Replies to post #437131 on Amarin Corp Plc (AMRN)

[Number sleven]

RMB, This article isn't about what the Supreme Court might do. It's more about how the issue of induced infringement should be framed. The author is telling us that the label on its own is not inducing infringement however; it is setting the stage for it. He outlined the fact that regulatory speech should not be ignored. Because of the label, it wouldn't take a significant active step to encourage infringement. His conclusion is summarized in the last paragraph.
Sleven,

[JRoon71]

RMB, in reading it, I took his comments to mean that he generally sides with Amarin. Yes, his argument was not overwhelming. But it seemed pretty clear to me that he believed that there was more than enough to at least allow the case to proceed, as the Federal Circuit decided in their reversal.

Here:

This scenario exemplifies the “label-plus” theory of inducement, wherein a generic drug’s label alone, even if it suggests infringing use, cannot constitute infringement because it falls within a congressionally authorized regulatory scheme. However, when a generic label closely aligns with an infringing use and is combined with additional active steps, inducement liability may arise. In my view, the label itself is not part of the active step, but instead creates the underlying fragile conditions that make it easy to induce infringement. In Hikma’s case, Federal Circuit concluded these active steps involved explicitly highlighting parallels to the branded drug Vascepa—such as marketing it as a “generic version” and emphasizing sales data strongly associated with the patented cardiovascular use—while omitting any explicit mention of the label’s carve-out. Note here that this was all at the motion-to-dismiss stage of the case; Amarin has not yet proven infringement but has alleged enough to allow the case to proceed into discovery.

And here:

In a typical patent inducement situation, minor promotional statements or commercial equivalence claims would ordinarily not be enough to constitute active inducement. Here though, we have a quite different setup given the major economic incentives and prescription patterns inherent in our pharmaceutical markets. For me, the issues fall back on the traditional elements of inducement:

Knowledge of the patent and awareness that the encouraged acts infringe;
Affirmative steps—beyond mere passive knowledge—that actively encourage, promote, or instruct infringement; and
Actual direct infringement resulting from those affirmative actions.
In the present scenario, Hikma clearly had knowledge of Amarin’s patents covering the CV indication. Its statements and marketing strategy involved active steps that arguably encouraged the infringement; and we have actual underlying infringement. I think the weakest evidence from the complaint is that that the infringement was a direct result of the Hikma’s actions beyond just selling the product with the label, but that is not the issue before the Supreme Court.