Last week, in Allergan Inc. v. Apotex Inc., a panel of the Federal Circuit reversed a finding from the Middle District of North Carolina that patents covering Allergan’s Latisse® (bimatoprost ophthalmic solution) were not invalid for obviousness.  In doing so, the Federal Circuit reinforced the principle that the obviousness analysis, including secondary considerations of nonobviousness, must consider the complete scope of the claims, not just the commercial product covered by those claims.

The lawsuit involved two patents assigned or licensed to Allegan direct to a method of treating hair loss and a treatment of eyelash hair loss.  In finding the claims non-obvious, the district court limited its obviousness analysis to the properties of one specific group of compounds, and particularly, bimatoprost, and found that a person of ordinary skill would not have been motivated to use bimatoprost or other C-1 amide compounds to treat hair loss and would not have a reasonable expectation of success in the same.

The Federal Circuit criticized the district court for failing to consider the appropriate scope of the claimed invention.  This legal error resulted in an improper analysis of whether there was a motivation to combine references, a reasonable expectation of success of developing the claimed invention and secondary considerations.  The asserted claims were not limited to bimatoprost or similarly structured compounds.  Rather, the independent claims encompassed thousands of permutations of PGF analogs including structures with all kinds of functional groups.  Thus, the claims would be obvious if any compounds within the broad genus claimed were obvious at the time of the invention.  In particular, the obviousness analysis required a showing that the person of ordinary skill have a reasonable expectation of success of developing the claimed invention, not a reasonable expectation of success in developing the commercial product encompassed by the claims.

Similarly, the Federal Circuit criticized the district court’s determination on evidence of secondary considerations such as unexpected results because it again looked only at the properties of bimatoprost, which was not commensurate with the full scope of the patent’s claims.  According to the Federal Circuit, the nexus inquiry is between the scope of the claims and the alleged unexpected results and not between the commercial product and the alleged unexpected results.

The decision should serve as a reminder about the importance of evaluating the obviousness analysis in conjunction with the full scope of the claims rather than just the commercial product.