Patenting Polymorphs At The European Patent Office

Obtaining patents for polymorphs can be challenging. However, before the European Patent Office, there is no general rule which makes polymorphs less patentable in principle than other subject matter. With careful drafting and consideration of any specific advantages associated with the polymorph of interest, European patents directed to polymorphs of commercial significance can be obtained. Such patents can act as additional barriers to entry of generic products onto the market, and can thus be very useful in managing the life cycle of a patent estate for pharmaceutical and other biologically active compounds.

Introduction

A solid form of a small molecule may be amorphous (when there is no long range order in the orientation of the small molecules) or crystalline (when the small molecules are arranged in a periodic crystal structure). Many small molecule pharmaceutical compounds exist in a number of different crystalline forms, often known as polymorphs.