T 108/09 – De Novo

In this opposition appeal case Board 3.3.02 had to decide on the novelty of claim 1 as granted, which read:

1. Use of fulvestrant in the preparation of a medicament for the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment. (my emphasis)

[2.3.1] Document D2 discloses the use of fulvestrant (ICI 182,780) for the second-line treatment of breast cancer after tamoxifen failure […]. It therefore has to be determined whether or not the change from second-line treatment to third-line treatment, expressed in claim 1 as granted by the feature “who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment”, can establish novelty. In this context, it is noted that, as was correctly pointed out in the decision under appeal, this feature does not relate to the presentation of information (A 52(2)(d)) by merely describing the medical history of the patient but constitutes a technical feature. This can be deduced from document D2, according to which tamoxifen cannot cure breast cancer, as drug resistance will develop […], which means that physiological changes in the tumour occur in the course of tamoxifen administration. As a consequence, this feature has to be taken into consideration for the evaluation of novelty and inventive step.

According to decision G 2/08, A 54(5) does not exclude a medicament already known to be used in the treatment of an illness from being patented for use in a different treatment by therapy of the same illness. This finding applies mutatis mutandis to the Swiss-type claims of the patent in suit (see G 2/08 [order]). G 2/08 [5.10.7] also refers to “well-established case law” which includes decisions T 19/86, T 893/90 and T 233/96, all of which pertain to a novel group of subjects treated and were relied on by the appellant-opponent.

Although decision T 233/96, by taking into consideration the jurisprudence created by T 19/86 and T 893/90, attempts to define general criteria which must be met for a particular group of subjects to establish novelty and/or inventive step in a Swiss-type claim (see T 233/96 [8.7]), this board concludes that these three decisions relate to three different situations which have to be distinguished from one another.

(a) In decision T 19/86, a new group of subjects (sero-positive piglets) was vaccinated against the same disease (Aujeszky’s disease) against which vaccination had already been disclosed for sero-negative piglets. This means that in this case the group of subjects to be treated does indeed constitute the distinguishing feature over the prior art.

(b) Decision T 893/90 concerns the use of a composition for controlling bleeding in non-hemophilic mammals as compared to the use of the same composition for controlling bleeding in hemophilic subjects. Here, unlike T 19/86 where the disease according to the claims is identical to the disease defined in the prior art, the group of subjects (non-hemophilic mammals) serve to further define the disease or pathological symptoms to be treated (bleeding) and the disease or pathological symptom thus defined (non-hemophilic bleeding) is different from the disease of the prior art (hemophilic bleeding). As a consequence, T 893/90 concerns the classical case in which the disease to be treated constitutes the distinguishing feature of a Swiss-type claim over the prior art.

(c) Decision T 233/96 is of no importance to the present case. It concerns a diagnostic method for detecting the presence, or assessing the severity, of vascular disease of coronary arteries, for which novelty was denied as no functional relationship existed between the incapability of a patient to exercise adequately (group of subjects) and the pharmacological effect achieved by administration of the active agent in the diagnosis of various types of coronary disease (see point [8.8]).

In the light of these decisions, and in particular in the light of decision T 893/90, the board considers it appropriate to evaluate whether the breast cancer of claim 1 as granted is identical to the breast cancer according to document D2. In the first paragraph of point [2.3.1], it has already been concluded that tamoxifen resistance leads to physiological changes in the tumour, which means that the tumour can be distinguished from the same tumour before tamoxifen resistance set in. It would stand to reason that the same development would be observed with the aromatase inhibitor. Resistance would set in after a certain period of time, leading to physiological changes in the tumour. However, the appellant-opponent contested this, pointing out that in some cases there was de novo resistance to aromatase inhibitors. Reference was made to document D10, which concerns a phase II clinical study of the clinical benefit of fulvestrant in post-menopausal women with advanced breast cancer. This study included in group B […] patients who did not respond to aromatase inhibitor treatment and were therefore de novo resistant […].

De novo resistance means that the tumour does not change during treatment with an aromatase inhibitor. In view of the existence of de novo resistance to aromatase inhibitors, it might be argued that the group of patients treated in document D2 inevitably included patients with de novo resistance to aromatase inhibitors. For these patients, fulvestrant would inadvertently be used as a third-line agent, so that there was lack of novelty with respect to this particular patient group. However, the board cannot agree with that argumentation. The fact that document D10 mentions patients with de novo resistance to aromatase inhibitors does not mean that this kind of resistance is ubiquitous. As a consequence, document D2, which does not mention de novo resistance to aromatase inhibitors, does not implicitly disclose third-line treatment involving fulvestrant, so that the tumours of document D2, being only resistant to tamoxifen, can be distinguished from the tumours of claim 1 as granted, which are additionally resistant to an aromatase inhibitor. This distinction means that two different diseases or two subsets of a disease (tumour) are concerned, which in analogy to the findings in point 2.3.1 (b) above establishes novelty. The subject-matter of claim 1 as granted is therefore novel over document D2.

[2.3.2] The reasoning of paragraph [2.3.1] above also applies to the novelty of claim 1 as granted vis-à-vis document D3, which also discloses the use of fulvestrant (ICI 182,780) for the second-line treatment of breast cancer after tamoxifen failure […].

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