Register | Login
Intellectual Property Today
RFC Express - Document Management System

Assessing the Obviousness of Enantiomerically Pure Pharmaceutical Products: Developments in Post-KSR Caselaw

By David Galluzzo and Monica Bhattacharyya 1

The full impact on different technological areas of the Supreme Court's decision in KSR Int’l Co. v. Teleflex, Inc., ("KSR") has yet to be felt.  The KSR court rejected the Federal Circuit's "rigid approach" to obviousness in favor of a more "expansive and flexible" approach where "[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability."  While KSR involved a patent claim directed to a mechanical invention, its reasoning will likely have wide-ranging impact in those technical areas where patentability depends on what may be regarded as small or incremental differences from the prior art.  In the pharmaceutical area, for example, an obviousness challenge to a claimed compound is typically based on similarities between its chemical structure and structures of prior art compounds, which can easily and incorrectly be characterized as obvious.

One promising area for research and development of new drugs is based on purification of "enantiomers" — two mirror image versions of a chemical compound, a left-handed and a right-handed variety — in comparison to "racemates," which are mixtures of the compound's left-handed and right-handed forms.  Enantiomers have nearly identical physical properties but may have divergent pharmacolo...

To view the complete article you must be logged in
Login Now

Not A Member Yet? Sign Up For A Free 10 Day Trial Account!

  © Copyright 2010 Intellectual Property Today
Download Adobe Reader for free