Endo Pharmaceuticals Inc. and Strakan Int. S.A.R.L. v. Actavis Laboratories UT, Inc. (Watson)

Docket No. 2016-1146

October 14, 2016


Brief Summary: DC decision that patents related to Endo’s transdermal testosterone gel product Fortesta® would have not have been obvious affirmed.

Summary: This opinion relates to Endo’s transdermal testosterone gel product Fortesta® and Watson / Actavis’s ANDA relating to the same (Watson filed the ANDA but transferred it to Actavis). The DC concluded the claims of Strakan’s US 6,579,865 (compositions) and 6,319,913 (methods) were not invalid for anticipation or obviousness, and that “Actavis’s marketing…would infringe all of the asserted claims”. The FC opinion explains that Actavis did not argue “that some claims are invalid even if others stand”, “a single, all-or-nothing, across-the-board obviousness argument” (“if any one of the asserted claims survives, all do”). “As a result, the prior art analysis called for by Actavis’s approach properly considers differences between prior art and any of the asserted claims.” Actavis did not appeal the decision of no anticipation but argued all the claims would have been obvious in view of “Cooper ‘872” (delivery of corticosteroids), “Cooper ‘934” (a penetration-enhancing glycol-containing vehicle), “Patel ‘970” (“mentions testosterone among many other potential active ingredients”), expert testimony (which the FC panel noted did not “say[] that Patel ‘970 teaches the three-part enhancer with propylene glycol”), Patel ‘190 (“combination of testosterone, glycerin (which the ‘913 and ‘865 patents define as a glycol), oleic acid, and ethanol”), Aungst (“combination of fatty acids, such as oleic acid, with propylene glycol” but not alcohol), and other references showing, e.g., “ethanol, as one example among many different penetration enhancers” or 5-FU as the active ingredient but not testosterone). The FC panel explained that “Actavis does not demonstrate, or even clearly argue, that any of those rerefences discloses the subject matter of all of the Endo-asserted claims-not just some claimed combinations, not just elements of claimed combinations, but all the specific combinations claimed, together with ‘consisting essentially of’ for the ‘865 patent.” The DC concluded, and the FC panel found Actavis had not persuaded them otherwise, “that a relevant skilled artisan would not have considered it obvious to bridge the gaps the separate the prior art from (at least one of) the claimed compositions and methods” (e.g., “it would not have been ‘obvious how to select and configure a particular penetration enhancer to combine with a particular level of testosterone”). The FC panel found “relevant…what specific course a relevant skilled artisan would have had reason to pursue, among a large number of possibilities, that some prior art taught that a combination of oleic acid and propylene glycol could cause ‘severe skin irritation’ whereas other enhancers would not”, finding this issue not to be predictable (noting in fn2 that Actavis’s arguments that “Fortesta® is the most irritating product on the market…impermissibly compar[ed it] to that of products that entered the market after the priority date”). It also disagreed with Actavis’s noninfringement argument that its water “plays a material role as part of the enhancer” which therefore “does not ‘consist[] essentially’ of the claim-listed components” because “Actavis, in its filings with the FDA, listed only one function for water in its product-serving as a solvent-even while it listed dual solvent/enhancer functions for other components.” Thus, the DC decision was affirmed.

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