{"id":1956,"date":"2018-02-09T21:47:00","date_gmt":"2018-02-10T02:47:00","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=1956"},"modified":"2018-02-12T22:39:31","modified_gmt":"2018-02-13T03:39:31","slug":"anda-your-patent-is-not-infringed","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=1956","title":{"rendered":"Anda Your Patent is Not Infringed"},"content":{"rendered":"

In Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC<\/a>, [2017-1560] (February 9, 2018), the Federal Circuit affirmed the district court, finding that it\u00a0did not abuse its discretion in denying\u00a0Merck\u2019s request for additional samples and a new trial, that it did not err in\u00a0finding that Merck failed to demonstrate that Amneal\u2019s\u00a0ANDA product, which formed the basis for the district\u00a0court\u2019s noninfringement finding, was not representative of\u00a0Amneal\u2019s final commercial product, and that district court did not clearly err in finding that\u00a0three Raman peaks were required to prove infringement.<\/p>\n

On the denial of additional discovery issue, the Federal Circuit reviews a district court\u2019s denial of additional\u00a0discovery under regional circuit law, and the Third Circuit will not disturb a denial of additional discovery
\nabsent an abuse of discretion and \u201ca showing of\u00a0actual and substantial prejudice.\u00a0 The Federal Circuit found the question “a close one.” The Federal Circuit noted that Amneal\u2019s failure\u00a0to abide by the standing discovery order resulted in a trial\u00a0situation that was “less than ideal.\u201d\u00a0 However the Federal Circuit concluded that the district court did not abuse its discretion in denying the additional discovery, noting that the district court took adequate steps to ensure that\u00a0proceeding with trial would not prejudice Merck.<\/p>\n

The Federal Circuit said that the\u00a0ultimate determination of infringement is a question of\u00a0fact, which is reviewed for\u00a0 clear error. The Federal Circuit rejected Merck’s argument that the district court improperly determined infringement of an intermediate product, rather than the final product, as imposing a\u00a0heightened evidentiary standard in ANDA\u00a0cases not supported by case law.\u00a0 The Federal Circuit said that\u00a0regardless of the type of\u00a0sample (e.g., commercial or batch), the critical inquiry is
\nwhether it is representative of what is likely to be approved\u00a0and marketed.<\/p>\n

Finally, the Federal Circuit\u00a0discerne no clear error in the district court\u2019s
\nfact-finding of noninfringement.\u00a0\u00a0The district court found Amneal\u2019s expert
\nevidence \u201cat least as consistent and credible\u201d as Merck\u2019s\u00a0expert and concluded that Merck failed to prove infringement\u00a0by preponderant evidence.\u00a0\u00a0Amneal\u2019s\u00a0expert testified that although a single\u00a0peak can be used at times, three Raman peaks are typically\u00a0used to absolutely confirm the presence of molecules\u00a0in complex mixtures like MFM. Because the noninfringement\u00a0finding was supported by this evidence in the record, the Federal Circuit concluded that the\u00a0district court did not clearly err in its noninfringement\u00a0finding.<\/p>\n","protected":false},"excerpt":{"rendered":"

In Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, [2017-1560] (February 9, 2018), the Federal Circuit affirmed the district court, finding that it\u00a0did not abuse its discretion in denying\u00a0Merck\u2019s request for additional samples and a new trial, that it … 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":[65,16,1],"tags":[],"class_list":["post-1956","post","type-post","status-publish","format-standard","hentry","category-discovery","category-infringement","category-uncategorized"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1956","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=1956"}],"version-history":[{"count":3,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1956\/revisions"}],"predecessor-version":[{"id":1967,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/1956\/revisions\/1967"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1956"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1956"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1956"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}