New Patent Examination Guidelines For Pharmaceutical Solid Forms Proposed By CIPO

The Canadian Intellectual Property Office (CIPO) has proposed new patent examination guidelines for pharmaceutical solid forms, including polymorphs, salts, hydrates, solvates, desolvates and co-crystals.¹ The proposed guidelines are intended to provide "certainty and consistency" in the patent examination process but signal more stringent examination requirements for these solid forms.

What You Need To Know

• If approved, the proposed patent examination guidelines will appear in the Manual of Patent Office Practice (MOPOP). The MOPOP is a guide outlining Canada's patent examination practice, and does not have the force of law.
• The proposed guidelines address the tests for anticipation, obviousness, utility, indefiniteness and unity of invention in relation to crystalline forms of small molecules, and provide specific commentary with respect to polymorphs, salts, hydrates, solvates, desolvates and co-crystals.