{"id":151,"date":"2026-06-05T20:10:43","date_gmt":"2026-06-05T20:10:43","guid":{"rendered":"https:\/\/americanservicereview.com\/?p=151"},"modified":"2026-06-05T20:10:43","modified_gmt":"2026-06-05T20:10:43","slug":"justices-reject-holding-generic-pharmaceutical-manufacturers-liable-for-decisions-of-pharmacists-about-prescribing-their-products","status":"publish","type":"post","link":"https:\/\/americanservicereview.com\/?p=151","title":{"rendered":"Justices reject holding generic pharmaceutical manufacturers liable for decisions of pharmacists about prescribing their products"},"content":{"rendered":"
\n

Among the three opinions arriving on Thursday from the April argument session was Hikma Pharmaceuticals USA v. Amarin Pharma<\/em>. As the quick turnaround would suggest, Hikma<\/em> is not a case that produced a lot of discord among the justices. The opinion of Justice Ketanji Brown Jackson for a unanimous court rejected the idea that a generics pharmaceutical manufacturer (Hikma) can be held responsible for infringements of patents held by the branded manufacturer (Amarin) based on the decisions of doctors and pharmacies to use the generic compound for patented uses of the drug.<\/p>\n

Read more Justices validate SEC\u2019s use of disgorgement in securities enforcement<\/a><\/p>\n

The case involves the well-known drug Vascepa,\u00a0a medication to reduce heart disease for which Hikma\u2019s product is a substitute. The drug has uses that are patented (known as the \u201cCV indication\u201d \u2013 referring to cardiovascular risk) and not patented (the \u201cSH indication,\u201d referring to severe hypertriglyceridemia). As it happens, when a generic drug is released for a branded drug that has both patented and non-patented uses, doctors and pharmacists routinely and indiscriminately use the generic for both uses, largely because state law often compels them to do so. The question here is whether Amarin can blame Hikma for such conduct involving the drug\u2019s patented uses.<\/p>\n

As the case comes to the justices, the U.S. Court of Appeals for the Federal Circuit held that Amarin had alleged enough to hold Hikma responsible under a statute requiring proof that Hikma \u201cactively induce[d] infringement.\u201d The lower court relied on a combination of three statements: the label used by Hikma; press releases from Hikma mentioning Vascepa; and statements on Hikma\u2019s website about uses of the generic. Jackson\u2019s sternly rejected that view. Basically, the problem from the justices\u2019 perspective was that the lower court focused on \u201cwhether doctors could plausibly read [a variety of statements by the generics manufacturer] as instructions to infringe,\u201d as opposed to whether it \u201cactively encouraged infringing uses.\u201d<\/p>\n

For Jackson, all of the challenged statements had an \u201cobvious alternative explanation\u201d other than encouraging infringement: Hikma \u201cwas just complying with the law or with standard industry practice.\u201d Jackson started with the label, rejecting Amarin\u2019s complaints about the details of the label \u201cbecause, by statute, Hikma\u2019s label must be identical to Amarin\u2019s except for the carved-out [patented] use.\u201d<\/p>\n

Read more On D-Day, did FDR violate the establishment clause?<\/a><\/p>\n

Jackson turned next to statements in Hikma\u2019s press releases describing its product as \u201cgeneric Vascepa.\u201d For Jackson, conformance to \u201c\u2018normal industry practice\u2019 to truthfully describe a generic drug as \u2018equivalent\u2019 to the brand-name competitor\u201d should not be a basis for liability: \u201cWe decline to put generics manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.\u201d<\/p>\n

Having rejected Amarin\u2019s reliance on the label and press releases, Jackson finished by explaining that \u201cAmarin is wrong to [criticize] the statements on Hikma\u2019s website for the same reason.\u201d Amarin\u2019s complaint was that the website described the therapeutic category for the drug too broadly \u2013 which could be taken implicitly to suggest that Amarin\u2019s generic could be used for both the (on-patent) CV indication and the (off-patent) SH indication. Jackson found it \u201cnot plausible that Hikma \u2018designed\u2019 these statements \u2018to stimulate others to commit\u2019 infringement,\u201d quoting the standard the justices applied in an earlier infringement case, MGM Studios, Inc. v. Grokster<\/em>. Here, according to Jackson, \u201cdescribing the therapeutic category [too broadly] is generally akin to describing a drug of leukemia as a \u2018cancer drug\u2019 (as opposed to a \u2018leukemia drug\u2019).\u201d That is not, in her view, enough to suggest active inducement of infringement.<\/p>\n

I would put this case together with the decision earlier this year in Cox v. Sony<\/em>, in which the court held that an internet service provider had not engaged in copyright infringement based on the activities of its subscribers. Here, as there, the justices started out skeptical about holding one large company responsible to another for the misconduct of a large group of third parties not before the court. And, unlike in Cox<\/em>, in this case there is a statute to which the justices could point that directly calls for proof of \u201cactively induc[ing] infringement,\u201d which explains why this case was so easy for the justices to decide unanimously.<\/p>\n

Read more Do Americans Support Expanding the Court?<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Among the three opinions arriving on Thursday from the April argument session was Hikma Pharmaceuticals USA v. Amarin Pharma. As the quick turnaround would suggest, Hikma is not a case that produced a lot of discord among the justices. The opinion of Justice Ketanji Brown Jackson for a unanimous court rejected the idea that a […]<\/p>\n","protected":false},"author":1,"featured_media":150,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-151","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-interesting"],"yoast_head":"\nJustices reject holding generic pharmaceutical manufacturers liable for decisions of pharmacists about prescribing their products - American Service Review<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/americanservicereview.com\/?p=151\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Justices reject holding generic pharmaceutical manufacturers liable for decisions of pharmacists about prescribing their products - American Service Review\" \/>\n<meta property=\"og:description\" content=\"Among the three opinions arriving on Thursday from the April argument session was Hikma Pharmaceuticals USA v. 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