By Kevin E. Noonan –

In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not covered in their approved label (known as a “skinny label; see “GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)“).  In the latest instance (see “Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)“), the Solicitor General filed its amicus brief (at the Supreme Court’s behest) regarding the issue, once again (as has been done before; see “Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation“) arguing that the Court should grant certiorari.

Today, the Court granted Hikma’s certiorari petition, which recited the following Questions Presented:

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

2. Does a complaint state 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?

This case follows patterns found before in instances where the Court has granted cert: the Federal Circuit has rendered decisions with competing stances taken by members of the Court and the decision has “real world” implications on important societal matters (i.e., it isn’t just a patent dispute between the parties but will influence important policy outcomes; here, regarding the availability of generic drugs).

The Court’s Order does not specify which flavor of these Questions they have deigned to consider, and how Hikma crafts the questions it actually argues will be seen in coming months.  However, the universal sentiment on both sides of the aisle are that drugs cost too much, and to the extent this sentiment resonated with the Justices (and whether such resonance with common sentiment is, as in other instances, a factor in their decision to hear the case) will also become evident in time.  In this way, this certiorari decision is reminiscent of the Court’s grant in Association of Molecular Pathology v. Myriad without the predictably fraught outcomes arising therefrom.  After all, what could be bad about lower drug costs (other than reducing the availability of innovator drugs to be copied by generic drugmakers)?  We shall see.