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U.S. Supreme Court Oral Arguments

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

U.S. Supreme Court Oral Arguments

Oyez

Government & Organizations, National

4.7661 Ratings

🗓️ 29 April 2026

⏱️ 60 minutes

🧾️ Download transcript

Summary

A case in which the Court will decide (1) when a generic drug manufacturer excludes a patented use from its label, whether it still be liable for inducing infringement if it calls its product a “generic version” of the brand-name drug and cites publicly available information about the brand-name drug's sales; and (2) whether a patent infringement complaint can survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use.

Transcript

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0:00.0

We'll have argument next in case 24889, Hickma Pharmaceuticals versus Amerin Pharma.

0:06.6

Mr. Klein.

0:07.6

Thank you, Mr. Chief Justice, and may it please the Court.

0:10.7

Under Section 271B of the Patten Act, selling a product suited for both infringing

0:17.4

and substantial non-infringing uses is lawful unless the seller actively induces the infringing and substantial non-infringing uses is lawful, unless the seller actively induces

0:23.9

the infringing use. Congress later passed Hatchwaxman Section 8 to ensure that one infringing

0:31.2

use will not foreclose selling a generic drug for a second non-infringing use. So public statements entirely consistent with

0:40.4

selling skinny-labeled generic drug products under Section 8 cannot actively induce infringement.

0:47.5

Under our approach and the one advanced by the United States, actively induced infringement

0:53.9

when dealing with statements requires

0:56.7

a clear message that necessarily promotes infringement.

1:01.3

The Court applied this standard in Groxer and, more recently, in Cox.

1:06.3

Active inducement cannot depend on whether doctors might read infringing instructions into product

1:13.7

descriptions that on their face are entirely consistent with non-infringing use.

1:21.0

Amarin argues that generic drug companies must constantly discourage infringement with

1:27.1

disclaimers that are explicit, but that

1:30.3

turns the statute on its head.

1:33.3

Agreeing with Amarin, the Federal Circuit basically swapped the statutory term active for its

1:39.4

antonym, passive.

1:42.0

And under the decision below, Patt patent lawsuits filed after skinny labeled product launches

1:47.6

will routinely survive a pleading challenge. This shuts the Section 8 pathway down. Generic

1:54.9

companies won't choose that pathway if at best it means paying millions in legal fees and, at worst, a massive

...

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