In an appeal decided last month, the Federal Circuit affirmed a decision by the District Court for the Southern District of Indiana finding claim 20 of U.S. Patent No. 8,435,944 to be invalid as obvious.  The panel also affirmed the District Court's finding that claims 9 and 10 of U.S. Patent No. 8,807,861 were valid and infringed.

Seeking approval to market generic versions of Eli Lilly's Axiron® testosterone applicator, Defendants Perrigo Company and Perrigo Israel Pharmaceuticals Ltd., Actavis Laboratories UT, Inc., FKA Watson Laboratories Inc., Lupin Pharmaceuticals, Inc. and Lupin Ltd., and Amneal Pharmaceuticals LLC filed Abbreviated New Drug Applications (ANDAs) with the FDA.  In response to those ANDA filings, Eli Lilly brought suit against the Defendants for patent infringement.

With respect to claim 20 of the '944 patent, which is directed to a transdermal delivery method of applying testosterone to the axilla of a patient, the District Court determined that three prior art references teach and suggest that applying testosterone to the axilla will increase a patient's testosterone level with a reasonable expectation of success.  The District Court therefore found claim 20 to be invalid as obvious.

On appeal, Lilly argued that the District Court improperly reached a "prima facie" decision of obviousness and treated its secondary considerations as an afterthought.  With respect to secondary considerations, Lilly had argued that the prior art teaches away from applying testosterone to the axilla due to concerns over causing an undesired elevated level of dihydrotestosterone (DHT), and that the claimed method yielded unexpected results.  The District Court, however, determined that the only reference relating to DHT levels in the axilla reported a normal DHT level after application of testosterone to the axilla, and that Lilly's assertion of unexpected results was based on a flawed extrapolation of data reported in a prior art reference.  According to the Federal Circuit, "[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," and the panel therefore determined that "the lower court correctly found that Lilly's objective indicia lacked weight."

As for Lilly's argument that the District Court improperly reached a "prima facie" decision of obviousness, the Federal Circuit explained that "even if Eli Lilly's secondary consideration/objective indicia evidence carried probative weight, there is nothing to indicate that the [district] court reached the ultimate conclusion of obviousness prematurely, or without fully considering all the evidence before it, including the evidence of objective indicia."  Thus, the panel did not find that the District Court's admitted use of phrase "prima facie" constituted reversible error in this case, "since it does not accurately reflect what the district court actually did."

With respect to claims 9 and 10 of the '861 patent, which are directed to an applicator with a "resiliently deformable wall" used to administer a testosterone solution to the axilla, the District Court determined that the claims were not anticipated or obvious over two prior art references.  The District Court also found that claims 9 and 10 of the '861 patent were infringed by Amneal's applicator.

On appeal, the Federal Circuit noted that "Amneal offers a plethora of record citations as proof that it had raised below its newly-minted argument [that one reference cited by Amneal discloses the double wall required by the claims as construed]."  But after "carefully review[ing] every single one of Amneal's citations," the Court "did not find any testimony or briefing showing [that Amneal] argued that annular rib 204 together with annular rib 201/202 form a double-wall structure."  The Federal Circuit, therefore, concluded that "[t]he district court accordingly never addressed this theory."  As for Amneal's argument that its applicator did not infringe claims 9 and 10 of the '861 patent, the Federal Circuit determined that Amneal's argument relied on a specific interpretation of the claims that went beyond the District Court's construction.  The Federal Circuit therefore found Amneal's arguments to be unpersuasive, and affirmed the District Court's finding that claims 9 and 10 of U.S. Patent No. 8,807,861 were valid and infringed.

Eli Lilly and Company v. Perrigo Co. (Fed. Cir. 2017)
Nonprecedential disposition
Panel: Circuit Judges Chen, Plager, and Hughes
Opinion by Circuit Judge Chen