{"id":5715,"date":"2022-10-31T15:46:26","date_gmt":"2022-10-31T19:46:26","guid":{"rendered":"https:\/\/www.ktslaw.com.cn\/?p=5715"},"modified":"2023-02-23T20:15:01","modified_gmt":"2023-02-24T01:15:01","slug":"the-sound-of-silence-take-two","status":"publish","type":"post","link":"https:\/\/www.ktslaw.com.cn\/en\/the-sound-of-silence-take-two\/","title":{"rendered":"The Sound of Silence: Take Two"},"content":{"rendered":"

By: Allison W. Dobson, Ph.D.<\/strong><\/a>\u00a0and Alexandra Farquhar, Ph.D.*<\/strong><\/p>\n

In claiming a negative limitation, where the specification is silent as to that limitation, the written description requirement for support is a showing of inherency.\u00a0 So says a June 2022 split decision of the re-constituted panel of the Federal Circuit Court of Appeals on rehearing and reversal of Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.<\/em>\u00a0 Judge O\u2019Malley, who wrote the original Federal Circuit decision (also split) in January 2022, retired in March and was replaced with Judge Hughes for this appeal.\u00a0 On rehearing, Chief Judge Moore wrote the majority opinion invalidating the patent, with Judge Hughes joining her and Judge Linn dissenting.<\/p>\n

The Novartis<\/em> patent claim includes a negative limitation: \u201cabsent an immediately preceding loading dose regimen.\u201d\u00a0 In the first decision in January, which we previously reviewed here, the Federal Circuit held that the negative limitation is supported by the as-filed specification, even though the specification does not mention a loading dose or the absence thereof.\u00a0 The decision penned by O\u2019Malley stated that implicit<\/em> disclosure of the subject matter was sufficient for written description support and relied on a prophetic example to provide that support.<\/p>\n

However, on rehearing the decision penned by Chief Judge Moore found that the loading dose limitation lacked written description support.\u00a0 Implicit<\/em> disclosure of a negative claim limitation is not sufficient and instead express or inherent<\/em> disclosure is required.\u00a0 In order to show sufficient support, the negative limitation must be \u201cnecessarily excluded\u201d from the viewpoint of a skilled artisan reading the disclosure.<\/p>\n

The reversal decision holds the Novartis patent invalid for lack of written description, and Novartis moved to stay the Federal Circuit mandate pending a filing and disposition of a petition a writ of certiorari, which was denied by the Federal Circuit on September 27.\u00a0 Novartis then appealed to Chief Justice John Roberts with an emergency request to stay the Federal Circuit mandate, which he ordered in a rare Supreme Court action on September 29.\u00a0 The Supreme Court vacated that order on October 13. Novartis has not yet filed a petition for writ of certiorari<\/em>.<\/p>\n

*<\/strong>Alexandra Farquhar, Ph.D. is a Law Clerk at Kilpatrick, Townsend & Stockton, LLP.<\/p>\n","protected":false},"excerpt":{"rendered":"

By: Allison W. Dobson, Ph.D.\u00a0and Alexandra Farquhar, Ph.D.* In claiming a negative limitation, where the specification is silent as to that limitation, the written description requirement for support is a showing of inherency.\u00a0 So says a June 2022 split decision of the re-constituted panel of the Federal Circuit Court of Appeals on rehearing and reversal […]<\/p>\n","protected":false},"author":23,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[105],"tags":[],"class_list":["post-5715","post","type-post","status-publish","format-standard","hentry","category-publication"],"acf":[],"yoast_head":"\nThe Sound of Silence: Take Two - Kilpatrick<\/title>\n<meta name=\"description\" content=\"In claiming a negative limitation, where the specification is silent as to that limitation, the written description requirement for support is a showing of inherency.\u00a0 So says a June 2022 split decision of the re-constituted panel of the Federal Circuit Court of Appeals on rehearing and reversal of Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.\u00a0 Judge O\u2019Malley, who wrote the original Federal Circuit decision (also split) in January 2022, retired in March and was replaced with Judge Hughes for this appeal.\u00a0 On rehearing, Chief Judge Moore wrote the majority opinion invalidating the patent, with Judge Hughes joining her and Judge Linn dissenting.\u00a0\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ktslaw.com.cn\/en\/the-sound-of-silence-take-two\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Sound of Silence: Take Two - Kilpatrick\" \/>\n<meta property=\"og:description\" content=\"In claiming a negative limitation, where the specification is silent as to that limitation, the written description requirement for support is a showing of inherency.\u00a0 So says a June 2022 split decision of the re-constituted panel of the Federal Circuit Court of Appeals on rehearing and reversal of Novartis Pharmaceuticals Corp. v. 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