{"id":15974,"date":"2023-07-20T12:12:00","date_gmt":"2023-07-20T04:12:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15974"},"modified":"2024-12-01T12:47:01","modified_gmt":"2024-12-01T04:47:01","slug":"sichuan-gowell-pharmaceutical-wins-reversal-in-forxiga-patent-infringement-case","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15974","title":{"rendered":"Sichuan Gowell Pharmaceutical Wins Reversal in Forxiga Patent Infringement Case"},"content":{"rendered":"\n<p>Sichuan Gowell Pharmaceutical Co., Ltd. has secured a favorable final judgment in its appeal against the assertion that its generic version of AstraZeneca&#8217;s (AZ, <a href=\"https:\/\/www.google.com\/finance\/quote\/AZN:NASDAQ\">NASDAQ: AZN<\/a>) type 2 diabetes therapy, Forxiga (dapagliflozin), infringed upon a patent listed by AstraZeneca on the Center for Drug Evaluation (CDE)&#8217;s drug patent registration platform, known as China&#8217;s Orange Book. On June 14, 2023, the Supreme People&#8217;s Court overturned the original judgment, confirming that AstraZeneca&#8217;s patent No. 200780024135.X was not valid for use in a patent linkage case, effectively upholding Gowell&#8217;s appeal after the Center for Intellectual Property Administration (CNIPA) had initially ruled in favor of AstraZeneca.<\/p>\n\n\n\n<p><strong>Forxiga&#8217;s Market Position and Generic Competition in China<\/strong><br>Forxiga (dapagliflozin), the first SGLT2 inhibitor approved in China for the management of type 2 diabetes in March 2017, expanded its indications in February 2021 to include the treatment of adult heart failure with reduced ejection fraction (HFrEF, NYHA Class II-IV) and to mitigate the risk of cardiovascular death and hospitalization for heart failure. The drug has been covered by national reimbursement since 2019. Winsunny Pharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/601089:SHA\">SHA: 601089<\/a>) and Lukang Pharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/600789:SHA\">SHA: 600789<\/a>) received approval for two generic versions in October 2021, with SL Pharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/002038:SHE\">SHE: 002038<\/a>) and Hansoh Pharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/3692:HKG\">HKG: 3692<\/a>) following suit in 2023.<\/p>\n\n\n\n<p><strong>Patent Linkage System and Generic Challenges in China<\/strong><br>The drug patent linkage system in China, which officially commenced on July 5, 2021, saw dapagliflozin become the most contested drug by generic firms with Category 4 declarations. To date, 31 Category 4.1 or 4.2 declarations have been lodged against dapagliflozin. Hansoh Pharma filed a Category 4.2 patent declaration on July 23, 2021, which was deemed distinct from the originator patent. Gowell Pharma filed a Category 4.1 declaration on November 29, 2021, challenging the validity of three patents: CN2008800169027, CN201210201489X, and CN200780024135X. Specifically, regarding the CN200780024135X patent, Gowell Pharma argued that claim 9, which is essentially a crystalline patent, should not be registered on the China&#8217;s Orange Book website, https:\/\/zldj.cde.org.cn. The patent faced three invalidation requests (4W112609, 4W113508, 4W113616), all of which have been closed without affecting the validity of the registered claims.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Gowell Pharmaceutical Co., Ltd. has secured a favorable final judgment in its appeal against&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,61],"tags":[39,2513,363,1182,2516,871,73,2515,2076,2077,2514],"class_list":["post-15974","post","type-post","status-publish","format-standard","hentry","category-company","category-legal-ip","tag-diabetes","tag-gowell-pharmaceutical","tag-hansoh-pharmaceutical","tag-hkg-3692","tag-lukang-pharmaceutical","tag-nasdaq-azn","tag-patents","tag-sha-601089","tag-she-002038","tag-sl-pharmaceutical","tag-winsunny-pharma"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sichuan Gowell Pharmaceutical Wins Reversal in Forxiga Patent Infringement Case - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Gowell Pharmaceutical Co., Ltd. has secured a favorable final judgment in its appeal against the assertion that its generic version of AstraZeneca&#039;s (AZ, NASDAQ: AZN) type 2 diabetes therapy, Forxiga (dapagliflozin), infringed upon a patent listed by AstraZeneca on the Center for Drug Evaluation (CDE)&#039;s drug patent registration platform, known as China&#039;s Orange Book. On June 14, 2023, the Supreme People&#039;s Court overturned the original judgment, confirming that AstraZeneca&#039;s patent No. 200780024135.X was not valid for use in a patent linkage case, effectively upholding Gowell&#039;s appeal after the Center for Intellectual Property Administration (CNIPA) had initially ruled in favor of AstraZeneca.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=15974\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sichuan Gowell Pharmaceutical Wins Reversal in Forxiga Patent Infringement Case\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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