{"id":1793,"date":"2017-10-05T11:41:04","date_gmt":"2017-10-05T15:41:04","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=1793"},"modified":"2017-11-25T12:28:59","modified_gmt":"2017-11-25T17:28:59","slug":"antigens-dont-describe-antibodies-and-the-value-of-post-priority-date-activity-on-written-description-and-enablement","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=1793","title":{"rendered":"Antigens Don’t Describe Antibodies, and the Value of Post-Priority Date Activity on Written Description and Enablement"},"content":{"rendered":"

In\u00a0Amgen, Inc. v. Sanofi<\/a>, [2017-1480](October 5, 2017), the Federal Circuit found that the district court erred by excluding Appellants\u2019 evidence
\nregarding written description and enablement, and\u00a0improperly instructed the jury on written description, so the Federal Circuit reversed-in-part the judgment below and remanded\u00a0for a new trial on written\u00a0description and enablement (concluding that defendants\/appellants were not\u00a0entitled to JMOL of no written description\u00a0and no enablement.<\/p>\n

The case relates to\u00a0U.S. Patent Nos. 8,829,165 and\u00a08,859,741 on\u00a0 antibodies\u00a0that help reduce low-density lipoprotein cholesterol (LDLC),
\nor \u201cbad cholesterol.\u201d\u00a0 The district court\u00a0\u00a0excluded Appellants\u2019 evidence about antibodies, including\u00a0Appellants\u2019 infringing Praluent, developed after the\u00a0patents\u2019 priority date of January 9, 2008, reasoning that\u00a0because the
\nevidence did not illuminate the state of the art at the\u00a0time of filing,\u201d it was not relevant \u201cto determine whether\u00a0there is sufficient disclosure of the claimed invention.\u201d<\/p>\n

However, the Federal Circuit found that Appellants were not offering
\npost-priority-date evidence to show that Appellees\u2019\u00a0claimed genus is not enabled because of a change in the\u00a0state of the art. Instead, Appellants offered Praluent and\u00a0other post-priority-date antibodies to argue that the
\nclaimed genus fails to disclose a representative number of\u00a0species. As explained above, the use of post-priority-date\u00a0evidence to show that a patent does not disclose a representative\u00a0number of species of a claimed genus is proper.\u00a0It was thus legal error for the district court to categorically
\npreclude all of Appellants\u2019 post-priority-date evidence of\u00a0Praluent and other antibodies. The Federal Circuit reversed\u00a0the district court\u2019s decision and remanded for a new trial on\u00a0written description.<\/p>\n

The Federal Circuit also found district court\u2019s improper\u00a0exclusion of post-priority-date evidence requires a\u00a0new trial on enablement as well. Under the enablement\u00a0requirement, the specification of a patent must teach
\nthose skilled in the art how to make and use the full scope\u00a0of the claimed invention without undue experimentation.\u00a0 Appellants purportedly sought to introduce\u00a0post-priority-date evidence showing that Appellees\u00a0engaged in lengthy and potentially undue experimentation\u00a0to enable the full scope of the claims. Such evidence\u00a0could have been relevant to determining if the claims\u00a0were enabled as of the priority date and should not have
\nbeen excluded simply because it post-dated the claims\u2019\u00a0priority date.<\/p>\n

The Federal Circuit turned to the jury instructions on written description.\u00a0 The Federal Circuit said that the district\u00a0court correctly instructed the jury that in order to satisfy\u00a0the written description requirement, a patentee may\u00a0disclose either a representative number of species falling\u00a0within the scope of the genus or disclose structural features
\ncommon to the members of the genus so that one of\u00a0skill in the art can visualize or recognize the members of\u00a0the genus.\u00a0 However the district court went on to instruct that “the correlation\u00a0between structure and function may also be satisfied\u00a0by the disclosure of a newly characterized antigen\u00a0by its structure, formula, chemical name, or\u00a0physical properties if you find that the level of\u00a0skill and knowledge in the art of antibodies at the
\ntime of filing was such that production of antibodies\u00a0against such an antigen was conventional or\u00a0routine.”\u00a0 The Federal Circuit this instruction was\u00a0not legally sound and is not\u00a0based on any binding precedent.<\/p>\n

The Federal Circuit said that this instruction improperly allowed a jury to find adequate written description merely from a finding of the ability to make and use the invention.\u00a0 The Federal Circuit said that\u00a0an adequate written description must contain enough\u00a0information about the actual makeup of the claimed\u00a0products\u2014\u201ca precise definition, such as by structure,\u00a0formula, chemical name, physical properties, or other\u00a0properties, of species falling within the genus sufficient to\u00a0distinguish the genus from other materials,\u201d which may\u00a0be present in \u201cfunctional\u201d terminology \u201cwhen the art has\u00a0established a correlation between structure and function.\u201d
\nHowever, it is still contested whether the\u00a0that knowledge of the chemical structure of an antigen\u00a0gives the required kind of structure-identifying information\u00a0about the corresponding antibodies.\u00a0\u00a0The Federal Circuit said that Section 112\u00a0requires a \u201cwritten description of the\u00a0invention,” not something that is not the invention.<\/p>\n

The Federal Circuit affirmed the denial of JMOL of lack of written description and enablement, because with the exclusion of post-priority date evidence the record was incomplete to determine whether there is in fact a lack of written description and enablement.\u00a0 The Federal Circuit also affirmed JMOL of non-obviousness, finding that the district court properly excluded the proffered prior art.\u00a0 These references, two PCT applications were filed after the priority date, but claimed priority to provisional applications filed before the priority date.\u00a0 The Federal Circuit noted that appellants\u00a0did not proffer any\u00a0evidence showing that the provisional applications contained\u00a0representative species or common structural
\nelements sufficient to satisfy the written description\u00a0requirement for the monoclonal antibodies claimed in the\u00a0PCT applications.\u00a0\u00a0Similarly, the Federal Circuit noted, Appellants provided no\u00a0evidence that the claims of the PCT applications were\u00a0enabled by the provisional application. Because the\u00a0district court properly excluded the prior art relied upon by appellant, the court\u2019s grant of JMOL of\u00a0non-obviousness was proper.<\/p>\n

Finally, the Federal Circuit vacated the permanent injunction because it vacated the district court’s judgment as to written description and enablement, and was remanding the case for a new trial.<\/p>\n","protected":false},"excerpt":{"rendered":"

In\u00a0Amgen, Inc. v. Sanofi, [2017-1480](October 5, 2017), the Federal Circuit found that the district court erred by excluding Appellants\u2019 evidence regarding written description and enablement, and\u00a0improperly instructed the jury on written description, so the Federal Circuit reversed-in-part the judgment below … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28,60,31],"tags":[],"class_list":["post-1793","post","type-post","status-publish","format-standard","hentry","category-enablement","category-provisional-applications","category-written-description"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1793","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1793"}],"version-history":[{"count":2,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1793\/revisions"}],"predecessor-version":[{"id":1832,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1793\/revisions\/1832"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1793"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1793"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1793"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}