This bill changes patent rules for biological products (like many modern medicines). It updates 35 U.S.C. 271(e) to say that submitting information to get approval for a biological product can infringe patents that claim the product, its uses, or methods and materials used to make it. If the maker of an approved biologic (the reference product sponsor) sues a company seeking approval of a similar product under section 351(k) of the Public Health Service Act, the sponsor may assert up to 20 patents in that lawsuit. No more than 10 of those patents may have issued after a specific date tied to section 351(l)(7)(A).
The bill lists which patents count toward the limit: patents that claim the biological product or its uses, patents on manufacturing methods or materials, patents that appear on certain patent lists under section 351(l), and patents with certain filing dates or claims not used by the reference product. A court may allow more patents in special cases, for example if justice requires it or for "good cause" such as when the applicant failed to provide required information, when the applicant materially changed the product or process, or when a patent issuance was delayed by the Patent Office. The court can also consider whether the reference product sponsor gave enough information to explain why extra patents are needed.
The limit on asserted patents only applies if the applicant seeking approval completes specified actions under section 351(l) and does not apply to patents that claim methods of using the biological product in treatment, diagnosis, or prevention. The amendments apply to 351(k) applications filed on or after the bill's enactment date.
No publicly available information on costs or savings is included in the bill text or provided metadata.
No publicly available information on proponents' stated reasons or arguments is included in the bill text or provided metadata.
No publicly available information on opponents' stated reasons or arguments is included in the bill text or provided metadata.