T 1079/18 - Febuxostat II and III

Key points

•  This is another patent directed to Form I of Febuxostat , now having the additional feature that it is a pharmaceutical composition "wherein the at least one pharmaceutically acceptable excipient is selected from the group consisting of fillers, sweeteners, buffering agents, glidants, flowing agents, flavouring agents, lubricants, preservatives, surfactants, wetting agents, binders, disintegrants and thickeners."
• The filing date is in 2011.
• The Board comes to the same conclusion:  "by performing a DSC analysis of form A, the skilled person aiming at higher solubility would have identified form I as being the desired form, i.e. a higher-melting form that results from form A by an endothermic phase transition at higher temperatures. In view of the heat-of-transition rule, they would have expected form I to be an enantiotrope of form A and form I to have a higher solubility than form A at temperatures below the transition temperature (somewhere between approx. 175 and 200 °C), i.e. at ambient temperature. Further, the fact that form I merely retains the non-hygroscopicity of form A (in the absence of a comparison, one cannot speak, at any rate, of an improvement - see above) can be considered merely as a bonus effect that the skilled person inevitably achieves because they are primarily looking for a crystalline form of febuxostat with higher solubility."
• The claims are found to be obvious, and the patent is revoked.
• In decision T 0546/21, a separate patent for a method using the crystalline form to prepare a pharmaceutical composition is also revoked. 
• Oral proceedings in cases T 1065/18 and T 1079/18 were joined and lasted until 18:00; oral proceedings in case T 0546/21 were held the next day and took only an hour. 

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t181079eu1.html