The “Skinny Labels, Big Savings Act” – What Are Its Implications?

Proposed legislation to change the process adjudicating patent infringement in cases involving “skinny labels” is a solution in search of a problem, as two Federal Circuit cases have recently shown the legal framework for assessing patent infringement remains stable and balanced.

Despite claims that the U.S. Court of Appeals for the Federal Circuit is undermining generics’ ability to rely on skinny labeling—which allows generic drug manufacturers to sell Food and Drug Administration-approved drugs that include only non-patented approved uses—judges have signaled they aren’t overhauling the current framework.

Calls for reform have persisted despite the law remaining unchanged, but it’s clear these demands are unfounded, and they propose the very disruption to the status quo they claim to address.

In this article for Bloomberg Law, Irena Royzman and Dana Sublett review the Federal Circuit’s relevant cases and analyze the contents of the “Skinny Labels, Big Savings Act,” discussing its potential implications for future “skinny label” patent infringement cases.