Federal Circuit Indicates Secondary Considerations . . . Just Need to be Considered

A recent decision from the Federal Circuit indicates that the order in which a court considers evidence attempting to demonstrate non-obviousness is not important, so long as it is considered. In prosecution, this translates to an increased need for strong declarations when traversing obviousness rejections.

In Eli Lilly and Co. v. Perrigo Co., the United States Court of Appeals for the Federal Circuit reviewed the findings of the United States District Court for the Southern District of Indiana related to an Abbreviated New Drug Application filed by Perrigo, attempting to make a generic version of Eli Lilly’s AXIRON® testosterone applicator. ¹ While the decision was nonprecedential, the Federal Circuit’s opinion indicates that so long as evidence of secondary considerations of nonobviousness are considered, it may not matter when that evidence is taken into account.

At the district court level, claim 20 of Eli Lilly’s U.S. Patent No. 8,435,944 (“the ‘944 patent”) was invalid as it would have been obvious in view of a combination of three prior art publications (the Aschkenasy ‘268 publication and the Cutter 2000 and 2001 references).² Eli Lilly’s primary argument against the district court’s holding was that the district court “improperly treated its secondary considerations as an afterthought.”³ Eli Lilly argued that “(1) the prior art teaches away from applying testosterone to the axilla due to concerns over causing an undesired elevated level of dihydrotestosterone (DHT); and (2) the claimed method yielded unexpected results.”⁴

In reviewing the district court’s findings, the Federal Circuit found that Eli Lilly’s alleged teaching away of the prior art was premised on statements in the art that were “less than clear” and did not demonstrate that levels of DHT were in fact elevated and undesired. ⁵ With regard to unexpected results, the Federal Circuit agreed with the district court’s finding that Eli Lilly’s alleged “seven-fold increase” in skin permeability, was based on a “flawed extrapolation of data reported in a prior art reference.” The Federal Circuit concluded that “[t]he district court thus could not have committed any reversible legal error in the order of how it considered the evidence, given that Lilly’s proffered evidence was unhelpful.” ⁶

Eli Lilly, however, argued that the district court improperly reached an obviousness determination before it considered Lilly’s evidence of secondary considerations, citing the district court’s use of the phrase “prima facie” in it’s discussion of obviousness, and the court’s focus on if the evidence could “overcome” its prima facie obviousness determination. ⁷ Eli Lilly urged that this is an error of law, requiring reversal, as “all evidence pertaining to the objective indicia of obviousness must be considered before reaching an obviousness conclusion.”⁸ The Federal Circuit determined that even if Eli Lilly’s evidence of secondary considerations “carried probative weight” (which it did not), the district court did not reach it’s conclusion of obviousness prematurely or without fully considering all the evidence before it, including the evidence of objective indicia.⁹ Rather, the district court “thoroughly considered all the arguments and evidence presented before reaching its decision.” ¹⁰

Considering this case in the context of patent prosecution, a parallel can be drawn with how and when an Examiner may consider § 132 declarations submitting evidence of secondary indicia in response to an obviousness rejection. In the years since KSR Int’l Co. v. Teleflex Inc. ¹¹, submission of expert affidavits providing evidence of secondary indicia of nonobviousness has become nearly the norm. As discussed by the Federal Circuit, it is not so much when an Examiner considers this evidence, so long as it is fully taken into account when presenting a rejection of prima facie obviousness. In view of this, patent practitioners should consider placing even more weight on providing the strongest, most persuasive evidence possible, including particular emphasis on the technical elements that may be argued (e.g., teaching away, unexpected results). As this case demonstrates, the merits of the evidence, rather than exactly how or when it is considered, are most important in trying to demonstrate nonobviousness.