Bill > S1041

This bill modifies patent infringement rules for biological products, which are complex medical treatments like certain medications or therapies. Specifically, the bill limits the number of patents a reference product sponsor (the original drug manufacturer) can assert in an infringement lawsuit against a biosimilar applicant (a company seeking to create a generic version) to 20 total patents, with no more than 10 patents issued after a specific date. The bill allows courts to increase this patent limit under certain conditions, such as if the biosimilar applicant fails to provide necessary information or if there are material changes to the product. The patents must claim the biological product, its uses, or manufacturing methods, and must meet specific criteria like being filed more than 4 years after the original product's approval. The bill aims to balance innovation protection with creating opportunities for more affordable alternative biological products by providing clearer guidelines for patent challenges. These changes will apply to biosimilar applications submitted on or after the bill's enactment date, potentially making prescription biologics more accessible and competitively priced.

Justice

https://www.congress.gov/bill/119th-congress/senate-bill/1041/all-info