Generic Drug Access: Patent Shield for 'Skinny Labels' to Lower Costs.
This Act aims to accelerate the market entry of cheaper generic and biosimilar drugs. It creates a legal safe harbor for generic manufacturers who intentionally omit patented uses from their product labeling. This change means citizens could gain faster access to more affordable medication options, potentially reducing healthcare costs and increasing treatment availability.
Key points
Legal Protection for Generics: Companies can market cheaper drugs even if the original drug has a patent on a specific method of use, provided the generic does not promote that specific use.
Faster Access to Affordable Drugs: This change is designed to speed up the process of bringing generics and biosimilars to market, which should result in lower prescription drug prices for consumers.
The 'Skinny Labels' Rule: A generic manufacturer does not infringe a patent if their labeling, promotion, or marketing does not reference the patented condition or conditions of use.
Retroactive Application: The new rules apply to conduct occurring before, on, or after the enactment date, affecting all pending judicial proceedings.
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