{"id":2338,"date":"2025-04-04T13:35:00","date_gmt":"2025-04-04T13:35:00","guid":{"rendered":"https:\/\/ipfray.com\/?p=2338"},"modified":"2025-04-21T08:34:37","modified_gmt":"2025-04-21T08:34:37","slug":"gsk-and-pfizer-settle-global-rsv-vaccine-patent-dispute","status":"publish","type":"post","link":"https:\/\/ipfray.com\/staging1\/gsk-and-pfizer-settle-global-rsv-vaccine-patent-dispute\/","title":{"rendered":"GSK and Pfizer settle global RSV vaccine patent dispute"},"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 August 2023, GlaxoSmithKline (GSK) initiated patent infringement actions against Pfizer in both the District of Delaware and the Unified Patent Court (UPC) (<a href=\"https:\/\/www.linkedin.com\/feed\/update\/urn:li:activity:7231221387258957824\/\"><strong>ip fray<\/strong> LinkedIn post<\/a>), alleging that the defendant\u2019s respiratory syncytial virus (RSV) vaccine infringed several of GSK\u2019s patents related to antigen technology. Pfizer denied the allegations and argued that GSK&#8217;s patents were invalid. GSK\u2019s RSV vaccination, also known as Arexvy, is responsible for two-thirds of U.S. RSV shot sales (<a href=\"https:\/\/www.gsk.com\/en-gb\/media\/press-releases\/gsk-makes-a-strong-start-to-2024-with-improving-outlook-for-the-year\/\">May 2024, GSK press release<\/a>). The vaccine helps treat a condition that typically causes cold-like symptoms but can also lead to pneumonia in toddlers and older adults. In a decision last October, and a huge win for Pfizer, the UK High Court invalidated two of GSK\u2019s RSV-related patents, <a href=\"https:\/\/patents.google.com\/patent\/EP3109258B1\/en?oq=EP3109258\">EP3109258<\/a> and <a href=\"https:\/\/patents.google.com\/patent\/EP2222710B1\/en?oq=EP2222710\">EP2222710<\/a>.<\/p>\n\n\n\n<p class=\"\"><strong>What&#8217;s new:<\/strong> GSK and Pfizer have settled their dispute, according to a filing in the District of Delaware. The companies stated in the filing that they would dismiss the case with prejudice, which means it cannot be refiled.<\/p>\n\n\n\n<p class=\"\"><strong>Direct impact and wider ramifications:<\/strong> This filing also brings an end to the parties\u2019 pending litigation in the UPC. However, GSK and Pfizer\u2019s patent infringement dispute over the latter\u2019s COVID-19 vaccine, Comirnaty, is still pending.<\/p>\n<\/div>\n\n\n\n<p class=\"\">This is the stipulation of dismissal:<\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/ipfray.com\/wp-content\/uploads\/2025\/04\/25-04-03-GSK-v.-Pfizer-stipulation-of-dismissal.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 25-04-03 GSK v. Pfizer stipulation of dismissal.\"><\/object><a id=\"wp-block-file--media-32e4f415-e74f-4044-83b7-d0b098e67afe\" href=\"https:\/\/ipfray.com\/wp-content\/uploads\/2025\/04\/25-04-03-GSK-v.-Pfizer-stipulation-of-dismissal.pdf\">25-04-03 GSK v. Pfizer stipulation of dismissal<\/a><a href=\"https:\/\/ipfray.com\/wp-content\/uploads\/2025\/04\/25-04-03-GSK-v.-Pfizer-stipulation-of-dismissal.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-32e4f415-e74f-4044-83b7-d0b098e67afe\">Download<\/a><\/div>\n\n\n\n<p class=\"\">GSK initiated its UPC prong of the dispute last August, by filing an infringement action over <a href=\"https:\/\/patents.google.com\/patent\/EP4183412B1\/en?oq=EP4183412\">EP4183412<\/a> (\u201cRsv f protein compositions and methods for making same\u201d) with the UPC\u2019s Dusseldorf Local Division between the decision by the European Patent Office (EPO) to grant the patent and the official publication of its issuance. Pfizer then filed a revocation action in the UPC\u2019s Milan seat of the Central Division (CD), 9 seconds after midnight on the date on which the grant was (foreseeably) published by the EPO.<\/p>\n\n\n\n<p class=\"\">In a decision issued in December, the Milan CD decided against GSK\u2019s objection to the revocation action and agreed with Pfizer that the infringement filing was premature (<a href=\"https:\/\/ipfray.com\/pfizer-brought-upc-revocation-action-9-seconds-after-midnight-on-grant-date-argues-glaxo-jumped-the-gun-with-infringement-filing\/\">December 13, 2024 <strong>ip fray<\/strong> article<\/a>).<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img data-recalc-dims=\"1\" height=\"929\" width=\"1024\" decoding=\"async\" src=\"https:\/\/i0.wp.com\/ipfray.com\/wp-content\/uploads\/2025\/04\/Screenshot-2025-04-04-at-15.17.56-1024x929.png?resize=1024%2C929&#038;ssl=1\" alt=\"\" class=\"wp-image-2285\"\/><\/figure>\n\n\n\n<p class=\"\">In 2023, Pfizer also sought a so-called \u201cArrow Declaration\u201d from the UK High Court, arguing that the declaration would serve a \u201cuseful purpose\u201d because there was a clear public health interest in having Pfizer\u2019s vaccine made available in the UK. A decision handed down by Judge James Mellor in October sided with Pfizer, allowing the company to continue to market its RSV vaccine in the UK.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Counsel<\/strong><\/h4>\n\n\n\n<p class=\"\">In the U.S., GSK was represented by <a href=\"https:\/\/www.rlf.com\/lawyers\/sara-m-metzler\/\">Sara M. Metzler<\/a>, <a href=\"https:\/\/www.rlf.com\/lawyers\/frederick-l-cottrell-iii\/\">Frederick L. Cottrell III<\/a>, and <a href=\"https:\/\/www.rlf.com\/lawyers\/kelly-e-farnan\/\">Kelly E. Farnan<\/a>, at <a href=\"https:\/\/www.rlf.com\/\">Richards, Layton &amp; Finger, PA<\/a>, while Pfizer was represented by <a href=\"https:\/\/www.morrisnichols.com\/lawyers-megan-e-dellinger\">Megan E. Dellinger<\/a> and <a href=\"https:\/\/www.morrisnichols.com\/lawyers-jeremy-a-tigan\">Jeremy Tigan<\/a> at <a href=\"https:\/\/www.morrisnichols.com\/\">Morris, Nichols, Arsht &amp; Tunnell LLP<\/a>.<\/p>\n\n\n\n<p class=\"\">In the UPC, counsel for GSK was <a href=\"https:\/\/www.twobirds.com\/\">Bird &amp; Bird<\/a>\u2019s <a href=\"https:\/\/www.twobirds.com\/en\/people\/o\/oliver%C2%A0jan-j%C3%BCngst\">Oliver Jan J\u00fcngst<\/a>, <a href=\"https:\/\/www.twobirds.com\/en\/people\/l\/lucas-brons\">Luca Brons<\/a>, <a href=\"https:\/\/www.twobirds.com\/en\/people\/d\/dr-daniela-kinkeldey\">Dr. Daniela Kinkeldey<\/a>, and <a href=\"https:\/\/www.twobirds.com\/en\/people\/d\/dr-anna-schadel\">Dr. Anna Schadel<\/a>, and counsel for Pfizer was <a href=\"https:\/\/www.marks-clerk.com\/\">Marks &amp; Clerk<\/a>\u2019s <a href=\"https:\/\/www.marks-clerk.com\/our-people\/gareth-williams\/\">Gareth Williams<\/a>, and <a href=\"https:\/\/www.cliffordchance.com\/home.html\">Clifford Chance<\/a>\u2019s <a href=\"https:\/\/www.cliffordchance.com\/people_and_places\/people\/partners\/de\/claudia_milbradt.html\">Dr. Claudia Milbradt<\/a> and <a href=\"https:\/\/www.cliffordchance.com\/people_and_places\/people\/partners\/de\/tobias-hessel.html\">Dr. Tobias J. Hessel<\/a>.<\/p>\n\n\n\n<p class=\"\">In the UK, counsel for GSK was a team at <a href=\"https:\/\/gowlingwlg.com\/en\">Gowling<\/a>, including <a href=\"https:\/\/gowlingwlg.com\/en\/people\/paul-inman\">Paul Inman<\/a>, <a href=\"https:\/\/www.torys.com\/en\/people\/evans-huw\">Huw Evans<\/a>, <a href=\"https:\/\/gowlingwlg.com\/en\/people\/christopher-freeth\">Christopher Freeth<\/a>, <a href=\"https:\/\/gowlingwlg.com\/en\/people\/felicity-wade-palmer\">Felicity Wade-Palmer<\/a>, and <a href=\"https:\/\/gowlingwlg.com\/en\/people\/ollie-carpenter\">Ollie Carpenter<\/a>. Pfizer was represented by Marks &amp; Clerk\u2019s <a href=\"https:\/\/www.marks-clerk.com\/our-people\/mike-gilbert\/\">Mike Gilbert<\/a>, <a href=\"https:\/\/www.marks-clerk.com\/our-people\/mcgrath-daniel\/\">Dan McGrath<\/a>, <a href=\"https:\/\/www.marks-clerk.com\/our-people\/marcus-riby-smith\/\">Marcus Riby-Smith<\/a>, <a href=\"https:\/\/www.marks-clerk.com\/our-people\/mari-brace\/\">Mari Brace<\/a>, and <a href=\"https:\/\/www.marks-clerk.com\/our-people\/caitlin-ahern\/\">Caitlin Ahern<\/a>.<\/p>\n\n\n\n<p class=\"\">Last April, GSK also sued Pfizer and BioNTech in the District of Delaware over the latter\u2019s COVID-19 vaccine, Comirnaty, seeking damages for the infringement of five of its patents (<a href=\"https:\/\/ipfray.com\/glaxosmithkline-sues-pfizer-biontech-in-district-of-delaware-over-mrna-patents-allegedly-infringed-by-covid-vaccine\/\">April 26, 2024 <strong>ip fray<\/strong> article<\/a>). That case is still pending.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The companies announced yesterday that their litigation in the U.S., UK and Unified Patent Court has come to an end, although their dispute over COVID-19 vaccine patent infringement is still pending.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[28,12,14,79,54],"tags":[],"class_list":["post-2338","post","type-post","status-publish","format-standard","hentry","category-l-icensors-licensees","category-patent-litigation","category-patents","category-pharmaceutical-industry","category-unified-patent-court"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/2338","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=2338"}],"version-history":[{"count":1,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/2338\/revisions"}],"predecessor-version":[{"id":2339,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/posts\/2338\/revisions\/2339"}],"wp:attachment":[{"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/media?parent=2338"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/categories?post=2338"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ipfray.com\/staging1\/wp-json\/wp\/v2\/tags?post=2338"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}