The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an exercise of evaluating the sufficiency of a pleading in an ordinary induced infringement case. The court states multiple times that "this appeal is not a Hatch-Waxman case arising under 35 U.S.C. § 271(e)(2)(A), in which the alleged act of infringement was Hikma's submission of its ANDA." Instead, the panel makes it clear that the heart of the case involved allegations of induced infringement that focused on statements made by Hikma in press releases and on its website and that such statements were sufficient to survive a motion to dismiss, although the court is clear that it is not saying that the allegations are sufficient to establish inducement.
At the end of the day, the case can best be understood as a word of caution that any public statements and press releases about approvals or going to market with a skinny-labeled product should be clear that the product is only approved and will only be marketed for the limited indication that remains in the approved label.
The case specifically involved a situation where Hikma carved out a newly approved CV indication that Amarin had obtained, submitting a section viii statement to the corresponding patents. The CV indication is absent from Hikma's label, but the label does contain a warning about a side effect that might be experienced by people with CV disease or diabetes. The crux of the Federal Circuit's discussion, however, focuses on a series of press releases that Hikma issued when it was clearing the other patents and obtaining approval. Those releases include statements that Hikma's product was a "generic version" or "generic equivalent" of Vascepa and provided sales data for Vascepa that include all of its uses, including for the CV indication. Hikma also lists the product on its website as being "AB" rated to Vascepa. The court does note that "in small lettering" on its website, Hikma indicated that its "generic version is indicated for fewer than all approved indications of the Reference Listed Drug."
Amarin sued Hikma after it launched, and Hikma obtained a dismissal under Rule 12(b)(6) from Judge Andrews in the District of Delaware. The procedural posture of the case was a focus of the court's decision, and it repeatedly emphasizes that it has to take all allegations in the complaint as true and determine whether the allegations plausibly plead active inducement by Hikma. As noted above, the court spends a couple of pages and multiple paragraphs explaining that this is not a Hatch-Waxman case, noting that "this is not a section viii case in which the patent owner's claims rest solely on allegations that the generic manufacturer's proposed label is 'not skinny enough,' such that the label alone induces infringement." Instead, the court calls this "nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b)."
Interestingly, the Federal Circuit states that it "may agree with the district court (and Hikma) that the label does not, as a matter of law" induce infringement. But, focusing on the press statements and Hikma's website, the panel concludes that the allegations were sufficient to plausibly state a claim for induced infringement. The case will now go back to the district court for discovery to commence, although it's unclear whether Amarin will be able to establish inducement as the record develops.
This decision is certainly a warning to generic and biosimilar companies to be mindful of press releases and website statements when they launch skinny-labeled products. However, it does not appear to fundamentally change the law of induced infringement in the Hatch-Waxman context prior to a product being launched.
[T]his is not a section viii case in which the patent owner's claims rest solely on allegations that the generic manufacturer's proposed label is 'not skinny enough,' such that the label alone induces infringement.
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