Orange Book Blog

By: Rocco Screnci

The Supreme Court heard oral argument yesterday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. This is a case and an issue that we (and many others) in the pharma-patent world have been watching for a while. But for those who haven’t followed this case, here is a recap of what led us to the Supreme Court:

• Amarin obtained a New Drug Application (NDA) for Vascepa, a drug that was originally indicated for lowering triglycerides in patients who have severe hypertriglyceridemia. (the “SH Indication”)
• Seven years later, Amarin obtained approval for a new indication: To reduce risk of certain cardiovascular issues when used as an adjunct to maximally tolerated statin therapy in patients with elevated triglycerides. (the “CV Indication”)
• In 2016, before Amarin received the CV Indication, Hikma filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification challenging Amarin’s patents that covered the SH Indication.
• Hikma prevailed on its Paragraph IV certification. But because Amarin obtained the CV Indication before Hikma prevailed on its Paragraph IV challenge, Hikma needed to address the CV Indication before the FDA could approve the ANDA.
• Hikma thus filed a section viii statement, seeking approval only for the uses not covered by Amarin’s patents covering the CV Indication. This led to a so-called “skinny label” for Hikma’s generic product, meaning that the label would omit the CV Indication, and Hikma could only market its generic for the SH-indicated use.
• Though the skinny label carved out the CV indication under the “Indications and Usage” section, the label still referenced potential side effects for people with cardiovascular disease. It also referenced the clinical trial that led to the CV Indication.
• Upon receiving FDA approval of the ANDA, Hikma began marketing its generic product as a “generic version” of Vascepa, Vascepa’s “generic equivalent,” or “generic Vascepa.” Hikma also described its product as being a generic for “hypertriglyceridemia” and referenced Vascepa’s total sales (i.e., sales for both SH-indicated and CV-indicated uses).
• Amarin filed suit, alleging that Hikma’s label and post-approval communications induced infringement of Amarin’s CV Indication patents for several reasons:
  • Press releases described the “generic version” of Vascepa; A press release in which Hikma referenced Vascepa’s total sales (i.e., sales for both SH-indicated and CV-indicated uses); Hikma’s removal of a statement from the label regarding the unknown effects of the active ingredient on cardiovascular mortality and morbidity; The label’s inclusion of potential side effects for people with cardiovascular disease and mention of the clinical trials related to the CV Indication; and
  • Website materials that described Hikma’s product as therapeutically equivalent to Vascepa for treatment of hypertriglyceridemia, which Amarin described as being broader than the permitted SH Indication.

The district court dismissed Amarin’s complaint under Federal Rule of Civil Procedure 12(b)(6), noting that the allegations in the complaint did not rise to the level required to allege induced infringement under 35 U.S.C. § 271(b). To that end, the district court ruled that Amarin’s allegations fell short of the necessary “encourage[ing], recommend[ing], or promot[ing]” of the patented use (”taking Hikma’s generic for the reduction of CV risk.”).

The Federal Circuit reversed on appeal. The focus of the analysis turned not on the allegations concerning the label, but on the allegations about the label plus the allegations of Hikma’s other actions. As the Federal Circuit noted, “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.” Indeed, the Federal Circuit expressed that it would very likely agreed with Hikma if Amarin’s inducement claims were based solely on the label. Even so, the Federal Circuit held that, at the pleading stage, the additional allegations about Hikma’s press releases and website were enough to plausibly allege that Hikma actively induced infringement of the CV Indication patents.

Hikma petitioned for certiorari, and the Supreme Court of the United States accepted to hear the case on two questions presented:

(1) Whether, when a generic drug label fully carves out a patented use, allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) are enough to plead induced infringement of the patented use; and

(2) whether a complaint states a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use

Argument this morning began, as it does in every Supreme Court case, with arguments from petitioner’s counsel. Hikma’s lawyer started his argument by framing the Federal Circuit’s decision as one that requires generic makers to monitor and actively discourage infringement, which is more than the law requires. Such a requirement, he urged, would disrupt the delicate balance struck by the Hatch-Waxman Act and effectively nullified the section viii pathway by subject generic makers to, at best, paying the hefty legal fees required to defend a lawsuit beyond the pleading stage.

The justices’ questioning of Hikma’s counsel was relatively brief. The most interesting questions were asked by Justice Sotomayor and Justice Jackson. Justice Sotomayor emphasized her concern with announcing bright-line rules in the case because, at bottom, the case was resolved on a motion to dismiss, which presents a case-specific and ultimately fact-specific inquiry. As she noted during her questioning, the Supreme Court usually does not engage in error correction. Justice Jackson, for her part, sought clarification about Hikma’s labeling, asking whether FDA would even permit Hikma to add a disclaimer. This questioning seemed mostly rhetorical, which is a tactic justices may use to signal their position and potentially persuade their colleagues to join them.

Following Hikma’s opening argument, an attorney from the Solicitor General’s office argued. The SG Office’s participation in oral argument is a somewhat common occurrence—albeit slightly rarer in IP cases—when the case involves important issues involving national policy. Deputy Solicitor General Malcolm Stewart, a career attorney in the SG’s office, argued on behalf of the United States in support of Hikma.

A slightly livelier bench asked Deputy SG Stewart questions on topics ranging from the broad policy concerns to purely legal questions. On the former issue, Justices Jackson and Kavanaugh chimed in, both inquiring about the economic consequences for generic manufacturers if the Court set too low a bar for induced infringement in skinny-label cases and how that may disrupt the balance struck by Hatch-Waxman. On the latter, Justice Sotomayor reiterated her concerns about setting bright-line rules. This is a concern the Chief Justice seemingly shared, as he expressed skepticism about the government’s position and the adoption of a bright-line rule that made it too easy for generic companies to avoid induced infringement. Deputy SG Stewart countered this point by noting that the high burden of pleading inducement was “by design” and consistent with the traditional standards for induced infringement. Finally, Justice Alito and Justice Kagan used their razor-sharp styles of questioning to home in on the contours of what legal ruling was at stake in this case. Justice Kagan questioned whether and how the FDA’s determinations about the generic’s label should factor into the analysis. And Justice Alito, in typical fashion, deployed hypotheticals to find the limits of the government’s proposed legal test: What if Hikma not only described its product as “generic Vascepa,” but also mentioned that Vascepa is approved for CV risk? What if Hikma said that ”studies show” that the active ingredient reduces CV risk? Both would, as the government conceded, likely qualify as induced infringement.

After Deputy SG Stewart finished his argument, Amarin’s counsel began to argue his case. He began by noting that the case was not a Hatch-Waxman or skinny-label case, but rather a run-of-the-mill induced infringement case. As he explained, the ultimate issue of inducement is fact intensive and thus not something a court should ordinarily resolve on a Rule 12(b)(6) motion to dismiss, where the Court must accept all well-pleaded allegations as true and draw all reasonable inferences in the non-moving party’s favor.

After counsel for Amarin’s opening remarks, the Justices began asking questions. The bench was notably more interested in asking questions, with each justice (except for the Chief Justice and Justice Sotomayor) interjecting at least once. During this round of argument, two interesting threads emerged.

First, an important legal issue raised in response to questions from Justices Kagan, Gorsuch, and Jackson involved the pleading standard. As Justice Kagan observed, press releases and promotional websites are typically done to influence investors, not prescribers. This creates a problem for Amarin because there would be a disconnect between Hikma’s intent and the unlawful activity. Put differently, Hikma’s intent in releasing the at-issue press releases was to influence investors to buy Hikma’s stock, not to persuade medical professions to prescribe Hikma’s product for off-label, patented uses. Or as Justice Jackson explained: Amarin’s framing of the case improperly focused on how prescribers interpreted the press releases rather than on what Hikma intended in making those press releases. Justice Gorsuch pointed out that this disconnect could pose problems because the pleading standard requires plausibility, not mere possibility. So Amarin would have needed to allege facts indicating that Hikma’s intent in those marketing materials was more likely unlawful (i.e., to promote infringement) than lawful (i.e., to influence investors). In response, Amarin’s counsel noted that Hikma did not challenge the adequacy of the allegations on the “intent” element, so it should not be a basis for reversing the Federal Circuit’s decision.

Second, counsel for Amarin repeatedly emphasized that Amarin had not sued other generic companies. Those companies, unlike Hikma, had not marketed their products in a way that Amarin construed as promoting the patented CV-indicated use. This emphasis seemed to quell some concerns about the impact of the case on generic pharmaceuticals and the viability of the section viii pathway.

So where does this leave things? For now, it is tough to say. My impression is that the Supreme Court is unlikely to write a sweeping opinion that drastically broadens or narrows what qualifies as induced infringement in cases involving skinny labels. I think Amarin can expect a narrow decision that states that, under the generous pleading standard, it has alleged enough facts to support a finding of induced infringement. That said, I would not be surprised if the Court issued a civil-procedure-heavy opinion that rules against Amarin and holds that Amarin’s allegations do not cross the line of plausibility, as Amarin’s allegations make it equally likely that Hikma’s intent was entirely lawful as it was unlawful.