Docket No. 2016-1785
PROST, TARANTO, HUGHES
February 10, 2017
Brief Summary: DC decision that Watson’s ANDA Product to Shire’s Lialda® reversed for not meeting the Markush requirements of the claims.
Summary: Shire sued Watson for infringement of US 6,773,720 directed to a controlled-release oral mesalamine (mesalazine or 5-amino-salicylic acid) composition for treatment of inflammatory bowel diseases (Shire, FC 2015, remanded and vacated by SCOTUS) by Watson’s ANDA 203817. Claim 1 requires “an inner lipophilic matrix consisting of substances selected from the group consisting of” various compounds, “an outer hydrophilic matrix…consist[ing] of compounds selected from the group consisting of” various compounds, and “optionally other excipients….” The DC determined that “[w]hen a matrix is hydrophilic, it ‘has an affinity for water’ and therefore ‘readily dissolves in’ it” (stipulated to by the parties as “having an affinity to water”) and “when…lipophilic, it ‘has an affinity for lipids’ and therefore ‘resists dissolving in water” (stipuled as having a “poor affinity towards aqueous fluids”). In its 2015 decision (including after remand), the FC determined the ‘720 matrices as having “mutually exclusive spatial characteristics-one inner, one outer-and mutually exclusive compositional characteristics-one hydrophilic, one lipophilic” and “that a ‘matrix-not just an excipient within the matrix’-must exhibit the appropriate characteristic” (“the inner volume contains substances from the group described for the inner lipophilic matrix (which are all lipophilic substances), and the outer volume separately contain substances from the group described for the outer hydrophilic matrix (which are all hydrophilic)”). In addition, it concluded “that the matrix compositions are ‘limited by the Markush groups’ added during prosecution ‘to overcome the examiner’s rejection of the claims as obvious.” The DC determined Watson’s ANDA Product satisfied these limitations since “the excipients falling outside the respective Markush groups were ‘unrelated’ to the invention since they did not drive the water-affinity property of their respective matrices.” The FC panel explained that it reviews a DC’s conclusions of law de novo and its finding of fact for clear error (Allergan, FC 2015) and that use of “consisting of” or “consists of” “creates a very strong presumption that that claim element is ‘closed’ and therefore ‘exclude[s] any elements, steps, or ingredients not specified in the claim” (Multilayer, FC 2016). And that presumption can only be overcome where “‘the specification and prosecution history’…’unmistakably manifest an alternative meaning,’ such as when the patentee acts as its own lexicographer” (Multilayer, FC 2016; Norian, FC 2004 (infringement not avoided by the addition of a spatula to a calcium phosphate chemical kit claim since it “has no interaction with the chemicals, and is irrelevant to the invention.”) The FC panel concluded “Watson’s ANDA Product does not facially satisfy the claim 1(b) Markush limitation” (“outer hydrophilic matrix”) by the inclusion of magnesium stearate which is outside of the Markush group but that the DC, in finding infringement based in part on expert testimony, concluded was “unrelated to the invention” (“not sufficiently lipophilic to render the outer matrix lipophilic” (as Shire also argued here). The FC panel, in contrast, concluded it “structurally and functionally relates to the invention” (“Norian did not restrict ‘related’ components to only those that advance or are intended to advance a Markush group’s allegedly inventive elements” and “consisting of” not equivalent to “comprising” (“open-ended”) or “consisting essentially of” (other components that “do not ‘materially affect the basic and novel properties of the invention’” may be included). And Shire’s argument that the examples include magnesium stearate in the outer matrix was not found to “‘overcome the exceptionally strong presumption’ that Markush groups are closed.” Thus, the DC decision was reversed.