{"id":151498,"date":"2022-09-21T15:15:26","date_gmt":"2022-09-21T19:15:26","guid":{"rendered":"https:\/\/ipwatchdog.com\/?p=151498"},"modified":"2022-09-21T17:00:44","modified_gmt":"2022-09-21T21:00:44","slug":"novartis-appeal-cafcs-unprecedented-u-turn-ruling-multiple-sclerosis-drug-claims-scotus","status":"publish","type":"post","link":"https:\/\/ipwatchdog.com\/2022\/09\/21\/novartis-appeal-cafcs-unprecedented-u-turn-ruling-multiple-sclerosis-drug-claims-scotus\/id=151498\/","title":{"rendered":"Novartis to Appeal CAFC\u2019s \u2018Unprecedented\u2019 U-Turn in Ruling on Multiple Sclerosis Drug Claims to SCOTUS"},"content":{"rendered":"
\u201cWithout hyperbole, this procedural insanity is literally unprecedented.\u201d- Gene Quinn<\/p>\n<\/div>\n
<\/a>Novartis Pharmaceuticals announced today<\/a> that it will appeal the U.S. Court of Appeals for the Federal Circuit\u2019s (CAFC\u2019s) June decision<\/a> invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case.<\/p>\n The CAFC in June vacated a different three-judge panel\u2019s January opinion<\/a> upholding Novartis\u2019 U.S. Patent No. 9,187,405<\/a>. In the original ruling, Chief Judge Moore had dissented from the majority; in the rehearing, Moore authored the opinion vacating the January decision, with Judge Linn dissenting.<\/p>\n The January decision had affirmed the District of Delaware\u2019s final judgment that Novartis\u2019 patent claims covering the multiple sclerosis treatment were not invalid for failing to satisfy the written description requirement under 35 U.S.C. \u00a7 112<\/a>. In the June decision, the panel majority noted that adequate written description for a negative claim limitation exists when \u201cthe specification describes a reason to exclude the relevant [element],\u201d citing to the Federal Circuit\u2019s 2012 per curiam <\/em>ruling in Santarus, Inc. v. Par Pharmaceutical, Inc.<\/em><\/a> \u201cSilence is generally not disclosure,\u201d wrote Chief Judge Moore, reiterating a point she raised in her January dissent.<\/p>\n The January precedential decision, authored by Judge O\u2019Malley and joined by Judge Linn, ruled in favor of Novartis, with Chief Judge Moore dissenting. Subsequently, after receiving a three-week extension, HEC filed a request for panel rehearing, with Novartis filing a response thereafter. One week after Novartis filed its response, Judge O\u2019Malley retired. Judge Hughes was assigned to consider the request for panel rehearing along with Judge Linn and Chief Judge Moore, and despite not being a member of the original panel, Judge Hughes agreed with Chief Judge Moore that a panel rehearing should be ordered. Upon panel rehearing, Chief Judge Moore\u2019s dissenting view became the majority opinion, with Judge Linn this time dissenting.<\/p>\n