European Examiners Clarify Approach to Second Medical Use Claims
During their visit to Cambridge Enterprise, the Examiners based in the pharma and chemistry directorates of the European Patent Office (EPO) explained how they examine claims directed to second and further medical use. They pointed out some common issues relating to clarity and sufficient disclosure and highlighted selection criteria conferring novelty to further medical use claims. We provide a summary of some of the key outcomes of this meeting below, and some tips on how to prepare pharma/chemical patent applications.
Second Medical Use
A claim to a second medical use is a claim to a product already used for one therapeutic application when it is used for another therapeutic application. It may take the form “Product X, for use in the treatment of disease Y”.
The EPO allows such claims because it considers the intended use of such a product to be a functional technical feature of the claim. Further medical use claims are also allowed when the novel therapeutic application is for a different disease (“Product X, for use in the treatment of disease Z”) or is based on a selection of a group of patients (T233/95), a mode of administration T51/93), a dosage regimen (G2/08) or a clinical situation (T406/06).
The Examiners pointed out that a second or further medical use claim requires a disclosure of the suitability of the product for the treatment of the disease. The disclosure must be plausible – a mere assertion that a product is suitable for treatment of a disease is not sufficient. In other words, the disclosure must provide information which shows that the product has a direct effect on the mechanism of the disease (T609/02). Such information does not require clinical trials data – but only in vitro experimental data showing a pharmaceutical effect which directly and unambiguously reflects the therapeutic application. It must form part of the application as filed – and cannot be used to back up an assertion of therapeutic effect following the filing.
The EPO considers a second medical use claim to lack clarity when it refers solely to a mechanism of action and the skilled person cannot recognise what medical conditions fall within the scope of the claim. A claim for a “Product X, for treating a condition which can be improved by selective occupation of a receptor 5HTIC” is, for example, objectionable because it may encompass any number of conditions (T241/05). A claim for a “Product X, for influencing tumour cell growth and differentiation” is however, allowable because it is clearly directed to the treatment of tumour and cancer (T836/01).
The Examiners indicated that selection in a group of patients confers novelty when the new group is parallel to the existing group – as is the case, for example, for non-haemophilic patients and haemophilic patients (T893/90). A selection in a group of patients which overlaps with an existing group confers novelty when the selected group can be distinguished over existing patients by their physiological or pathological status (T734/12). A claim characterised by selection in a group of patients which forms a sub-group of an existing group is novel and involves an inventive step only when there is an unexpected effect such as therapeutic activity in resistant groups, improved therapeutic activity or avoidance of adverse events (T108/09).
The EPO consider a further medical use claim to be novel when it refers to a mechanism of action which gives rise to a new clinical situation such as a new patient population or a new dosage regimen. Thus, a claim to a “Product X, for treating Y by mechanism B” is novel over the use of the same product for treating the same medical condition when that use relies upon a mechanism of action (A) which is unrelated to mechanism B (T1229/03).
TLIP advises that claims to second and further medical use can cover a broad range of clinical situations but require careful drafting for clarity and novelty. The accompanying description should refer to in vitro experiment supporting the therapeutic application.
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European Patent Attorneys
Cambridge – Leeds – Dublin