When does an invention have enough data to support a patent application? This is a particular concern in second medical use inventions, where the invention relies on achieving a particular therapeutic effect, which may not yet have been demonstrated in clinical trials. The EPO’s approach to “sufficiency of disclosure” was recently considered in decision T 2015/20, which provides a very useful overview of the development of case law in this area.
The application in question claimed a composition for providing a specific dose of aclidinium bromide for use by inhalation for the treatment of asthma. The application was initially rejected in examination for insufficient disclosure, on the basis that the experimental evidence in the application (and a corresponding later-published scientific paper) only showed effectiveness in treatment of COPD. The EPO considered this did not make treatment of asthma plausible, in view of the different etiologies of the two conditions. The examining division also pointed to a product insert for a medicinal product containing aclinidium bromide for treatment of COPD, which warned that it was not for use in asthma, as relevant clinical studies had not been conducted.
The Board of Appeal overturned the initial decision to refuse. In their review of the EPO approach to sufficiency, the Board restated what has become an axiom of EPO case law:
“a convincing objection of lack of sufficiency of disclosure presupposes that there are serious doubts, substantiated by verifiable facts, on the possibility for a skilled person to carry out the invention as claimed”
According to the Board, the product insert cannot be taken as demonstrating any “serious doubt” since it simply warns that no official authorisation for use in asthma had been granted, and that no clinical studies were conducted. The prior art cited to support the proposition that COPD is distinct from asthma was also reconsidered, and the Board noted that, in fact, the two diseases did share some common features, albeit that the role of certain pathways (and hence classes of drugs) in asthma was reduced compared to their role in COPD. Nonetheless, this could not be understood as confirming that aclidinium bromide would not be effective in treatment of asthma; at worst the benefits of treatment may be less. Hence, no “serious doubts” as to the claimed invention existed.
The Board further note a number of other cases regarding sufficiency of disclosure in second medical use inventions, and note that a simple assertion of therapeutic use is not sufficient; some further evidence is always needed, even if this need not be experimental data for the specific condition (referring to T 609/02). The limitation to a specific dose also helped the applicant’s case, with the Board noting that this dosage information would be considered a specific technical contribution, beyond simply a vague statement of effectiveness.
This case is a helpful reminder not only of the EPO’s general approach to sufficiency, but also that it is not necessary to conclusively demonstrate a therapeutic effect in a specific disease to claim that treatment – however, it is important to be able to tell a convincing story as to why the data which is available plausibly shows that the treatment should be effective.