HR 6485

The Skinny Labels, Big Savings Act aims to protect generic and biosimilar drug manufacturers from patent infringement lawsuits. Specifically, it establishes a ‘safe harbor’ that shields manufacturers from liability when they seek FDA approval for drugs labeled with only the approved uses of a drug, as opposed to all uses covered by a patent. This legislation clarifies that certain actions, such as submitting an approval application, promoting a drug with skinny labeling, or describing a generic drug as equivalent to the brand-name drug, do not constitute infringement, provided specific conditions are met regarding patent references.