that the “totox” value specified in claim 1 is meaningless. However, both submissions were found unconvincing. We will only look at the first one.
The board’s decision
For the board, there is clear guidance in the application as filed that juices from fruits or berries having a high level of antioxidants, preferably from fruits having a minimum level of metal ions functioning as oxidising agent, may be used in the claimed composition. A comprehensive list of suited juices was given, so a skilled person was provided with ample guidance on the juices which may be used in the claimed composition.
There was no evidence on file to support the opponent’s allegation that choosing any of these explicitly proposed juices might fail to achieve the claimed therapeutic effects. The opponent has not submitted any such evidence, for example, in the form of experimental data. In this context, the board disagreed with the statement given in the decision under appeal that a skilled person would not know which juice to choose.
For the board, it was credible from the information in the application as filed that the claimed combination of fish oil and juice leads to the claimed therapeutic effects (see G 2/21, Reasons 74).
T 609/02 was quoted in G 2/21 (see Reasons 75) and several other decisions of the boards. For therapeutic use claims, the boards have derived from T 609/02 the principle that for Art 83 to be complied with, the suitability for the claimed therapeutic use, unless already known to the skilled person at the priority date, must be disclosed in the application. The board referred to T 609/02, Reasons 9 and the Case Law of the Boards of Appeal, 10th ed. II.C.7.2.1).
The reference to this decision cannot, however, change the assessment made by the current board because the facts are different. In the case underlying T 609/02, there was no evidence in the patent (or the application as filed) that the alleged effect took place. Furthermore, the application was also silent on the identification of the compound allegedly providing the effect (Reasons 5).
The board also noted that in several decisions of the boards, it was stated that the facts underlying decision T 609/02 differed from the facts underlying the respective cases judged in these decisions, cf. T 117/04, Reasons 25; T 950/13, Reasons 3.9.1; T 2627/17, Reasons 2.1.3).
While it is true, as held in T 2059/13, that differences in facts on which decisions are based are normal and the usefulness of case law is not confined to similar or identical facts, see Reasons 4.2.3. Tthe current board was of the opinion that the facts underlying T 609/02 should be taken into account when considering its findings for its applicability to the case at hand.
The board came to the conclusion that the opposite was true in the current case. The patent, and the application as filed, contains examples of the therapeutic uses claimed. Additionally, the composition providing the effect is clearly identified. As a consequence, the board did not find that the invention was “made at a date later than the effective date of the patent”, cf. T 609/02, Reasons 8.
The board concluded that the rationale underlying T 609/02 is not at odds with the present board’s finding of compliance with Art 83.
Comments
Whilst the opponent spoke about plausibility, the board was careful not to use this word, but used instead credibility as seen in G 2/21.
It is also interesting to note that the usefulness of case law is not confined to similar or identical facts
Necessity of experimental data
The present decision shows once more that when it comes to sufficiency of disclosure it is difficult for an opponent in order to demonstrate lack of sufficiency not to present some experimental data. Mere theoretical objections are in general not sufficient.
Experimental data can be dispensed with
Mere theoretical objections are not sufficient, unless like in T 609/02, the description provides no more than a vague indication of a possible medical use for a chemical compound yet to be identified, and later more detailed evidence cannot be used to remedy the fundamental insufficiency of disclosure of such subject-matter. The way G 2/21 has been applied is however quite generous for applicants and proprietors.
Another case in which theoretical objections can be sufficient is when the invention is defined by parameters and there is no measurement method disclosed in the original application, or no known method is available to the skilled parson.
In opposition, some boards have considered that this is a question of clarity, cf. G 3/14, but it appears much more a problem of sufficiency.
An objection of lack of sufficiency cannot be overcome
It should not be forgotten that an objection of lack of sufficiency could only be overcome with added matter, that is it cannot be overcome, whilst a lack of clarity can be overcome when taking into account the description, even in opposition. If a method is disclosed in the description or known to the skilled person, the claim can be “virtually” amended, so as to virtually resolve the clarity problem.
In the absence of disclosure of measurement method in the original application, or when no known method is available to the skilled parson, it is too easy for the boards to deal the matter under clarity and in view of G 3/14 simply ignore the problem. .
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