In Shire Development. LLC v. Watson Pharmaceuticals, Inc., [2016-1785] (February 10, 2017), the Federal Circuit reversed a finding of infringement because the accused product did not meet the Markush claim element, and remanded for entry of an order of non-infringement.<\/p>\n
The claims of U.S.\u00a0Patent No. 6,773,720 required:<\/p>\n
an outer hydrophilic matrix wherein the\u00a0lipophilic matrix is dispersed, and said\u00a0outer hydrophilic matrix consists of compounds\u00a0selected from the group consisting\u00a0of polymers or copolymers of acrylic or\u00a0methacrylic acid, alkylvinyl\u00a0polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses,<\/p>\n
polysaccharides, dextrins, pectins,<\/p>\n
starches and derivatives, alginic acid, and\u00a0natural or synthetic gums<\/p><\/blockquote>\n
After noting that a\u00a0Markush claim is a particular kind of patent claim\u00a0that lists alternative species or elements that can be\u00a0selected as part of the claimed invention, the Federal Circuit pointed out that the Markush elements used the language “consisting of” which is presumed to be closed to additional elements. \u00a0\u00a0Though the \u201cconsisting of\u201d presumption is very strong,
\nthere have been rare exception for \u201caspects unrelated to the
\ninvention.\u201d<\/p>\nThe Federal Circuit found that magnesium stearate, an excipient
\nnot within the claim 1(b) Markush group, was present in the\u00a0outer hydrophilic matrix, and thus the\u00a0claim 1(b) limitation was\u00a0literally violated. \u00a0The district court nonetheless found infringement because the component outside of the Markush\u00a0group\u2014i.e., the lipophilic magnesium stearate in the\u00a0hydrophilic outer matrix\u2014was unrelated to the invention. \u00a0The Federal Circuit disagreed\u00a0with the district court\u2019s interpretation of what constitutes a component unrelated to the invention. \u00a0The Federal Circuit found that the magnesium stearate structurally and\u00a0functionally relates to the invention, and its presence in\u00a0the outer matrix violates the \u201cconsisting of\u201d requirement\u00a0in claim 1(b).<\/p>\nWhile the\u00a0magnesium stearate was included as a lubricant, rather than for its lipophilic properties,\u00a0this was not sufficient to overcome the strong presumption of the closed nature of the claim. \u00a0Even the fact that examples in the patent included magnesium stearate was insufficient to overcome this strong presumption.<\/p>\n","protected":false},"excerpt":{"rendered":"
In Shire Development. LLC v. Watson Pharmaceuticals, Inc., [2016-1785] (February 10, 2017), the Federal Circuit reversed a finding of infringement because the accused product did not meet the Markush claim element, and remanded for entry of an order of non-infringement. … Continue reading