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13 January 20224 minute read

Skinny enough? Amarin v. Hikma reexamines induced infringment with carveout labels

On January 4, 2022, the District of Delaware issued an opinion granting a generic manufacturer’s motion to dismiss in Amarin Pharma, Inc. et. al. v. Hikma Pharms. USA Inc. et al., No. 20-C-01630-RGA-JLH D.I. 97 (D. Del., Jan. 4, 2021) (Amarin II). Just months after the Federal Circuit reaffirmed its prior decision that a generic drug manufacturer can be held liable for inducing infringement post-launch with a “skinny label,” the District of Delaware’s opinion in Amarin II appears to reach the opposite conclusion.  See, GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) (panel rehearing affirmed, 7 F.4th 1320 (Fed. Cir. 2021) (GSK).

Hikma’s skinny label

In Amarin II, the plaintiff, the branded manufacturer of icosapent ethyl (Vascepa®), sued the generic manufacturer Hikma, which had launched a generic version of icosapent ethyl with a skinny label that carved out the cardiovascular indication (the “CV Indication”).  Hikma’s skinny label included only the indication for the treatment of severe hypertriglyceridemia (the SH indication), which was the sole indication at issue in the pre-launch Hatch-Waxman litigation between the parties and in which Hikma prevailed.  See, Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 819 F. App'x 932 (Fed. Cir. 2020) (Amarin I).

In its second bite at the apple, the plaintiff alleged in Amarin II that its patents covering the CV Indication were infringed, notwithstanding the carveout, based on what remained in the label and Hikma’s public statements.

A narrow interpretation

Recognizing the importance of the GSK decision and the similarity of the fact-pattern presented, the Amarin II court acknowledged that generic manufacturers can be liable for inducing infringement of a patented method, even when the generic attempted to carve out the patented indications. But the Amarin II court interpreted GSK very narrowly and embraced the Federal Circuit’s admonition that GSK was “a case-specific review.”

Looking first at the skinny label, the Amarin II court found that a listing of side effects for the patented use was neither “instruction” nor “encouragement” for purposes of inducement.  Further, the court concluded that the removal of the patented use limitation from the label was not an affirmative statement that could be relied upon as evidence that the drug would be used for the patented indication.

Hikma’s press releases stated that its generic drug, like the generic in GSK, was equivalent to Vascepa® and was indicated, in part, for the patented indication.  In terms of anticipated sales, Hikma cited and relied on sales figures of Vascepa® that included sales for the patented indication. 

The generic manufacturer’s website also stated that the generic was AB rated in the therapeutic category for the patented indication.

Court relies on Grünenthal, not GSK

The Amarin II court found that while all of these statements were relevant to the issue of intent, they fell short of pleading an inducing act because they did not rise to the level of encouraging, recommending, or promoting the generic for the patented indication.

In the end, Judge Richard G. Andrews did not believe that the facts (as pled) were analogous to those of GSK.  Instead, he reached back to a pre-launch Hatch-Waxman case entitled Grünenthal GMBH v. Alkem Labs Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) for the proposition that a label with an indication that includes both infringing and non-infringing uses does not specifically encourage use of the generic for the patented treatment.  Although Grünenthal involved a skinny label, it was not a post-launch case like GSK and Amarin II, in which there was evidence of statements by the generic regarding equivalency to the branded drug and adoption of sales information that included the patented use.  Nevertheless, Judge Andrews relied on Grünenthal to avoid the result presented in GSK.

Moving forward: a more complicated roadmap

This result in Amarin II highlights what may be an irreconcilable split in the Federal Circuit case law on inducement that is ripe for Supreme Court review.

Finding inducement liability in pre- and post-launch skinny label cases may not necessarily turn on facts or evidence.  Instead, the crucial factor may be which Federal Circuit case the district court judge chooses to rely on.

Until such time as the split of authority is resolved, generic manufacturers must be careful in drafting not just their skinny labels but their press releases and the content on their websites. For brand manufacturers, the potential roadmap provided by GSK for asserting induced infringement, even when the generic manufacturer has limited its drug to a skinny label, just got more complicated.