Non-enabling disclosure as prior art?
Patents relating to AstraZeneca’s anti-cancer drug Faslodex have been heavily litigated in many jurisdictions. In Switzerland, registration EP(CH) 2 266 573 B1 was revoked by the Patent Court in August 2017 for lack of inventive step due to pre-published scientific articles Howell and McLeskey (see O2015_011). AstraZeneca appealed and the Supreme Court has remitted the case back to the Patent Court to reassess whether the claimed subject matter involves an inventive step.
The parties disagreed on whether Howell contained an enabling disclosure. The Patent Court had held that it did and that, in accordance with the problem-and-solution approach, the objective technical problem was only the provision of an alternative formulation for sustained release. However, on appeal AstraZeneca argued that the Patent Court had erroneously assumed that Howell contained a concrete pharmaceutical formulation, thus incorrectly defining the distinguishing features and objective technical problem, and therefore ultimately wrongly concluding that there was a lack of inventive step.
The Supreme Court agreed and remitted the case for reassessment on the basis of an ‘objectively correct’ definition of the problem. It is rare that the Supreme Court redefines the objective technical problem in the assessment of inventive step; it did so here because the Patent Court had wrongly defined ‘enabling disclosure’. The Supreme Court held that the Patent Court had failed to recognise the concept of feasibility or sufficient disclosure. It concluded that “the technical teaching of Howell could basically be reworked”, as a technical teaching consists not only of the problem but also the solution. In sum, the Supreme Court held that the Patent Court had incorrectly applied the legal concept of enablement with the assumption that no concrete technical formulation was required in order to affirm that Howell contained a technical teaching.
Further, the Supreme Court concluded that the Patent Court had failed to identify the differentiating features, as it could not have done so correctly because there was no specific disclosure in Howell.
The Patent Court had left it undecided whether a non-enabling disclosure is prior art under Article 54(2) of the European Patent Convention. However, the Supreme Court held that Howell does constitute prior art. In the Supreme Court’s view, such prior art cannot be assessed with the European Patent Office’s (EPO’s) problem-and-solution approach, as the objective technical problem is simply to find a working solution to what is insufficiently disclosed.
This is a remarkable conclusion which does not appear to be consistent with the EPO’s approach. According to the EPO, subject matter is regarded as having been made available to the public, and therefore part of the prior art pursuant to Article 54(1), only if the information given to the skilled person is sufficiently enabling to practise the technical teaching (Guidelines, G-IV, 2); if it is not, the disclosed subject matter is irrelevant.
While we await the implications of this decision, it seems clear that questions of enablement (which have often been poorly treated) will be discussed more frequently in future nullity cases. It remains to be seen how the Patent Court will deal with the remitted case.
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