This bill protects generic and biosimilar drug manufacturers from being sued for patent infringement when they use a process called "skinny labeling." Here's what that means: when a drug's patent expires for certain uses but not others, the FDA allows generic manufacturers to get approval and sell the drug only for the uses that are no longer patented. The problem is that a recent court case said manufacturers could still be sued for patent infringement even when doing this legally approved process. This bill fixes that by saying manufacturers cannot be held liable for patent infringement simply because they sought FDA approval for a skinny label, marketed a drug with FDA-approved skinny labeling, or described their product as a generic equivalent to the brand-name drug.

In practical terms, this helps make generic and biosimilar drugs more affordable and accessible to patients. Without this protection, drug manufacturers would be hesitant to use skinny labeling because of the legal risk, which would delay generic versions from reaching the market. The bill essentially says the FDA's approval process is the final word—if the FDA says it's okay to sell a drug with limited labeling, manufacturers shouldn't face patent lawsuits for doing exactly what the FDA approved. This encourages competition in the drug market and helps keep medication costs down for consumers.

Skinny Labels, Big Savings Act

Hickenlooper, John W.

Skinny Labels, Big Savings ActThis bill provides a statutory safe harbor from patent infringement claims for generic or&nbsp;biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.Under current law, the Food and Drug Administration (FDA) may approve generic and&nbsp;biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:<ul><li>submitting or seeking approval of a skinny label for a generic or biosimilar drug;</li><li>promoting or commercially marketing a drug with skinny labeling approved by the FDA; or</li><li>describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.</li></ul>The bill also applies the safe harbor to similar actions under the Public Health Service Act.