{"id":3973,"date":"2018-04-27T10:30:00","date_gmt":"2018-04-27T09:30:00","guid":{"rendered":"http:\/\/klunker-ip.com\/proof-of-lack-of-support-for-broad-claims-amgen-v-sanofi-cafc\/"},"modified":"2025-11-01T14:43:12","modified_gmt":"2025-11-01T13:43:12","slug":"proof-of-lack-of-support-for-broad-claims-amgen-v-sanofi-cafc","status":"publish","type":"post","link":"https:\/\/klunker-ip.com\/en\/proof-of-lack-of-support-for-broad-claims-amgen-v-sanofi-cafc\/","title":{"rendered":"Proof of lack of support for broad claims (Amgen v. Sanofi – CAFC)"},"content":{"rendered":"\n

Broad claims must be supported by a representative number of examples. The skilled person should be able to carry out the invention on the priority date. Evidence to show whether the skilled person could carry out the invention based on the prior art must predate the priority date. A US court of first instance had therefore rejected the evidence that only arose after the priority date on principle. The Court of Appeal made a more differentiated decision. <\/strong><\/p>\n\n

Amgen began studying PCSK9 inhibitors in 2005 to develop a new treatment for high cholesterol levels. On January 9, 2008, Amgen filed a Patent Application for a monoclonal antibody and received two Patents in 2014. The corresponding drug Repatha\u2122 was launched on the market in 2015. <\/p>\n\n

The patent claim is very broadly directed to a monoclonal antibody which, on the one hand, binds to a larger number of specifically named residues and, on the other hand, blocks the binding of PCSK9 to LDL-R.<\/p>\n\n

The patent description describes a trial-and-error method that Amgen used to generate certain antibodies and then test their function (screening). According to the patent description, 3000 human monoclonal antibodies have been screened for the desired function using this method, resulting in 85 functioning specimens. For two of these embodiments, the antibodies have been described on the basis of their three-dimensional structure. One of these two antibodies is used in the drug Repatha\u2122. <\/p>\n\n

Sonofi\/Regeneron had started development of the drug Praluent\u2122 in September 2007. They also used the mechanism of preventing PCSK9 from binding and destroying LDL-R proteins. They applied for a patent for their specific solution, which was granted in November 2011. The claim is specifically directed to the active substance used in Praluent and defines its amino acid sequence. <\/p>\n\n

In 2014, Amgen filed a Lawsuit against Sanofi\/Regeneron for patent infringement. While Sanofi acknowledged that Praluent \u2122 fell within Amgen’s claim, it attacked the patent for insufficient disclosure and lack of inventiveness. To prove the lack of disclosure, Sanofi wanted to submit documents from its own research, which had only been carried out after the priority date. <\/p>\n\n

The District Court did not admit into evidence the documents created after the priority date. They would not document the prior art at the priority date and were therefore not relevant to the assessment of sufficiency of disclosure. The court upheld the patent and affirmed infringement. <\/p>\n\n

Sanofi appealed against this to the Court of Appeals for the Federal Circuit (CAFC). The CAFC overturned the first-instance judgment and ordered that the first-instance trial be reopened in order to examine Sanofi’s evidence. <\/p>\n\n

The CAFC explains the reasons as follows:<\/p>\n\n

The legal requirement of sufficient disclosure is intended to ensure that the inventor actually possessed the invention. Ownership is evident from the fact that a “representative number of embodiments falling within the generic term of the claim are disclosed. The “members of the genus … should be visualized and recognizable” for the person skilled in the art. <\/p>\n\n

In the present dispute, the central question is whether evidence and knowledge arising after the priority date may be used to assess whether a “representative number of embodiments” is disclosed.<\/p>\n\n

The CAFC confirms that sufficient disclosure is generally to be assessed on the basis of the state of the art at the priority date.<\/p>\n\n

However, it is also true that the “representative number of examples” of the claimed class can probably only be assessed on the basis of evidence developed after the priority date. If the non-disclosed examples were part of the prior art, the genus could not be claimed at all due to lack of novelty. <\/p>\n\n

In the earlier AbbVie v. Janssen judgment, the functional claim was denied sufficient support because the functional claim covered an embodiment that was clearly different from the examples in the patent in suit. (This different embodiment was precisely the embodiment used by the alleged infringer). In the judgment at the time, it was only clear that the infringing form was after AbbVie’s invention date. Whether the infringing form was before or after the priority date of the Patent Application was not discussed. <\/p>\n\n

The earlier judgment in re Hogan related to the question of whether post- priority evidence should be admitted to prove prior art after the priority date. This was rightly answered in the negative. However, the judgment did not relate to the question under discussion here, namely whether post- priority evidence may be used to assess the “representative number of examples”. <\/p>\n\n

The previous jurisprudence therefore does not preclude the consideration of post-priority evidence to determine the “representative number”. The judgment of the District Court must therefore be set aside and the case referred back to the court of first instance for reassessment. <\/p>\n\n

Note: Attempts are often made to extend protection far beyond the specific invented embodiments by formulating broad functional claims. However, this can lead to the claim as a whole being invalid in the event of a dispute. Therefore, when formulating the Patent Application, care should be taken to ensure that the claim is supported by an appropriate number of different embodiments in the description. <\/p>\n\n

Left: www.cafc.uscourts.gov\/sites\/default\/files\/opinions-orders\/17-1480.Opinion.10-2-2017.1.PDF<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Broad claims must be supported by a representative number of examples. The skilled person should be able to carry out the invention on the priority date. Evidence to show whether the skilled person could carry out the invention based on the prior art must predate the priority date. A US court of first instance had […]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3973","post","type-post","status-publish","format-standard","hentry","category-nicht-kategorisiert"],"acf":[],"_links":{"self":[{"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/posts\/3973","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/comments?post=3973"}],"version-history":[{"count":0,"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/posts\/3973\/revisions"}],"wp:attachment":[{"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/media?parent=3973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/categories?post=3973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/klunker-ip.com\/en\/wp-json\/wp\/v2\/tags?post=3973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}