06 October 2023
This decision relates to an unusual case of added matter and how considerations typically relevant to sufficiency of disclosure impacted its assessment.
In this case, basis for an amended claim deriving (only) from an example was considered to be undermined by the apparent failure of the medical treatment described in the example to achieve the technical effect required by the main claim. In short, a second medical use claim cannot find basis in an example which does not successfully achieve the therapeutic effect set out in the claims.
The claim in question included the following features:
Example 3 of the application as filed included, amongst other things, two groups of animal subjects (piglets) which were injected intramuscularly with the triple vaccine combination product of Claim 1. One group was injected only once – as per the dosage regimen of Claim 1 – and another group was injected with a booster shot, thus receiving two doses of the combination vaccine and therefore falling outside of the dosage regimen of Claim 1. The example reported that a detectable level of antibodies for Mycoplasma hyopneumoniae was present only in the booster shot group and not in the single dose group (nor in a control group receiving no vaccine). Example 3 thus made clear that the single administration of the vaccine, as claimed, was not successful.
The patent in question was initially opposed on the grounds of added matter (Art. 123(2) EPC) and sufficiency of disclosure (Art 83 EPC) and was revoked at first instance for failing to meet the requirements of sufficiency of disclosure only. 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” (see T 2593/11, Reasons 3.4).
However, during the appeal against this decision by the proprietor, the Board of Appeal took the view that the technical feature of protection against all three pathogens using the claimed (single administration) dosage regime was not in fact adequately disclosed in the application as filed. At the hearing, the Board considered added matter (Article 123(2) EPC) first and ultimately revoked the patent on that ground without needing to consider sufficiency of disclosure, in contrast with the first instance proceedings.
Whilst it may seem strange for the particular result of an example to be decisive in whether or not a claim to a medical use can be considered to have basis in the application as filed, the Board’s decision makes more sense in light of established case law on novelty of second medical use claims.
“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).
“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 these earlier decisions relate to novelty, the Board held the view that “the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (in view of G 2/10, G 1/03).” In other words, a disclosure that would not be enabling in the sense of novelty, would also not be able to provide basis for an amendment.
When these decisions are considered, it seems clear that an example lacking any positive results cannot, in and of itself, be considered to disclose a medical use, where a positive outcome or improvement/benefit is normally considered implicit in a claim to the treatment or prevention of a disease or condition. This is clearly the case even if the intent or purpose of the example was to evidence that particular claimed treatment.
Nevertheless, it is clear that this decision applies only to the scenario where the example alone is being assessed for basis and not alongside other disclosures in the specification as filed which might normally be expected to be present. As many readers will know, using a specific example as basis for an amendment to a claim under European Patent Office (EPO) practice can often fall foul of added matter issues, particularly when only certain features are extracted (‘cherry picked’) from the example and imported into a claim and other features are left behind (as in the case of an ‘intermediate generalisation’).
In this particular case, the Board could seemingly have further justified the finding of added matter on the basis that there is an inextricable link in Example 3 of the claimed (single administration) dosage regime and a failure to inoculate against Mycoplasma hyopneumoniae. Importing the dosage regime from the example, without also the failed result reported therein, could therefore also be characterised as an unallowable intermediate generalisation under EPO practice.
This decision reaffirms the importance of providing disclosure of technical effects in the description, and not just confining them to discussion in the context of a specific example, in order for such disclosures to potentially serve as basis for a claim amendment under EPO practice. It also potentially adds further to an opponent’s toolkit in objecting to scenarios in which a claimed technical effect is based only on disclosures taken from examples, particularly where there is any ambiguity over the results achieved in those examples.
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