{"id":403,"date":"2024-04-26T13:20:00","date_gmt":"2024-04-26T13:20:00","guid":{"rendered":"https:\/\/ipfray.com\/?p=403"},"modified":"2024-04-26T13:20:00","modified_gmt":"2024-04-26T13:20:00","slug":"glaxosmithkline-sues-pfizer-biontech-in-district-of-delaware-over-mrna-patents-allegedly-infringed-by-covid-vaccine","status":"publish","type":"post","link":"https:\/\/ipfray.com\/staging1\/glaxosmithkline-sues-pfizer-biontech-in-district-of-delaware-over-mrna-patents-allegedly-infringed-by-covid-vaccine\/","title":{"rendered":"GlaxoSmithKline sues Pfizer, BioNTech in District of Delaware over mRNA patents allegedly infringed by COVID vaccine"},"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=\"wp-block-paragraph\"><strong>Context:<\/strong> Lawsuits over mRNA patents allegedly infringed by COVID-19 vaccines have previously been brought, most notably by Moderna and CureVac, rather unsuccessfully so far.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>What&#8217;s new:<\/strong> With GlaxoSmithKline, one of the world&#8217;s largest pharmaceutical companies has now thrown its hat in the ring. GSK is suing Pfizer and BioNTech over the latter&#8217;s COVID-19 vaccine in the District of Delaware, seeking damages for the alleged infringement of five patents.<\/p>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Here&#8217;s the complaint:<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-rich is-provider-documentcloud wp-block-embed-documentcloud\"><div class=\"wp-block-embed__wrapper\">\n<span class=\"NpAZLEXuFfYsnMecDBO5Ko1h2gUk0V4J9HCIRjr6ib3PaGz7dxTSqywvtm8Wl\"><iframe loading=\"lazy\" title=\"24-04-25 GSK v. Pfizer at al. D.Del. 1-24cv512 complaint (Hosted by DocumentCloud)\" src=\"https:\/\/embed.documentcloud.org\/documents\/24614246-24-04-25-gsk-v-pfizer-at-al-ddel-1-24cv512-complaint\/?embed=1&amp;title=1\" width=\"500\" height=\"750\" style=\"border: 1px solid #aaa;\" sandbox=\"allow-scripts allow-same-origin allow-popups allow-forms allow-popups-to-escape-sandbox\"><\/iframe><\/span>\n<\/div><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">It&#8217;s unclear why GSK waited so long to bring its claims. The company may have deemed it prudent to await developments in other litigations involving COVID-19 vaccines in general and BioNTech&#8217;s Cominaty in particular, and\/or it may have wanted to wait for political reasons.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">These are the five patents-in-suit:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11638693B2\/en?oq=11%2c638%2c693\">U.S. Patent No. 11,638,693<\/a> on a &#8220;vaccine for eliciting immune response comprising RNA encoding an immunogen and lipid formulations comprising mole percentage of lipids&#8221;<\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11638694B2\/en?oq=11%2c638%2c694\">U.S. Patent No. 11,638,694<\/a> on  a &#8220;vaccine for eliciting immune response comprising lipid formulations and RNA encoding multiple immunogens&#8221;<\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11666534B2\/en?oq=11%2c666%2c534\">U.S. Patent No. 11,666,534<\/a> on &#8220;methods of administering lipid formulations with viral immunogens&#8221;<\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11766401B2\/en?oq=11%2c766%2c401\">U.S. Patent No. 11,766,401<\/a> on &#8220;methods of administering lipid formulations with immunogens&#8221;<\/li>\n\n\n\n<li class=\"\"><a href=\"https:\/\/patents.google.com\/patent\/US11786467B2\/en?oq=11%2c786%2c467\">U.S. Patent No. 11,786,467<\/a> on &#8220;lipid formulations with immunogens&#8221;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This is what the complaint says about the history of GSK&#8217;s innovation in mRNA:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">2. In 2008, more than a decade before the SARS-CoV-2 (2019) coronavirus disease (COVID-19) pandemic, Andrew Geall, an accomplished formulation scientist and the named  inventor of the Patents-in-Suit, joined a team of talented researchers working under the leadership of vaccinologist Christian Mandl (the \u201cMandl team\u201d) focused on developing mRNA vaccines. These individuals discovered formulations comprising lipids and mRNA molecules encoding a viral immunogen that provide protection from viral infection. The Mandl team described the inventions now claimed in the Patents-in-Suit, in patent applications filed in 2010.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. The Mandl team\u2019s innovation has been revolutionary for vaccine development. A significant advantage over other approaches to vaccine design is the ability to employ the technology as a platform to formulate and administer mRNA encoding a wide range of immunogens. The prestigious science journal <em>Nature <\/em>noted in 2021 that \u201c[e]very mRNA company now uses some variation of [the Mandl team\u2019s] delivery platform and manufacturing system[.]\u201d Exhibit 6 (Dolgin, \u201cThe Tangled History of mRNA Vaccines,\u201d <em>Nature<\/em> 597, 318 (2021)) at 323.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Another major advance of the Mandl team\u2019s inventions over preexisting vaccine technologies is the speed with which a new vaccine candidate can be made and tested. Indeed, in response to the 2013 influenza outbreak in China, the Mandl team created a new mRNA vaccine candidate in just eight days\u2014\u201cin real time the moment that sequence was available.\u201d Exhibit 7 (Dolgin, \u201cInjection of Hope,\u201d <em>Nature<\/em> 574, S10 (2019)) at S11. <em>Nature <\/em>recognized this achievement as \u201c[t]he current speed record\u201d of vaccine development. <em>Id.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">This is obviously a multi-billion-dollar case. GSK is being represented by local Delaware law firm <a href=\"https:\/\/www.rlf.com\/\">Richards, Layton &amp; Finger<\/a>, with most of the work apparently being done by <a href=\"https:\/\/www.desmaraisllp.com\/\">Desmarais<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>GlaxoSmithKline, one of the world&#8217;s largest pharmaceutical companies, is suing Pfizer and BioNTech in the District of Delaware, alleging that their COVID-19 vaccines infringe GSK&#8217;s mRNA patents.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[12,79],"tags":[],"class_list":["post-403","post","type-post","status-publish","format-standard","hentry","category-patent-litigation","category-pharmaceutical-industry"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/403","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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/comments?post=403"}],"version-history":[{"count":1,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/403\/revisions"}],"predecessor-version":[{"id":404,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/403\/revisions\/404"}],"wp:attachment":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/media?parent=403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/categories?post=403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/tags?post=403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}