The obviousness analysis of chemical compounds focuses mainly on the structural similarity of the claimed molecule and the compound(s) disclosed in the prior art.  In the milestone case In re Dillon, the Court of Appeals for the Federal Circuit (CAFC) held that a prima facie case of obviousness can be established only when the prior art gives a reason or motivation for a skilled person to make the claimed compound.  According to CAFC, it must be obvious for a skilled artisan to (1) select the prior art compound as a lead compound and (2) modify the lead compound to the claimed invention.  This two-part test, also known as the lead compound theory, became a stronghold of the patent owners against the patent challengers.  In pharmaceutical litigation, the generic drug manufacturers enjoyed little success in the patent validity battles against the brand name companies.  Is this status quo an indication of the absolute unpredictability of drug discovery?  This and other issues will be discussed in light of the most recent CAFC decisions.

Lead compound theory in obviousness analysis inquiry: An insurmountable obstacle for a patent challenger?

248th National Meeting (2014)

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