What to expect from EPO oppositions and how to stay in control
Decisions taken shortly after grant can determine what arguments, evidence, and claim requests remain available years later, including on…
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The European Patent Office applies a particularly strict approach when assessing the allowability of amendments under Article 123(2) EPC. According to the Enlarged Board of Appeal decision G 2/10, the “gold standard” test for determining the allowability of an amendment is whether a skilled person would directly and unambiguously derive the disclosure from the application as filed.
Where a claim is amended by incorporating a feature selected from a single list of alternatives, such an amendment will normally comply with Article 123(2) EPC. The assessment of allowability becomes more complex, however, where features are combined from two or more lists.
This increased complexity arises because the content of an application cannot be treated as a “reservoir” from which isolated features can be arbitrarily extracted and combined to create an altogether new embodiment. For a combination of features from multiple lists to be allowable, the application as filed must contain a pointer to that particular combination of features, such that the skilled person would directly and unambiguously derive the combination as the preferred embodiment of the invention.
The case law concerning the “selection from lists” was considered in a recent EPO Technical Boards of Appeal decision, T 1462/24, in which the proprietor of the patent raised the question of whether, “for the assessment of compliance with Article 123(2) EPC, do selections of features from two lists ‘of some length’ necessarily lead to added subject matter?”.
The case relates to European patent no. 265387 and focused on the independent claim:
“Dimethyl fumarate or monomethyl fumarate for use in treating multiple sclerosis, wherein the dimethyl fumarate or monomethyl fumarate is to be orally administered to a subject in need of treatment for multiple sclerosis at a dose of 480 mg per day.”
Following the patent’s grant, 14 separate oppositions were filed. The Opposition Division ultimately decided to maintain the patent in amended form on the basis of auxiliary request 12. Both the proprietor and the opponents appealed the Opposition Division’s decision.
In their submissions, the proprietor argued that the combination of the following features:
is directly and unambiguously derivable from the application as filed. In contrast, the opponents contended that the specific combination is not directly and unambiguously disclosed in the application as filed.
Moreover, the proprietor submitted that because the “gold standard” test does not require the combined features to be disclosed in a single passage, arguments based on the “selection from lists” approach are in contradiction with the “gold standard” test.
However, the opponents did not rely on a “selection from lists” argument, instead arguing that the application as filed does not disclose any explicit or implicit link between the treatment of MS and the specific dosage of 480 mg per day.
In reaching its decision, the Board agreed with the proprietor that, where features are originally disclosed separately, their combination may nevertheless be directly and unambiguously derivable from the application as filed, provided that the application contains explicit or implicit pointers to their specific combination. However, the Board rejected the proprietor’s contention that a 480 mg per day dosage is implied as the preferred embodiment in the application.
The application discloses a list of alternative dosage options for DMF/MMF, and this list converges to a dosage of “about 720 mg per day”. The Board therefore found that the application implicitly identifies 720 mg per day as the preferred embodiment of the invention.
Further, the Board agreed with the opponents that the paragraph relating to DMF/MMF dosage would be understood by the skilled person as being of a general nature, and not as being specifically linked to the medical treatment of MS.
As a result, the Board concluded that the application as filed does not directly and unambiguously disclose the combination of a 480 mg per day DMF/MMF dosage and its use in treatment of MS. As such, the subject matter of the proprietor’s main request and auxiliary requests was found to extend beyond the content of the application as filed, contrary to Article 123(2) EPC, and the patent was revoked.
In response to the proprietor’s question concerning the “selection from lists” approach, the Board held that “selections from lists” do not necessarily result in added matter.
Rather, a finding of added matter depends on whether the combined features are disclosed in the application as filed in groups of ‘equally applicable alternatives’, and whether the application contains pointers to the preferred combination of features. This assessment must be carried out on a case-by-case basis. In this way, the “selection from lists” approach examines whether the particular combination of features are merely conceptually disclosed, or whether the selected features are individually disclosed in combination in the application as filed. Accordingly, the Board confirmed that the “selection from lists” approach is consistent with, and complementary to, the “gold standard” disclosure test.
For applicants, T 1462/24 underlines the importance of explicitly disclosing intended combinations of features at the drafting stage, particularly where it is foreseeable that specific combinations may later need to be relied upon during examination. In summary, amending a claim by selecting features from multiple lists found in the application as filed does not automatically lead to a finding of added matter. However, such an amendment will only be allowable if the application as filed contains explicit or implicit pointers to the specific combination of those features as representing a preferred embodiment of the invention.
If you would like advice regarding ‘selections from lists’ or for any other intellectual property query, please get in touch to speak to one of our attorneys.