{"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

\"Novartis<\/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

Weighing in on the June decision, IPWatchdog Founder and CEO Gene Quinn said<\/a> in August that \u201c[w]ithout hyperbole, this procedural insanity is literally unprecedented.\u201d He noted that Novartis\u2019 brief asking for panel rehearing, and alternatively for en banc <\/em>review, pointed out that the Federal Circuit is the only Court of Appeals in the country that does not have a rule that requires at least one member of the majority to vote for a panel rehearing to be ordered.<\/p>\n

In today\u2019s statement, Novartis said that it expects FY 2022 sales to be negatively impacted by USD 300 million if generics launch in the United States. It added: \u201cPreviously, Novartis entered into settlement agreements with a number of ANDA filers. Under these settlements, those ANDA filers would have been able to launch a generic version of Gilenya, if approved by FDA, on an agreed upon date that is prior to the expiration of the dosing regimen patent, or earlier than the agreed upon date under certain circumstances. With this decision, HEC and other ANDA filers with FDA approval will potentially be able to launch a generic version of 0.5mg Gilenya imminently, pending any other judicial actions.\u201d<\/p>\n

Quinn in August said that the January O\u2019Malley-Linn majority ruling \u201cmakes perfect sense to anyone familiar with the written description law because it is perfectly consistent with the Federal Circuit\u2019s en banc <\/em>ruling in [<\/em>Ariad Pharms., Inc. v. Eli Lilly & Co.,<\/em>\u00a0598 F.3d 1336<\/a>, 1351 (Fed. Cir. 2010)], which requires the analysis of the sufficiency of the disclosure to be viewed through the eyes of one of skill in the art.\u201d He said that Chief Judge Moore\u2019s analysis \u201cadopted a new limitation on disclosure that has no prior basis in law, and in fact directly contradicts the Federal Circuit\u2019s en banc <\/em>ruling in [Ariad]<\/em>.\u201d<\/p>\n

Quinn added: \u201cWhen something like this happens, the arbitrary nature of the crapshoot that is an appeal to the Federal Circuit is undeniably, and rather disgustingly, displayed out in the open for even casual observers to see.\u201d<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Novartis Pharmaceuticals announced today that it will appeal the U.S. Court of Appeals for the Federal Circuit\u2019s (CAFC\u2019s) June decision 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. The CAFC in June vacated a different three-judge panel\u2019s January opinion upholding Novartis\u2019 U.S. Patent No. 9,187,405. 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","protected":false},"author":109908,"featured_media":151499,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[7202,82,228,3,38597,37020,586],"tags":[358,553,8730,5834,49,970,5758,33,107,8742],"yst_prominent_words":[17777,37532,15340,57151,15347,42504,19120,29172],"acf":[],"_links":{"self":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/posts\/151498"}],"collection":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/users\/109908"}],"replies":[{"embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/comments?post=151498"}],"version-history":[{"count":0,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/posts\/151498\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/media\/151499"}],"wp:attachment":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/media?parent=151498"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/categories?post=151498"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/tags?post=151498"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/yst_prominent_words?post=151498"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}