Allergan, Inc. v. Apotex Inc.

Addressing the issue of showing a reasonable expectation of success when making obviousness combinations in the context of broad genus claims, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s ruling that the asserted patents were non-obvious, finding that the district court erred by limiting the analysis to one compound covered by the broad claim.   Allergan, Inc. v. Apotex Inc., Case Nos. 13-1245; -1246; -1247; -1249 (Fed. Cir., June 10, 2014) (Prost, C.J.) (Chen, J. dissenting-in-part).

The plaintiff-appellee Allergan has FDA approval to sell Latisse®, an ophthalmic solution used to treat eyelash hair loss by stimulating growth of the eyelashes.  The defendants-appellants are generic drug manufacturers who filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Allergan’s Latisse.  Allergan sued defendants for infringement of two patents covering its hair-promoting product.  After the district court found that the defendants infringed the patents and that the patents were not invalid, the generic drug makers appealed.

The Federal Circuit reversed the district court’s obviousness ruling.  The active ingredient in Latisse is bimatoprost, which is a synthetic prostaglandin-F (PGF” analog.  For one of the asserted patents, which claims methods of treating hair loss through administration of a compound selected from the recited genus of PGF analogs, the Federal Circuit found that the claims were invalid in view of a combination of prior art references, one of which disclosed using compounds from a broad class of PGF analogs to promote hair growth.

The district court had concluded that the claims were not obvious based in part on findings that there was no reasonable expectation of success or motivation to use the claimed compounds disclosed in the prior art references to treat hair loss, and also based on evidence of unexpected results achieved with bimatoprost.  These factual findings by the district court were in large part based on evidence that one variant disclosed in the prior art reference would have resulted in a person of ordinary skill in the art not having a reasonable expectation of success of promoting hair growth with that compound.  The Federal Circuit disagreed.

In reaching its decision, the Federal Circuit did not overturn any of the district court’s factual findings, but instead explained that failure to consider the appropriate scope of the patent’s claimed invention in evaluating the reasonable expectation of success and secondary considerations constitutes a legal error that is reviewed without deference.

The patent covered a broad genus of compounds, including but not limited to the variant disclosed in the prior art reference that the district court relied on.  The Federal Circuit stated that the district court failed to make a finding on how the one variant necessarily applied to the reasonable expectation of success for the full scope of the patent’s claimed invention.  Accordingly, the Federal Circuit stated that the district court’s findings were not relevant to the patent’s actual claimed invention.

Furthermore, to establish that the evidence of unexpected results was commensurate in scope with the claims, the district court “needed to have found that other embodiments falling within the claim will behave in the ‘same manner.’” In the absence of such evidence, the district court had not made any factual finding “that would diminish the more probative facts supporting a person of ordinary skill’s substantial reasonable expectation of success and motivation to use PGF analogs” to treat hair loss as claimed in the patent.