Bayer v.
Unipharm
Crystalline sorafenib tosylate · patent opposition and appeal
Unipharm opposed Bayer’s Israeli patent application concerning polymorph I of sorafenib tosylate. The opposition was accepted on the ground that the claimed invention lacked inventive step.
When routine polymorph screening meets inventive step.
The proceedings examined whether the claimed crystalline form reflected an inventive contribution, against prior art concerning sorafenib tosylate and the ordinary work of identifying and characterizing pharmaceutical polymorphs.
The Patent Office rejected the application for lack of inventive step. Bayer appealed that ruling to the Tel Aviv District Court.
Bayer’s appeal was dismissed.
On 8 August 2023, the Tel Aviv District Court dismissed Bayer’s appeal, leaving in place the Patent Office decision rejecting the application. The judgment addressed a central inventive-step question in polymorph cases: unexpected properties do not by themselves establish inventiveness where the claimed form can be reached through routine screening guided by the prior art. The Court emphasized that inventive step may be denied where the prior art points toward the route taken and ordinary methods lead to the claimed form without special difficulty.