Limiting Patents in Drug and Biological Product Infringement Actions.
New rules limit the number of patents pharmaceutical companies can assert in lawsuits concerning generic drugs and biosimilar products. This aims to facilitate the market entry of cheaper alternatives, potentially lowering drug costs for citizens and increasing accessibility. The changes apply to applications submitted on or after the enactment date.
Key points
Companies suing for patent infringement on drugs or biological products can only assert one patent per patent group in a single action.
The limitation aims to reduce "patent thickets" that hinder the market entry of more affordable drug alternatives.
Potentially lower drug prices and greater accessibility for patients due to faster introduction of generics and biosimilars.
Status:
Expired
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