{"id":5226,"date":"2026-06-04T19:00:00","date_gmt":"2026-06-05T00:00:00","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=5226"},"modified":"2026-06-07T20:18:01","modified_gmt":"2026-06-08T01:18:01","slug":"supreme-court-fat-chance-that-hikmas-skinny-label-and-statements-will-induce-infringement","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=5226","title":{"rendered":"Supreme Court: Fat Chance that Hikma’s Skinny Label and Statements Will Induce Infringement"},"content":{"rendered":"\n

In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma<\/em>, 608 U.S. ____ (2026), the Supreme Court reversed the Federal Circuit, holding that Amarin failed to state a claim for active inducement of its patents on Vascepa.<\/p>\n\n\n\n

The Court began by identifying the three requirements of an inducement claim: (1) direct infringement by a third party; (2) the inducer’s knowledge that the induced acts constitute infringement; and (3) the inducer must take active steps to encourage direct infringement.<\/p>\n\n\n\n

Hikma submitted an ANDA to market Vascepa for severe hypertriglyceridemia (the SH indication), and succeeded in invalidating Hikma’s patent on the treatment of severe hypertriglyceridemia. In the meantime, the FDA approved Vascepa for treating hypertriglyceridemia in patients already on statins (the CV indication) and Amarin obtained two new method of use patents for the CV indication. Hikma went forward preparing to mark Vascepa adopting a skinny label only referencing the now-unpatented SH indication, preparing a leaflet that its drug was for “people who have heart (cardiovascular) disease”; and describing its product as “therapeuticallly equivalent to Cascepa, and listing its therapeutic category broadly as “hyperglyceridemia”; and issuing a series of press releases describing its product as “generic Vascepa.”<\/p>\n\n\n\n

The Supreme Court said that inducement must involve the taking of affirmative, as opposed to passive, steps to bring about the desired result of patent infringement. To avoid interfering with “regular commerce” ordinary acts incident to product distribution are insufficient to support liability. The Supreme Court found that Hikma’s statements came up short.<\/p>\n\n\n\n

Of all of Hikma’s statements, the press releases calling their product generic Vascepa see the most culpable, since the product was not a replacement for all indications., However the Supreme Court dismissed this, explaining that it was to truthfully describe a generic drug as an “equivalent” to the brand-name comparator. The court declined to “put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.” <\/p>\n\n\n\n

The Supreme Court explained the law requires active not passive inducement, so the question is not merely whether the statement could be plausibly understood to induce infringement, but whether they plausibly understood to induce infringement. Viewed in that light, the Supreme Court found Hikma’s statements to be implausibly roundabout ways to induce medical providers to infringe.<\/p>\n\n\n\n

It would seem that if Amarin gave different names to the formulation for different indications — even something as simple as Vascepa-SH and Vascepa-CV would have prevented Hikma from referring to its product as generic Vascepa, instead having to use “generic Vascepa-SH” more clearly indicated that it is not approved for the Vascepa-CV indication.<\/p>\n","protected":false},"excerpt":{"rendered":"

In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, 608 U.S. ____ (2026), the Supreme Court reversed the Federal Circuit, holding that Amarin failed to state a claim for active inducement of its patents on Vascepa. The Court began by identifying … 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":[27],"tags":[],"class_list":["post-5226","post","type-post","status-publish","format-standard","hentry","category-inducement"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/5226","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=5226"}],"version-history":[{"count":1,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/5226\/revisions"}],"predecessor-version":[{"id":5227,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/5226\/revisions\/5227"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5226"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5226"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5226"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}