Hikma v. Amarin: What the Supreme Court’s Decision Means for Skinny Labels and Induced Infringement

Introduction

The Supreme Court has issued a unanimous decision in Hikma v. Amarin, holding that Amarin did not meet its pleading burden of plausibly alleging that Hikma induced infringement of Amarin’s patents relating to reducing the occurrence of cardiovascular events. This decision provides a significant reset on the Federal Circuit’s assessing sufficiency of pleading induced infringement by specifically focusing the analysis on the affirmative actions taken by the alleged induced infringer, rather than on how a direct infringer might view and respond to such actions. This case is important for brand manufacturers pursuing follow-on indications for previously approved drugs, and for generic drug manufacturers seeking to obtain approval for unpatented indications via a section viii (skinny label) statement.

Background

Amarin markets Vascepa® (icosapent ethyl) for the treatment of severe hypertriglyceridemia (the “SH indication”) as well as for reducing cardiovascular events in hypertriglyceridemia patients who already take statins (the “CV indication”). Hikma filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to market generic icosapent ethyl solely for the SH indication. To address Amarin’s Orange Book-listed patents for the SH and the CV indications, Hikma successfully challenged the validity of the SH patents and submitted a section viii statement to carve out the CV indication from its proposed label. Shortly after the launch of Hikma’s generic icosapent ethyl product, Amarin sued Hikma for induced infringement based on the totality of Hikma’s activities, including its generic label, patient information leaflet, website, and press releases. Inducement of infringement requires the accused party to “actively” induce infringement of the asserted patent by a direct infringer. The District Court held that Amarin failed to meet the pleading standard required under Iqbal and Twombly and dismissed the case. Amarin appealed to the Federal Circuit Court of Appeals, which reversed, holding Amarin’s pleading to be sufficient to plausibly allege induced infringement. The Supreme Court has now reversed the Federal Circuit, holding that Amarin did not plausibly allege induced infringement and pointedly redirecting the Federal Circuit’s recent approach to analyzing plausibility of induced infringement claims.  

Supreme Court’s Reasoning

The Supreme Court emphasized that the issue “is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, [and] not merely whether doctors could plausibly read the alleged statements as instructions to infringe.” The Court further noted that the focus must be on the actions of the alleged induced infringer, rather than the possible actions of a downstream direct infringer to avoid, in the words of its 2005 Grokster decision, “trenching on regular commerce” based on such a contingent chain of events.

The Court concluded that there were “obvious alternative explanations” for some of the Hikma statements relied upon by Amarin to show inducement. For example, the content of Hikma’s label was dictated by statute, according to the sameness standard required for generics. Hikma’s use of the term “generic Vascepa” to refer to its own product was consistent with normal industry practice. Regarding the alleged Hikma omissions relied upon by Amarin, such as Hikma’s failure to warn doctors that its drug was not approved for the patented CV indication, the Court ruled that these were insufficient to support an allegation of active inducement, highlighting the need for affirmative actions by the accused inducer. The Court considered the remaining alleged statements in Hikma’s patient leaflet, website, and press releases vague and further noted that combining them with speculation about what a medical practitioner might do in response does not convert them into the requisite affirmative actions.

Conclusion and Takeaways

While this decision does not change the legal standard for plausibly pleading induced infringement, it provides insight into activities that could create liability for generic drug manufacturers seeking approval on only unpatented indications for drugs with remaining patented indications. In addition, although the Court made no pronouncement that a section viii label should be afforded a safe harbor, the Court’s holding shows that, without more, a skinny label like Hikma’s is an insufficient basis to plead induced infringement.

Brands would be well-advised to strategically re-evaluate pursuing a second indication approval for a previously approved drug with differential patent or regulatory exclusivity term. Doing so may invite loss of market share and potential inability to recoup development costs, due in part to generics with skinny label approvals and off-label uses.

We regularly counsel both generic and brand-name pharmaceutical companies on Hatch-Waxman strategy and patent disputes. Please contact us if you have any questions or would like to discuss how this decision may affect your IP strategy.