[24-889] Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

Under Section 271b of the Patent Act, selling a product suited for both infringing and substantial non-infringing uses is lawful unless the seller actively induces the infringing use.

Congress later passed Se- Hatch-Waxman Section 8 to ensure that one infringing use will not foreclose selling a generic drug for a second non-infringing use.

So public statements entirely consistent with selling skinny label generic drug products under Section 8 cannot actively induce infringement.

Under our approach, and the one advanced by the United States, actively induced infringement when dealing with statements requires a clear message that necessarily promotes infringement.

The Court applied this standard in Grokster and more recently in Cox.

Active inducement cannot depend on whether doctors might read infringing instructions into product descriptions that on their face are entirely consistent with non-infringing use.

Amarin argues that generic drug companies must constantly discourage infringement with disclaimers that are explicit, but that turns the statute on its head.

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

And under the decision below, patent lawsuits filed after skinny labeled product launches will routinely survive a pleading challenge.

This shuts the Section 8 pathway down.

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

Reversal is needed to harmonize Section 8 with Section 271b and to encourage legitimate competition that reduces drug prices.

I welcome the Court's questions.

Wouldn't it have been safe to just simply say that, uh, that the generic drug was, um, uh, was only, uh, approved for the SH, uh, indication and nothing more?

Your Honor, Hikma did say that when it launched its product in the November press release, and it did say that on the accused website, but the law does not require that.

In Grokster and Cox, um, the Court made clear that failure to take affirmative steps to prevent infringement is, is not what the standard-

But what if you, what if, uh, respondent had engaged in a certain degree of self-adulation and said that, uh, "This is a great product for this, that, or the other," and you merely quoted it? Wouldn't that almost be baiting people into inducement or inducing people into, uh, um, using the product more broadly than, uh, the unpatented use?

I, uh, um...

The hypothetical is, is a little vague, but if, if Hikma or a generic were to send a clear message that-

Well, not using your language, but using their language.

They have patented uses that they think are great, but you could...

Why didn't you, you simply quote them.

Wouldn't that be a way to induce?

If, if Hikma quoted Amarin-

Yeah