US SB1041

Limits brand-name biologic drug manufacturers to asserting a maximum of 20 patents in infringement lawsuits against biosimilar applicants, with no more than 10 of those patents issued after a specified statutory date

Targets patents filed more than 4 years after the reference biologic product was approved, or patents claiming manufacturing methods not actually used by the brand-name sponsor

Allows courts to increase the patent limit for good cause, including when a biosimilar applicant fails to provide required information or materially changes their product or manufacturing process

Exempts patents claiming methods of therapeutic use (such as indications or treatment methods) from the numerical limitation

Applies to biosimilar applications submitted under the Public Health Service Act section 351(k) on or after the date of enactment