{"id":2027,"date":"2017-04-04T12:05:31","date_gmt":"2017-04-04T12:05:31","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2027"},"modified":"2021-07-24T12:56:43","modified_gmt":"2021-07-24T07:26:43","slug":"notizia-33","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-33","title":{"rendered":"Biogen triumphs; Lilly, Pfizer, Ipsen back; Court nixes; Mylan EpiPen recall"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69d70c3c11af9\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69d70c3c11af9\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-33\/#Biogen_triumphs_in_latest_Tecfidera_patent_dispute\" >Biogen triumphs in latest Tecfidera patent dispute<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-33\/#Lilly_Pfizer_Ipsen_back_Sanofi_and_Regeneron_in_PCSK9_patent_appeal_AbbVie_doesnt\" >Lilly, Pfizer, Ipsen back Sanofi and Regeneron in PCSK9 patent appeal, AbbVie doesn&#8217;t<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-33\/#Court_nixes_Acorda_patents_teeing_up_Ampyra_generics\" >Court nixes Acorda patents, teeing up Ampyra generics<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-33\/#Mylan_EpiPen_recall_goes_global_but_company_says_it_has_plenty_of_replacements\" >Mylan EpiPen recall goes global but company says it has plenty of replacements<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Biogen_triumphs_in_latest_Tecfidera_patent_dispute\"><\/span>Biogen triumphs in latest Tecfidera patent dispute<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Biogen has prevailed in a patent squabble with Denmark\u2019s Forward Pharma over multiple sclerosis med Tecfidera\u2014but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward could not declare patent infringement by Biogen. The verdict kept Biogen\u2019s Tecfidera IP intact and secured exclusivity through 2028. It\u2019s an outcome that is worth about $5 of upside to Biogen\u2019s stock. In January, Biogen hedged the outcome of the Forward challenge by agreeing to a $1.25 billion settlement with the Danish pharma. The deal would have allowed it to license Forward&#8217;s IP to shield Tecfidera had the PTAB ruling not gone its way. But now that its own IP shield can stay, Biogen will not need to use Forward\u2019s IP, and it also will not owe a royalty contingent for that settlement worth 10% of U.S. sales.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Lilly_Pfizer_Ipsen_back_Sanofi_and_Regeneron_in_PCSK9_patent_appeal_AbbVie_doesnt\"><\/span>Lilly, Pfizer, Ipsen back Sanofi and Regeneron in PCSK9 patent appeal, AbbVie doesn&#8217;t<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Big Pharma is enthralled with the Amgen vs. Sanofi patent fight, as its outcome could affect their in-development meds. Amgen, which makes the cholesterol-fighting Repatha, is asserting an antibody patent that, if upheld, could give the California biotech the power to push Sanofi and Regeneron\u2019s rival PCSK9 drug off the market. And it\u2019s a type of patent that has the potential to allow Amgen\u2014and other drugmakers in other fields\u2014to stake out a claim to an entire class of therapies, or so Sanofi\u2019s legal team said in a recent phone conference with reporters. And that\u2019s why drugmakers have been weighing in with amicus curiae briefs at the U.S. Appeals Court for the Federal Circuit, which hears all patent appeals\u2014Pfizer, Eli Lilly and Ipsen among them. The lone outlier, at least so far is AbbVie. AbbVie\u2019s brief contends that antibodies are expensive to develop, and without strong patent protections that limit competition, wouldn\u2019t be worth the expense. Patent protection may mean drugs cost more in the short run, but that\u2019s the price of developing new and complex biologic treatments, the brief states.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Court_nixes_Acorda_patents_teeing_up_Ampyra_generics\"><\/span>Court nixes Acorda patents, teeing up Ampyra generics<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Acorda Therapeutics\u2019 IP protection on Ampyra may have held up against pharma patent challenger Kyle Bass at the U.S. Patent and Trademark Office, but it didn&#8217;t do the same in court. A U.S. District Court stamped out four of the company&#8217;s five patents on the med for multiple sclerosis patients, dubbing them invalid on the grounds of obviousness. It kept just one\u2014a sustained-release patent set to expire in mid-2018\u2014meaning generic competition in 2018 is \u201crealistic,\u201d Leerink Partners analyst Paul Matteis wrote in a note to clients. Ardsley, NY-based Acorda, unsurprisingly, plans to appeal the decision, but it\u2019s not going to sit back and wait for an about-face in court. The company has developed contingency plans for early Ampyra generics, and it &#8220;will provide an update after finalizing the implementation timeline\u201d.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Mylan_EpiPen_recall_goes_global_but_company_says_it_has_plenty_of_replacements\"><\/span>Mylan EpiPen recall goes global but company says it has plenty of replacements<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A recall of potentially malfunctioning EpiPens that Mylan first announced for Europe, Japan and Asia has now gone global, including the U.S., with the company retrieving tens of thousands more. Mylan, however, says it has plenty of replacements to avoid any interruptions in supply. The drugmaker announced the expanded recall of late Friday after the markets closed. According to the FDA, Mylan is voluntarily recalling the 0.3 mg and 0.15 mg strengths of EpiPen and EpiPen Jr. Auto-Injector because of a problem that may keep them from activating. The recall does not include any of its Mylan\u2019s new authorized generic EpiPens. The first recall was for Japan, Australia and some markets in Europe. Now it has been expanded to the U.S. as well as additional markets in Europe, Asia and North and South America.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Biogen triumphs in latest Tecfidera patent dispute Biogen has prevailed in a patent squabble with Denmark\u2019s Forward Pharma over multiple sclerosis med Tecfidera\u2014but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward could not declare patent infringement by Biogen. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1712,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[56,831,830,1497,412,420,712,17500],"industry":[17225],"therapeutic_areas":[17229,17240,17245],"class_list":["post-2027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-abbvie","tag-amgen","tag-biogen","tag-multiple-sclerosis","tag-mylan","tag-news","tag-pharma-industry","tag-sclerosis","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">AbbVie<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Amgen<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Biogen<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Multiple Sclerosis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Mylan<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pharma Industry<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Sclerosis<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">AbbVie<\/span>","<span class=\"advgb-post-tax-term\">Amgen<\/span>","<span class=\"advgb-post-tax-term\">Biogen<\/span>","<span class=\"advgb-post-tax-term\">Multiple Sclerosis<\/span>","<span class=\"advgb-post-tax-term\">Mylan<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Pharma Industry<\/span>","<span class=\"advgb-post-tax-term\">Sclerosis<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Apr 4, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Apr 4, 2017 12:05 pm","modified":"Updated on Jul 24, 2021 12:56 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