Docket No. 2012-1340, -1341
NEWMAN, LOURIE, BRYSON
March 18, 2014
Brief Summary: DC holding of no infringement affirmed; findings of no enablement and written description reversed. Its denial of Barr’s request for JMOL was also affirmed.
Summary: Alcon appealed final judgment of USDC DE that Barr does not infringe claims 12 and 19 of Alcon’s US 5,631,287 and 6,011,062, respectively, relating to methods for making prostaglandin compositions (including Alcon’s Travatan Z®) using polyethoxylated castor oil (“PECO”) and holding those claims invalid for lack of enablement and written description. Alcon filed suit after Barr submitted an ANDA for a generic version of Travatan Z® (filed second to that of Par Pharmaceuticals). Alcon asserted Barr’s ANDA filing was an act of infringement of the ‘287 and ‘062 patents even though those were not listed on the Orange Book (US 5510383 and 5889052 were listed but not asserted); the propriety of this was not challenged. Barr also stipulated that its generic product infringed two other Alcon patents (US 6503497 and 6849253) and that those were not invalid. The DC construed the ‘287 claim term “‘enhancing the chemical stability’ to mean ‘to increase or increasing the ability of the prostaglandin to resist chemical change (as distinguished from merely increasing the physical stability of the prostaglandin or composition), i.e., ‘reducing or decreasing [travoprost] degradation’”. It also construed the claim term “prostaglandin” to correspond to the written description “regarding the prostaglandins that may be used with the invention” (“the natural compounds PGE1, PGE2…PGF2α” (the product being a type of PGF2α prostaglandin analog)). Barr was found not to infringe because Alcon’s comparison study tested a significantly different composition from that proposed in Barr’s ANDA, and the FC panel agreed (citing Abbott Labs., FC 2002 (must compare “product that is likely to be sold following ANDA approval”)). The DC was found to have erred in its enablement analysis because “Barr failed to make the threshold showing that any experimentation is necessary…to use PECO to enhance the stability of a prostaglandin” and basing “its finding that the full scope of the claims was not enabled after applying the Wands factors as if they were a generalized test for deciding whether a patent disclosure is sufficiently detailed to support a broad claim”. In addition, Barr’s own expert testified adding a chemically-stabilizing amount of PECO to the composition was routine and made “unsubstantiated conclusory statements” (citing Cephalon, FC 2013). The opinion also explained that “a patent does not need to guarantee that the invention works for a claim to be enabled” (Pfaff, US 1998; Atlas Powder, FC 1984) or “set forth, or even know, how or why the invention works” (Newman, FC 1989) (“Thus, it is…irrelevant here, whether the ‘287 and ‘062 patents contain data proving that PECOs enhance the chemical stability of prostaglandins.”) The FC also agreed with Alcon that the specifications provide an adequate written description (various types of prostaglandins, PECOs, concentrations, osmolalities, pH values) (“demonstrate that the inventors possessed the claimed invention”). Barr also cross-appealed the DC denial to enter JMOL of noninfringment but the FC panel determined the DC did not abuse its discretion on this issue.