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 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.
The case involves the well-known drug Vascepa, a medication to reduce heart disease for which Hikma’s product is a substitute. The drug has uses that are patented (known as the “CV indication” – referring to cardiovascular risk) and not patented (the “SH indication,” referring to severe 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 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.
The case involves the well-known drug Vascepa, a medication to reduce heart disease for which Hikma’s product is a substitute. The drug has uses that are patented (known as the “CV indication” – referring to cardiovascular risk) and not patented (the “SH indication,” 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’s patented uses.
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 “actively induce[d] infringement.” 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’s website about uses of the generic. Jackson’s opinion sternly rejected that view. Basically, the problem from the justices’ perspective was that the lower court focused on “whether doctors could plausibly read [a variety of statements by the generics manufacturer] as instructions to infringe,” as opposed to whether it “actively encouraged infringing uses.”
For Jackson, all of the challenged statements had an “obvious alternative explanation” other than encouraging infringement: Hikma “was just complying with the law or with standard industry practice.” Jackson started with the label, rejecting Amarin’s complaints about the details of the label “because, by statute, Hikma’s label must be identical to Amarin’s except for the carved-out [patented] use.”
Jackson turned next to statements in Hikma’s press releases describing its product as “generic Vascepa.” For Jackson, conformance to “‘normal industry practice’ to truthfully describe a generic drug as ‘equivalent’ to the brand-name competitor” should not be a basis for liability: “We 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.”
Having rejected Amarin’s reliance on the label and press releases, Jackson finished by explaining that “Amarin is wrong to [criticize] the statements on Hikma’s website for the same reason.” Amarin’s complaint was that the website described the therapeutic category for the drug too broadly – which could be taken implicitly to suggest that Amarin’s generic could be used for both the (on-patent) CV indication and the (off-patent) SH indication. Jackson found it “not plausible that Hikma ‘designed’ these statements ‘to stimulate others to commit’ infringement,” quoting the standard the justices applied in an earlier infringement case, MGM Studios, Inc. v. Grokster. Here, according to Jackson, “describing the therapeutic category [too broadly] is generally akin to describing a drug of leukemia as a ‘cancer drug’ (as opposed to a ‘leukemia drug’).” That is not, in her view, enough to suggest active inducement of infringement.
I would put this case together with the decision earlier this year in Cox v Sony, 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, in this case there is a statute to which the justices could point that directly calls for proof of “actively induc[ing] infringement,” which explains why this case was so easy for the justices to decide unanimously.
