Testosterone – USA

On Nov 22, 2017, the Federal Circuit upheld a district court’s decision finding one patent for Axiron (testosterone solution) invalid in Perrigo, Actavis & Lupin case & other patent valid & infringed in cross appeal by Amneal.

This litigation relates to Abbreviated New Drug Applications filed by the defendants for generic equivalents of Eli Lilly’s Axiron® testosterone applicator. Eli Lilly, in turn, sued the defendants for patent infringement. After a nine-day bench trial, the district court issued a thorough, well-considered opinion over 200 pages long. Eli Lilly appeals the district court’s opinion that claim 20 of U.S. Patent No. 8,435,944 (the ’944 patent) is invalid for obviousness under 35 U.S.C. § 103. Claim 20 of the ’944 patent recites a transdermal delivery method of applying testosterone to the axilla of a patient. Amneal cross-appeals the district court’s opinion that claims 9 and 10 of U.S. Patent No. 8,807,861 (the ’861 patent) are (1) not invalid; and (2) infringed by Amneal’s applicator.

The ’944 Patent:

Federal circuit agreed with the district court that the prior art (e.g. the Aschkenasy ’268 publication and the Cutter 2000 and 2001 references) teach and suggest that applying testosterone to the axilla will increase a patient’s testosterone level with a reasonable expectation of success. Eli Lilly’s arguments against those references lack merit and/or are based on a misreading of the lower court’s opinion. Eli Lilly 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 the claimed method yielded unexpected results. As the district court noted, Eli Lilly’s teaching away theory rested on a position that the scrotal skin and the axilla have comparably high 5-alpha reductase activity, which can result in an elevated DHT level. But Lilly’s reference to support that assertion, Takayasu, did not include measurements from the scrotal area in its study. Thus, even if the prior art sought to avoid areas that had the same level of 5-alpha reductase activity as scrotal skin, Lilly did not present any evidence that the axilla and scrotal skin have comparably high activity. Thus, the district court correctly found, on this record, that the only teaching relating to DHT levels in the axilla was by Cutter, which reported a normal DHT level after application of testosterone to the axilla.

On unexpected results, Federal circuit held that Eli Lilly made no meaningful argument contesting the district court’s rejection of Lilly’s theory of unexpected results. On review, we see no error in the district court’s explanation that Lilly’s asserted ‘seven-fold increase’ in skin permeability was based on a flawed extrapolation of data reported in a prior art reference. In sum, the lower court correctly found that Lilly’s objective indicia lacked weight. As a result federal circuit uphold the district court’s judgment of invalidity.

The ’861 Patent:

Claims 9 and 10 of the ’861 patent are directed to an applicator with a “resiliently deformable wall” used to administer a testosterone solution to the axilla. Federal circuit detected no error in the district court’s conclusions that the claims, as construed, are not invalid over the asserted prior art (e.g. Gueret ’187 and Gueret ’986) and were infringed by Amneal’s applicator. As to Amneal’s argument that its applicator does not infringe because it does not deform in a “blade-like manner,” the phrase “blade-like manner” appears nowhere in the claims and appears only in the context of a specific embodiment in the specification. Thus, federal circuit agreed with the district court that the claims require only that the applicator wall be “resiliently deformable” and do not require a specific mode of resilient deformation.

Federal circuit finally considering entire appellant’s and cross-appellant’s other arguments affirmed the district court's decision.