{"id":768,"date":"2020-09-23T00:54:34","date_gmt":"2020-09-23T00:54:34","guid":{"rendered":"http:\/\/www.chinaiplawupdate.com\/?p=768"},"modified":"2021-03-08T05:03:39","modified_gmt":"2021-03-08T05:03:39","slug":"china-introduces-proposed-patent-linkage-system-for-comment","status":"publish","type":"post","link":"https:\/\/www.chinaiplawupdate.com\/2020\/09\/china-introduces-proposed-patent-linkage-system-for-comment\/","title":{"rendered":"China Introduces Proposed Patent Linkage System for Comment"},"content":{"rendered":"<p>On September 11, 2020, China’s \u00a0<a href=\"https:\/\/www.nmpa.gov.cn\/index.html\">National Medical Products Administration<\/a> (NMPA) and the <a href=\"http:\/\/www.cnipa.gov.cn\">China National Intellectual Property Administration<\/a> (CNIPA) jointly issued the draft Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions) (<a href=\"https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/qtggtg\/20200911175627186.html\">\u836f\u54c1\u4e13\u5229\u7ea0\u7eb7\u65e9\u671f\u89e3\u51b3\u673a\u5236\u5b9e\u65bd\u529e\u6cd5\uff08\u8bd5\u884c)( \u5f81\u6c42\u610f\u89c1\u7a3f)<\/a>).\u00a0 Patent linkage refers to the process by which a country links drug marketing authorization to the status of the patent(s) corresponding to the originator\u2019s product. Typically, marketing authorization for a generic drug will not be granted prior to the expiration of the patent on the branded equivalent, or until the relevant authority has determined that the branded drug\u2019s patent will not be infringed or is invalid.<!--more--><\/p>\n<p>Some of the highlights include:<\/p>\n<p><span style=\"text-decoration: underline;\">Establishment of an “Orange Book”<\/span><\/p>\n<p>Similar to the U.S.’ orange book, the draft proposes establishment of an information disclosure platform for patentees to list drug-related patent information.\u00a0 Specifically, when applying for a listing, applicants should provide: <span><span class=\"\">\u00a0drug name, related\u00a0<\/span><\/span><span><span class=\"\">patent number, patent\u00a0<\/span><\/span><span><span class=\"\">type\u00a0<\/span><\/span><span><span class=\"\">,\u00a0<\/span><\/span><span><span class=\"\">patent status, <\/span><\/span><span><span class=\"\">patentee,\u00a0<\/span><\/span><span><span class=\"\">marketing license holder,\u00a0<\/span><\/span><span><span class=\"\">expiration date\u00a0 of patent <\/span><\/span><span><span class=\"\">protection\u00a0<\/span><\/span><span><span class=\"\">,\u00a0<\/span><\/span><span><span class=\"\">correspondence address, contact person, contact information,\u00a0<\/span><\/span><span><span class=\"\">etc. Patents that can be listed include those for Active Pharmaceutical Ingredients (APIs), compositions containing APIs, formulations, biologics (sequence structure patent) and Traditional Chinese Medicine.<\/span><\/span><\/p>\n<p>The platform must be updated within 30 days of any changes (e.g., in patent status).<\/p>\n<p><span style=\"text-decoration: underline;\">Generic Certifications<\/span><\/p>\n<p>Generic manufacturers must submit one of the following statements when seeking marketing authorization:<\/p>\n<ol>\n<li>Type I Certification: No relevant patent is listed on the platform.<\/li>\n<li>Type II Certification: The relevant listed patent has expired or was invalidated.<\/li>\n<li>Type III Certification: The generic drug will not enter the market before the expiration of the relevant listed patent.<\/li>\n<li>Type IV Certification: The generic manufacturer believes the relevant listed patent to be invalid or not infringed.<\/li>\n<\/ol>\n<p><span style=\"text-decoration: underline;\">Patentee Response to Certification Statement<\/span><\/p>\n<p>Within 45 days of publication of a generic certification a patentee or interested party can file a lawsuit or administrative complaint with CNIPA and must submit a case acceptance within 10 days of the case acceptance date.\u00a0 This will generate a 9-month moratorium on giving marketing authorization to the generic but will not halt the evaluation for marketing authorization.\u00a0 If the patentee cannot get a favorable ruling from a Court or CNIPA within 9 months, the NMPA can grant marketing authorization for the generic.<\/p>\n<p><span style=\"text-decoration: underline;\">Marketing Exclusivity<\/span><\/p>\n<p>The first generic applicant that successfully challenges patent validity will enjoy a 12-month exclusivity period.\u00a0<\/p>\n<p><span style=\"text-decoration: underline;\">Remedies<\/span><\/p>\n<p>After a generic drug is approved for marketing, a patentee may still sue a generic manufacturer for patent infringement. However, marketing authorization will not be withdrawn.<\/p>\n<p><span style=\"text-decoration: underline;\">Submitting Comments<\/span><\/p>\n<p>Comments are due by October 25, 2020 and can be submitted by email to swzpc@nmpa.gov.cn using this <a href=\"https:\/\/www.nmpa.gov.cn\/directory\/web\/nmpa\/images\/1599818313174095384.doc\">feedback form<\/a>.\u00a0 Those in the pharma space may wish to submit comments to increase the 9-month moratorium.\u00a0 In contrast, the U.S. has a 30-month moratorium and a longer moratorium would provide enough time for a Court to render a decision, especially as litigation involving foreigners often takes longer than with domestic litigants.\u00a0 Further, pharma companies may also recommend requiring the generic manufacturer submitting a statement to notify the patentee of the statement, as is required in the U.S.<\/p>\n","protected":false},"excerpt":{"rendered":"<p class=\"excerpt\">On September 11, 2020, China’s \u00a0National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued the draft Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions) (\u836f\u54c1\u4e13\u5229\u7ea0\u7eb7\u65e9\u671f\u89e3\u51b3\u673a\u5236\u5b9e\u65bd\u529e\u6cd5\uff08\u8bd5\u884c)( \u5f81\u6c42\u610f\u89c1\u7a3f)).\u00a0 Patent linkage refers to the process by which a country links drug marketing authorization to the status of the patent(s) corresponding to the originator\u2019s product. Typically, marketing authorization for a generic drug will not be granted prior to the expiration …<\/p>\n<p class=\"more-link\"><a href=\"https:\/\/www.chinaiplawupdate.com\/2020\/09\/china-introduces-proposed-patent-linkage-system-for-comment\/\" class=\"button\">Continue Reading<\/a><\/p>","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7,5],"tags":[],"coauthors":[22],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>China Introduces Proposed Patent Linkage System for Comment - China IP Law Update<\/title>\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.chinaiplawupdate.com\/2020\/09\/china-introduces-proposed-patent-linkage-system-for-comment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"China Introduces Proposed Patent Linkage System for Comment - China IP Law Update\" \/>\n<meta property=\"og:description\" content=\"On September 11, 2020, China’s \u00a0National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued the draft Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions) (\u836f\u54c1\u4e13\u5229\u7ea0\u7eb7\u65e9\u671f\u89e3\u51b3\u673a\u5236\u5b9e\u65bd\u529e\u6cd5\uff08\u8bd5\u884c)( \u5f81\u6c42\u610f\u89c1\u7a3f)).\u00a0 Patent linkage refers to the process by which a country links drug marketing authorization to the status of the patent(s) corresponding to the originator\u2019s product. 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