Argument Recap

This month, the Federal Circuit heard oral argument in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., a case that attracted an amicus brief. In this case, the Federal Circuit is reviewing a district court’s grant of a motion to dismiss inducement claims under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. This is our argument recap.

Nathan K. Kelley argued for Amarin. He began by arguing that for induced infringement Amarin just has to “lay out a plausible theory of induced infringement which requires actual infringement.” Furthermore, he argued, Amarin has evidence showing intent to induce infringement with “press releases” and a “website.” He argued, in particular, that Hikma’s website displays a “therapeutic category” and that it does “not have approval to market throughout that entire category.” He emphasized that Hikma put out press releases that included representations its generic drug was the equivalent of Amarin’s drug Vascepa that is used to reduce heart attack and stroke, which is covered by the patents-in-suit.

A judge asked if there is an “obligation on a generic manufacturer”–like a duty of clarity–to make clear in advertising and press releases the uses of the generic drug. Kelley argued Hikma should consider the effect of the press releases “on the listener.” Kelley emphasized that the factual question in the case is “what a reasonable physician would understand the product would be marketed for.” As for how the question would be answered by the jury, Kelley suggested evidence would come in through testimony of people in the “health care industry.”

In his conclusion, Kelley emphasized the district court acknowledged evidence related to Hikma’s intent to market the generic in a similar way to Amarin’s drug Vascepa, and he argued that type of evidence should be considered by the jury.

Charles V. Klein argued for Hikma. Klein emphasized his view that Amarin’s argument is incorrect, because physicians may not “infer inducing conduct from vague statements.” Klein emphasized that inducement requires a showing of “affirmative steps in this context to tell health care providers they should perform . . . every element of an asserted patent claim.”

A judge asked whether there is any difference in the press release by Hikma here and a press release in a past case where the court found there was inducement of infringement. In Hikma’s press release, he argued, Hikma did not refer to a cardiovascular use of the drug and merely stated that it is a generic version of another judge. Klein argued the court in the previous case said this was not enough to induce infringement. He also emphasized that a defendant has no “obligation to disclaim infringement” and that Amarin, by contrast, has to show that “Hikma took affirmative steps to induce” infringement.

Klein argued the court should affirm that “there’s no plausible allegation” that Hikma is “actively encouraging a health care provider to actually perform every step of the patented method.” He pointed out, in this regard, that the district court found expert testimony “irrelevant because the label itself doesn’t instruct health care providers to actually perform each and every step” of the patented method.

Klein concluded by arguing that what matters in the case is whether the alleged statements in the Hikma press release or website “plausibly and actively encourage each and every step of the patented method.” Klein emphasized that they do not, and this is why summary judgement was granted.

In rebuttal, Kelley argued that in the previous case a jury was able to find inducement based on an advertisement that said the drug was generic and referred broadly to multiple uses. He argued in this case Hikma is trying to say that a jury could not plausibly find inducement because of a “little tweak” in the facts–that in Hikma’s press release Hikma refers to multiple uses. He emphasized that physicians observed Hikma’s press release and saw that its drug was the generic equivalent of Amarin’s drug. This, he argued, creates a question for the jury of inducement of infringement.

We will continue monitoring this case and report on developments.