Yesterday’s argument in Hikma Pharmaceuticals USA v Amarin Pharma showed a bench once again dubious about litigation trying to hold a large company responsible for the actions of others that it does not control.
The specific dispute here involves a generic pharmaceutical manufacturer, Hikma, whose product can be dispensed for uses that both do and do not infringe on patents. The suit is brought by Amarin, which holds patents on uses of the branded pharmaceutical Vascepa, a medication to reduce heart disease for which Hikma’s product is a substitute. Specifically, Amarin seeks to hold Hikma responsible when pharmacists dispense Hikma’s generic product for uses that infringe on its patents. As in the Cox Communications case decided a few weeks ago, the justices seemed to doubt the propriety of imposing liability for the conduct of other parties.
The basic situation here is that the lower court (the U.S. Court of Appeals for the Federal Circuit, which is a specialized court that hears patent cases) upheld the validity of a complaint against Amarin that rests on three statements by it: the label on the product, press releases to potential investors, and statements on its web site. According to Hikma, these statements have actively encouraged its use for patented purposes.
The problem the manufacturer faced in defending the judgment before the court is that the relevant statute, the Patent Act, requires “active[] induce[ment]” of infringement and none of those three pieces of evidence had much persuasive force with the justices.
As for the label, because the text on the label is almost entirely compelled by the FDA, the justices found it difficult to blame the generics manufacturer for that; Justices Ketanji Brown Jackson and Elena Kagan seemed particularly dubious about that as a relevant piece of evidence. As for the press releases, they were directed to investors rather than doctors, which made some of the justices skeptical that they show anything about active intent to induce infringement by pharmacists (Jackson seemed the most outspoken here). As for the web site, the justices pointed out that it seemed to do little more than mention the drug as a generic for Vascepa and, in any event, had a disclaimer that at least some of the justices (Justice Neil Gorsuch taking the lead on this topic) seemed to find important.
The most interesting facet of the argument to me was that the justices seemed much less interested in sorting out how they would rule – which seemed to be a foregone conclusion – and much more interested in continuing a debate about why they agreed to hear the case in the first place. Early in the argument, for example, Justice Sonia Sotomayor suggested that the justices “say we’re not going to take [cases just for] error correction,” implying that the case was so fact-specific that there was no other reason to hear it. In the same vein, Justice Amy Coney Barrett commented that because the “key question” in the case “is a fact question, … I’m not sure why this is here except four of my colleagues wanted it to be.” Conversely, Justice Brett Kavanaugh – apparently one of those four – explained that as “to why this case is here, … I’m glad it’s here.” He then went on at some length to discuss filings that had persuaded him that the decision below would “have some serious implications market-wide.”
I would predict a succinct and prompt unanimous opinion saying as little as necessary about patent law and simply stating that none of the evidence is sufficiently probative of “active” inducement of infringement, as opposed to passive tolerance of it.