EPO Ruling On Inventiveness Of Drug Polymorphs

Thank you to Dr. Stefan Danner, a German and European Patent Attorney at DHS Patentanwaltsgesellschaft mbH in Munich for letting us post the current issue of the biotech IP newsletter dealing with the recent EPO decision concerning the patentability of drug polymorphs. A PDF of the entire newsletter is attached at the end of this post.

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On May 24, 2011, the EPO Technical Board of Appeal (TBA) 3.3.01 handed down decision T777/08 concerning the inventiveness of (specific) polymorphic forms of a drug previously only known in solid amorphous form. This decision caused considerable attention in the pharmaceutical industry.

The relevant claimed subject matter of European Patent EP 1 148 049 relates to crystalline forms II and IV of the statin drug atorvastatin hydrate that are characterized by an X-ray powder diffraction pattern expressed in terms of 20 angles, d spacings, and relative intensities with a relative intensity of >15% determined using CuKα radiation.

The full document can be found here 10.11. Inventive Polymorphs.

 

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