Pharma “skinny label” case highlights shift in patent legal thinking

A newly published article by Spencer West US Intellectual Property Partner Jonas McDavit offers a compelling case study of the ongoing legal battle between Amarin Pharmaceuticals and Hikma Pharmaceuticals USA. 

With oral arguments imminent at the U.S. Supreme Court, Jonas highlights the competing narratives that underpin not only this dispute, but the future direction of intellectual property. 

About the case

The case concerns Hikma’s use of a “skinny label” to bring a generic version of Amarin’s drug to market, omitting a patented indication in line with the framework established under the Hatch-Waxman Act. But as Jonas’s analysis makes clear, the legal technicalities tell only part of the story, exposing two distinct strands of thinking within patent law – what Jonas describes as the “property” versus “home” approaches. 

The “property” strand is the traditional legal lens: patents as defined boundaries, akin to deeds, governed by claims and statutory interpretation, the framework most familiar to courts and practitioners. 

Arguing that this approach, while necessary, is often insufficient, through the lens of this case, and the reasoning seen in the U.S. Court of Appeals for the Federal Circuit, he highlights the growing influence of the “home” strand. This perspective moves beyond rigid boundaries to consider what a patent is ultimately protecting: the investment, effort, and real-world impact behind an innovation. 

The implications

It is this shift, Jonas suggests, that has significant implications. 

Hikma’s position reflects a policy-driven interpretation of the pharmaceutical landscape—one that prioritises access, competition, and the balance struck by Congress. In contrast, Amarin’s argument speaks to the protection of innovation itself, emphasising the risk that generics may erode the value of patented developments through indirect means, regardless of formal compliance. 

Jonas’s article reveals a broader tension at play: not just between two companies, but between two philosophies of law. 

The implications extend far beyond this single dispute. As courts increasingly grapple with complex, high-stakes innovation cases, the balance between “property” and “home” could shape how patents are argued, interpreted, and enforced in the years ahead. 

Published by Law 360, the article invites closer attention not just to what the courts decide, but how and why they decide it. 

Read the article here (paywall): 2 Strands Of Patent Law In High Court’s ‘Skinny Label’ Case