Jeffrey E. Depp

The Supreme Court’s decision to hear Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. is puzzling—and revealing. On its face, the case presents a narrow question: whether a generic drug manufacturer can be held liable for inducing patent infringement based on how it markets a product approved under a so-called “skinny label.” The dispute turns on whether Hikma’s conduct plausibly encouraged physicians to prescribe its generic drug for a patented use. But the Court’s decision to grant certiorari reflects something broader: a continued focus on lowering drug prices through faster generic entry, even at the risk of undermining the patent incentives that make pharmaceutical innovation possible.

The ongoing debate over the nearly two-decades long battle to restore injunctive relief to prevailing patent owners is no doubt a vigorous one. Two different camps within the pro-strong-patent rights community have emerged. One camp consists of those backed by and/or supporting corporate innovators. The other camp consists of those supporting small, independent innovators.

Last week, the White House announced that the manufacturers of all ten of the drugs singled out by the Centers for Medicare and Medicaid Services (CMS) and its drug price negotiation program (DPNP) have “agreed” to participate therein. The announcement concerns the manufacturers reluctantly agreeing to subject themselves to the sweeping drug price “negotiation” provisions of the Inflation Reduction Act (IRA), which was passed last year. Those provisions empower CMS to essentially dictate whatever price it pleases for a set of prescription drugs, the first ten of which were announced at the end of August.