Hikma v. Amarin: Supreme Court Reins in Induced Infringement Claims Against Skinny Label Generic Drugs

Despite generating a lot of commentary, Hikma v. Amarin was in essence a case about pleading standards for induced infringement for a skinny label drug product. Specifically, it involved an Abbreviated New Drug Application (ANDA) filed by Hikma for a generic form of Amarin’s VASCEPA product with a section viii carve out. The FDA had approved VASCEPA in 2012 for the treatment of severe hypertriglyceridemia (“SH indication”) and in 2019 for reducing cardiovascular risk in hypertriglyceridemia patients already taking statins (“CV-indication”). 

After Amarin’s SH-indication patents were found invalid, Hikma supplemented its ANDA with a section viii statement seeking approval of a “skinny label” product for only the SH indication. The FDA approved Hikma’s ANDA with the skinny label and assigned an “AB” rating. Hikma launched its skinny label product and Amarin filed suit alleging that the totality of Hikma’s statements (e.g., skinny label, patient information leaflet, website, and press releases) actively induced others to infringe Amarin’s CV-indication method-of-use patents. The district court granted Hikma’s motion to dismiss for failure to state a claim, but the federal circuit reversed, holding that it was “at least plausible that a physician could read” the relevant statements “as an instruction or encouragement to infringe.”

The U.S. Supreme Court held that Amarin failed to state a claim for inducement and that its complaint could not survive Hikma’s motion to dismiss.  The court identified the central question as “whether Amarin plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe.”  Here, the court stated that the requisite “active steps” require affirmative action “to bring about the desired result” of infringement and that “ordinary acts incident to product distribution” are insufficient to support liability. The court rejected the federal circuit’s approach of asking whether statements could be read as instructions.

Regarding the information retained in Hikma’s label concerning a clinical study involving patients taking statins, the court found this was required by statute and thus not encouragement to infringe – in essence refusing “to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.”

The court also held that Amarin could not rely on “mere omissions, inactions, or nonfeasance” (e.g., the label’s omission of the CV Limitation of Use or the press releases’ failure to mention that Hikma's approved use was limited to the SH indication) to plausibly allege active inducement.

And the court found vague statements (e.g., the patient information leaflet’s warning about side effects and disclaimer that medicines are sometimes prescribed for other purposes) comprised “implausibly roundabout ways to induce medical providers to infringe” and, thus, insufficient to establish inducement. The court noted that the website’s description of the therapeutic category as “hypertriglyceridemia” and the product’s “AB” rating did not plausibly comprise statements designed “to stimulate others to commit” infringement, and the sales information in Hikma's press releases established at best “possible” but not “plausible” acts comprising inducement.

In a case several Justices clearly did not want to take (made clear during oral arguments), the court (i) found that “Amarin misse[d] the mark in argu­ing that it need not do more than ‘allege . . . a plausible chain of events through which statements made by [Hikma] could lead a healthcare provider . . . to prescribe or dispense Hikma’s drug to reduce a patient’s cardiovascular risk,” (ii) reversed, and (iii) sent the case back to the Federal Circuit with skinny labels alive and well.