A pharmaceutical company specializing in generics launched in France a generic version of Xarelto (rivaroxaban) immediately after expiry of the compound patent and of the associated SPC. The patent owner of the lapsed compound patent and of the SPC also owned a later “dosage regimen” patent claiming a specific posology of rivaroxaban for the treatment and prevention of thromboembolic disorders. Before marketing its own product, the generics company brought an action seeking the revocation of the French part of this posology patent for lack of inventive step.
As already held by the EPO, when the fact that a clinical study is underway is disclosed prior to the priority date or publication date of a patent application, a person skilled in the art is led to consider that there is sufficient expectation of success in the treatment to render the invention devoid of inventive step.
An interesting point of this decision relates to clinical trials. The requirement to obtain free and informed consent in clinical research means that patients need to be told about the purpose, methods, trial treatments, and expected benefits of the study. With regard to disclosure in the context of clinical trials, the EPO considers that if a single member of the public, who is not subject to any obligation of secrecy, has the opportunity to access specific information, that information is considered to be accessible to the public
In this case, the consent forms and explanatory booklet distributed to patients do not expressly require confidentiality on the part of patients participating in the study; only a confidentiality clause is mentioned for information collected during the study, i.e., after the consent form has been signed.
Furthermore, two doctors who participated in the study, including the one who led it, have attested that patients were encouraged to share the content of the consent form and the study with their families, friends, or doctors, so that patients, even though they, like doctors, are necessary agents in these experiments, cannot be considered to have an implicit obligation of confidentiality to the defendant company.
The clinical trial was therefore taken into account to assess inventive step of the invention. The skilled person would have been encouraged to embark on the path of invention with a reasonable hope of success, especially since the search for a suitable dosage involves routine testing, leading to invalidation of claims 1 and 2 as granted.