CABINET CHAILLOT

T0670/20

Appeals were filed against the interlocutory decision of the opposition division that patent 2140867 as amended met the requirements of the EPC.
Claim 1 as maintained relates to:
"A pharmaceutical composition,
wherein the composition is a coated tablet,
wherein the coated tablet is a tablet coated with at least one coating agent selected from the group consisting of hypromellose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, and polyvinyl alcohol,
wherein the tablet comprises:
 (A) N¹-(5-chloropyridin-2-yl)-N²-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetra hydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}­ cyclohexyl)ethanediamide, represented by formula (1), a pharmacologically acceptable salt thereof, or a hydrate of any of these;
 (B) a sugar alcohol; and
 (C) pregelatinised starch or crystalline cellulose as a water-swelling additive."
The compound of formula (1) is herein further referred to by its present common name "edoxaban".
Documents D19 and D20 relate to phase IIa and phase IIb clinical trials in which patients received treatment involving administration of edoxaban. The clinical trials described in documents D19 and D20 had started before the priority date claimed for the patent and the trials concerned edoxaban tablets which were covered by the definition of claim 1 of the main request.
The assessment of the ground of lack of novelty in view of the trials described in documents D19 and D20 therefore crucially depends on whether the participating patients who received the tablets are to be considered as members of the public who were free to dispose over the provided tablets and thus theoretically in a position to investigate the internal structure of the tablets.
The set-up of the trials of documents D19 and D20 implies that the patients who decided to participate in the trials agreed, following their informed consent, to use the provided medication according to instruction or to return the unused medication.
Accordingly, the participating patients who were provided with the tablets under investigation entered into a special relationship with the investigators of the trials and were with regard to the provided tablets not members of the public that could freely dispose over these tablets.
The Board notes that the patients' agreement obliges the patients irrespectively of any sanction on non-compliance and therefore disqualifies the patients as members of the public with respect to the medication provided to them.
The possibility of non-compliance to the instructed use and return of the tablets by the participating patients does not affect the essence of this agreement.
In T 7/07 the competent board concluded on the basis of the available information that apparently the sponsor of the trial had effectively lost control over the drugs after these had been handed out to the participants of the trial as members of the public who were not bound to secrecy. In the present case the tablets were not provided to the participants of the trial as members of the public, which distinguishes the circumstances of the trials of documents D19 and D20 from the circumstances of the trial considered in T 7/07.
Accordingly, the Board agrees with the finding in the decision under appeal  that the public did not gain access to the claimed tablets during the trials reported in documents D19 and D20 and that the main request therefore complies with the requirement of novelty.
Document D3 discloses edoxaban hydrochloride in a list of examples of anti-thrombotic agents which may be formulated with suitable additives, for instance in the form of a tablet. D3 does not reveal the constitution of an actual tablet comprising edoxaban.
The results in the patent demonstrate that the choice of the components and coated structure of tablets as defined in claim 1 of the main request contribute to the rapid dissolution rates of the tablets.
Accordingly, the Board considers that the problem to be solved may be formulated as the provision of a solid pharmaceutical composition comprising edoxaban as active ingredient which allows for excellent dissolution properties.
The cited prior art provided the skilled person with no reasonable expectation that the use of a combination of a sugar alcohol with pre-gelatinized starch or crystalline cellulose as a water-swelling additive allowed the dissolution of tablets comprising edoxaban to be still further enhanced by coating the tablet with a coating agent as defined in claim 1.
The skilled person would therefore not have arrived as a matter of obviousness at a tablet as defined in the main request in order to provide a pharmaceutical composition comprising edoxaban which allows for excellent dissolution properties.
The appellants argued that the defined coated structure and the defined excipients were entirely conventional for immediate release tablet formulations, in view of which any unexpected dissolution characteristics would represent a mere bonus effect.
The Board observes that technical effects associated with the distinguishing features of a claimed invention have been disregarded as a mere "bonus effect" in the jurisprudence of the Boards of Appeal in special cases in which the skilled person was actually bound to arrive at the claimed subject-matter, for instance because alternatives were absent for solving a realistic technical problem and the skilled person was thus in a so-called "one-way street" situation.
In view of the availability of alternative excipients for preparing tablets it is not evident that starting from document D3 the skilled person was bound to arrive at the coated tablets as defined in accordance with the main request. The Board finds therefore no convincing reason to dismiss the excellent dissolution properties of the claimed tablets as a mere bonus effect.
Accordingly, the Board agrees with the decision under appeal that the subject-matter of claim 1 of the main request also involves an inventive step.
The appeals are dismissed.

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