{"id":1410,"date":"2025-01-09T10:11:39","date_gmt":"2025-01-09T10:11:39","guid":{"rendered":"https:\/\/ipfray.com\/?p=1410"},"modified":"2025-01-09T10:11:39","modified_gmt":"2025-01-09T10:11:39","slug":"catalyst-and-teva-pharmaceuticals-settle-patent-dispute-over-rare-disease-drug-but-fight-for-orphan-treatment-not-over-yet","status":"publish","type":"post","link":"https:\/\/ipfray.com\/staging1\/catalyst-and-teva-pharmaceuticals-settle-patent-dispute-over-rare-disease-drug-but-fight-for-orphan-treatment-not-over-yet\/","title":{"rendered":"Catalyst and Teva Pharmaceuticals settle patent dispute over rare-disease drug, but fight for orphan treatment not over yet"},"content":{"rendered":"\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px\">\n<p class=\"\"><strong>Context:<\/strong> In January 2023, Teva Pharmaceuticals Ltd. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for a generic version of Firdapse in the U.S., ahead of the expiration of Catalyst Pharmaceuticals Inc.\u2019s patents covering the drug in February 2037. In a notice letter to Catalyst, Teva alleged that those patents were invalid, unenforceable, and\/or would not be infringed. In March 2023, Catalyst launched a patent dispute against Teva in the United States District Court for the District of New Jersey, alleging that its ANDA \u2013 if approved \u2013 would infringe on six Firdapse-related patents that it is currently licensing from Serb Pharmaceuticals S.A. Firdapse is a drug used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare auto-immune disease which impacts the signals sent from the nerves to the body\u2019s muscles and causes weakness in the limbs. In 2024, Firdapse generated a net product revenue of over US$79 million \u2013 a 19.7% increase on the total revenue in 2023. In April 2023, it emerged that Catalyst was also suing Lupin Ltd. and Hetero Labs Ltd. (as well as its subsidiaries Annora Pharma Private Ltd. and Grace Consulting Services Inc.) for infringing the same six patents.<\/p>\n\n\n\n<p class=\"\"><strong>What\u2019s new: <\/strong>Catalyst has settled its patent dispute with Teva, granting the latter a license to market Firdapse \u2013 subject to the FDA\u2019s approval \u2013 no earlier than February 2035. The agreement is subject to review by the U.S. Federal Trade Commission (FTC) and Department of Justice (DOJ) (<a href=\"https:\/\/ir.catalystpharma.com\/news-releases\/news-release-details\/catalyst-pharmaceuticals-announces-settlement-firdapser\">January 8, 2025 Catalyst press release<\/a>).<\/p>\n\n\n\n<p class=\"\"><strong>Direct impact:<\/strong> Since announcing the settlement, Catalyst\u2019s shares have gone up by 18%. This outcome comes in above expectations, according to analyst firm <a href=\"https:\/\/www.oppenheimer.com\/index.aspx\">Oppenheimer &amp; Co.<\/a> The firm added: \u201cUncertainty around this topic had kept many on the sidelines and today\u2019s update will facilitate investor interest in [Catalyst].\u201d<\/p>\n\n\n\n<p class=\"\"><strong>Wider ramifications: <\/strong>The settlement is certainly a major boost for Catalyst\u2019s Firdapse. However, the company is still embroiled in patent litigation over the drug with Hetero and Lupin. Only once those are concluded can we safely say Catalyst&#8217;s fight for Firdapse&#8217;s market protection will finally be over.<\/p>\n<\/div>\n\n\n\n<p class=\"\">Florida-based Catalyst is a biopharmaceutical company focused on the treatment of rare diseases. Firdapse is one of its flagship drugs. Israeli Teva is a generic drugmaker. It is currently also embroiled in patent litigation with AstraZeneca over a diabetes drug in the UK.<\/p>\n\n\n\n<p class=\"\">The patents in this Catalyst dispute included:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US10626088B2\/en?oq=10%2c626%2c088\">US Patent No. 10,626,088<\/a> (\u201cDetermining degradation of 3,4-diaminopyridine\u201d)<\/li>\n<\/ul>\n\n\n\n<p class=\"\">As well as the following (which all bear the same title, \u201cmethods of administering 3,4-diaminopyridine\u201d):<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US10793893B2\/en?oq=10%2c793%2c893\">US Patent No. 10,793,893<\/a><\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11060128B2\/en?oq=11%2c060%2c128\">US Patent No. 11,060,128<\/a><\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11268128B2\/en?oq=11%2c268%2c128\">US Patent No. 11,268,128<\/a><\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11274331B2\/en?oq=11%2c274%2c331\">US Patent No. 11,274,331<\/a><\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11274332B2\/en?oq=11%2c274%2c332\">US Patent No. 11,274,332<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"\">Lead attorney for Catalyst was Dennies Varughese, Pharm.D. at <a href=\"https:\/\/www.sternekessler.com\/\">Sterne Kessler Goldstein and Fox<\/a>. Charles H. Chevalier and Christine A. Gaddis at <a href=\"https:\/\/www.gibbonslaw.com\/\">Gibbons P.C.<\/a> also represented the plaintiff. Meanwhile, Teva was represented by Douglas R. Weider at <a href=\"https:\/\/www.gtlaw.com\/en\/\">Greenberg Traurig<\/a>.<\/p>\n\n\n\n<p class=\"\">In a statement yesterday, Catalyst\u2019s Co-Founder and Chairman Patrick McEnany said:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"\">\u201cWe are pleased to have reached a resolution with Teva and believe this agreement solidifies Firdapse\u2019s market exclusivity for many more years to come.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p class=\"\">The company has faced challenges over this drug before. After Firdapse was approved by the FDA in 2018, Catalyst was also granted exclusivity through November 2025. However, that same year a U.S. rival, Jacobus Pharmaceutical Company, also filed an NDA for Ruzurgi, another treatment for LEMS. To get around Catalyst\u2019s exclusivity, the FDA separated Jacobus\u2019s NDA into two parts: one for the treatment of LEMS in pediatric patients and the other for adult patients. Catalyst\u2019s drug, on the other hand, is only for patients aged six and above. The FDA stated at the time that Ruzurgi did not breach Catalyst\u2019s exclusivity because \u201cthe approval of the drug for pediatric patients constituted a different \u201cindication or use\u201d from the Firdapse approval for adult patients\u201d.<\/p>\n\n\n\n<p class=\"\">Catalyst later filed a suit against the FDA over this approval, alleging that it violated the \u201csame drug for the same disease or condition\u201d restriction in the Orphan Drug Act. This law mandates that a drug which has officially been designated as a treatment for a rare condition is granted seven years of regulatory exclusivity after it receives FDA approval. During that time, the FDA cannot allow any other company to market the \u201csame drug for the same disease or condition\u201d.<\/p>\n\n\n\n<p class=\"\">This suit was initially dismissed in the Southern District of Florida. But, on appeal, the Court of Appeals for the Eleventh Circuit sided with Catalyst, ruling that the agency\u2019s action was \u201carbitrary, capricious and not in accordance with the law.\u201d That decision set a major precedent for orphan drug exclusivity in the U.S. (<a href=\"https:\/\/media.ca11.uscourts.gov\/opinions\/pub\/files\/202013922.pdf?_sm_au_=iVV1qN1NTQrTfJjjvMFckK0232C0F\">September 30, 2021 11th Circuit ruling<\/a>).<\/p>\n\n\n\n<p class=\"\">Jacobus then filed a petition for a writ of certiorari (request for Supreme Court review) but that was <a href=\"https:\/\/www.justice.gov\/jmd\/media\/1235631\/dl?inline\">denied in July 2022<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nasadaq-listed Catalyst sees shares rise by 18% following the settlement, which grants Teva a license from February 2035.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[27,12,14,79],"tags":[],"class_list":["post-1410","post","type-post","status-publish","format-standard","hentry","category-ip-license-agreements","category-patent-litigation","category-patents","category-pharmaceutical-industry"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/1410","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/comments?post=1410"}],"version-history":[{"count":16,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/1410\/revisions"}],"predecessor-version":[{"id":1428,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/1410\/revisions\/1428"}],"wp:attachment":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/media?parent=1410"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/categories?post=1410"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/tags?post=1410"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}