{"id":3855,"date":"2024-06-25T21:57:02","date_gmt":"2024-06-26T02:57:02","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=3855"},"modified":"2024-07-07T10:05:31","modified_gmt":"2024-07-07T15:05:31","slug":"website-and-press-releases-created-plausible-claim-of-inducement-of-infringement-by-a-skinny-labelled-generic-product","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=3855","title":{"rendered":"Website and Press Releases Created Plausible Claim of Inducement of Infringement by a Skinny Labelled Generic Product"},"content":{"rendered":"\n

In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc.<\/a>, [2023-1169] (June 25, 2024), the Federal Circuit reversed the dismissal of Amarin\u2019s complaint for failure to state a claim for induced infringement. <\/p>\n\n\n\n

Less than a month after Hikma launched its generic icosapent ethyl product, Amarin sued
under 35 U.S.C. \u00a7 271(b), alleging that Hikma had induced infringement of U.S. Patent Nos. 9,700,537 and 10,568,861. through the content of Hikma\u2019s press releases, website, and product label evidence Hikma\u2019s specific intent to actively encourage physicians to directly
infringe the asserted patents by prescribing its generic icosapent ethyl product for the off-label CV indication, an indication for which Hikma did not get FDA approval. Hikma moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), arguing that Amarin had failed, as a matter of law, to allege facts that Hikma had taken active steps to specifically encourage infringement.<\/p>\n\n\n\n

The district court referred the case to a magistrate judge, who recommended denying the motion. The magistrate judge concluded that, based on the totality of the allegations, which relied not only on the content of the skinny label but also Hikma\u2019s press releases and website, Amarin had \u201cpleaded an inducement claim . . . that is at least plausible.\u201d Specifically, she noted that, \u201cnotwithstanding the lack of an express instruction regarding the CV indication in the \u2018Indications and Usage\u2019 section of Hikma\u2019s label, several other portions
of Hikma\u2019s label, taken together with Hikma\u2019s public statements, instruct physicians to use Hikma\u2019s product in a way that infringes the asserted patents.\u201d On de novo review, the district court declined to adopt the magistrate judge\u2019s recommendation and granted
Hikma\u2019s motion to dismiss.<\/p>\n\n\n\n

The Federal Circuit said that although this case has underlying features of a traditional Hatch-Waxman case, at bottom, it is nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. \u00a7 271(b). <\/p>\n\n\n\n

The Federal Circuit said that although this case has underlying features of a traditional Hatch-Waxman case, at bottom, it is nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. \u00a7 271(b). Accepting all well-pleaded facts as true and drawing all reasonable inferences in Amarin\u2019s favor, the Federal Circuit concluded that Amarin\u2019s complaint plausibly plead that Hikma actively induced healthcare providers\u2019 direct infringement, i.e., that Hikma encouraged, recommended, or promoted infringement.<\/p>\n\n\n\n

Amarin alleged that the clinical studies section, which describes statin-treated patients
with the same cardiovascular event history and lipid levels covered by the asserted patents, would be understood by physicians as a teaching that the product could be prescribed to treat cardiovascular risk. Amarin further alleged that Hikma\u2019s removal of the CV Limitation of Use language and the warning of potential side effects for patients with cardiovascular disease, communicate to physicians that Hikma\u2019s generic product could be used for the off-label CV indication — particularly since other drugs contain the CV Limitation.<\/p>\n\n\n\n

The Federal Circuit said that taken on its own, it might have agreed with the district court
(and Hikma) that the label does not, as a matter of law, recommend, encourage, or promote an infringing use. But, as the magistrate judge correctly observed, Amarin\u2019s theory of induced infringement is not based solely on the label. Counsel for Amarin explained that \u201cour case is not about the label standing alone, but to be clear, we do rely on portions of the
label\u201d). Rather, it is based on the label in combination with Hikma\u2019s public statements and marketing materials.<\/p>\n\n\n\n

The Federal Circuit noted that Hikima’s website promoted its product as broad enough to encompass both infringing and non-infringing uses, and its press releases, consistently referred to Hikma\u2019s product as a \u201cgeneric equivalent to Vascepa\u00ae\u201d or \u201cgeneric Vascepa\u00ae.\u201d <\/p>\n\n\n\n

Hikma\u2019s press releases broadly refer to the product as a \u201cgeneric version\u201d of Vascepa and provide usage information and sales data for the brand-name drug from which it is plausible
that a physician could discern an encouragement to use the generic for purposes beyond the approved indication. The Federal Circuit found that the allegations in the Complaint plausibly state a claim for induced infringement.<\/p>\n\n\n\n

.<\/p>\n","protected":false},"excerpt":{"rendered":"

In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., [2023-1169] (June 25, 2024), the Federal Circuit reversed the dismissal of Amarin\u2019s complaint for failure to state a claim for induced infringement. Less than a month after Hikma launched its generic … 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":[1],"tags":[],"class_list":["post-3855","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3855","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=3855"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3855\/revisions"}],"predecessor-version":[{"id":3856,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3855\/revisions\/3856"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3855"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3855"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3855"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}